Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 2 years

Study design: single‐centre randomised controlled trial

Participants

80 participants in total

Male:Female: 17:23; 15:25

Age, years (range): 72 (65 to 80); 74 (64 to 82)

Inclusion criteria: non‐diabetic patients who had no previous knee surgery; normal neurovascular supply to the leg (proved by Doppler)

Duration of illness: unspecified

Interventions

Group A (n = 50): total knee replacement surgery performed with a tourniquet

Group B (n = 50): total knee replacement surgery performed without a tourniquet

All operations were performed under general anaesthesia by one surgeon. For all patients, cefuroxime 1.5 g was given intravenously at the time of induction of anaesthesia and two further doses of 750 mg were given postoperatively. Anticoagulant prophylaxis was with Fragmin, started 2 hours preoperatively and continued postoperatively until the patient was fully mobile. A pneumatic tourniquet was placed around the thigh in both groups but was inflated only for patients in group A. The limb was first exsanguinated by elevation for 2 minutes, and the tourniquet was inflated to twice the systolic blood pressure (in group A)

Outcomes

1. Hospital for Special Surgery knee score: knee‐related score assessing pain, stability (measured as total varus‐valgus arc, extension), motion (measured as total passive arc), quadriceps strength (measured as 10% of normal for age and gender), and subtractions for contractures or fixed varus/valgus. Score ranges from 0 to 100. The higher the score, the better the outcome

2. Postoperative pain on a linear analogue scale between 0 and 10. A score of 10 is the highest pain score; therefore the lower the score, the better the outcome

3. Analgesia consumption: measures as the total amount of opiate injected, measured in milligrams delivered to the patient. A higher score indicates a worse outcome. This was measured over the first 24 hours postoperatively

4. Duration of surgery: measured in minutes

5. Overall blood loss: measured in millilitres on day 1 postoperatively. The higher the score, the worse the outcome

6. Range of knee movement at 5 days, 10 days, and 6 weeks. Measured as time to straight leg raised, measured in days, with higher scores indicating worse outcomes, Knee extension and flexion measured in degrees with higher scores indicating better outcomes. These scores were measured at days 5 and 10, at week 6, and 1 year postoperatively

Identification

Contact information: A Abdel‐Salem, Consultant orthopaedic surgeon, George Elliot Hospital NHS Trust, Nuneaton, CV10 7DJ

Notes

Country: UK

Language: English

Study author contacted: no contact details given

Trial registry record or protocol available: none found

Funding source/declaration of interest: none reported

Adverse events:

In group A: 5 patients had wound infection; 3 patients had confirmed venous thrombosis

In group B: no adverse events were reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Card system

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

HSS, pain, analgesia consumption

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition; no CONSORT diagram

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement; no protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: up to 24 hours post surgery

Study design: single‐centre randomised controlled trial

Participants

20 participants in total

Male:Female: 3:10; 4:6

Age, years (SD): 70(8); 68 (4.5)

BMI, years (SD): 27.9; 27.3

Inclusion criteria: patients undergoing total knee replacement surgery for osteoarthritis

Exclusion criteria: disturbances of coagulation, history of deep vein thrombosis, previous surgery of the knee, neoplastic disease, inflammatory disease, had received anticoagulant therapy or drugs that affected the haemostatic system during the last 2 weeks

Duration of illness: unspecified

Interventions

Group I (n = 10): total knee replacement surgery performed with a tourniquet

Group II (n = 10): total knee replacement surgery performed without a tourniquet

Anaesthetic techniques were standardised. All patients received subarachnoid spinal anaesthesia by injection of 4 mL of 0.5% bupivacaine at the L2‐L3 interspace approximately 1 hour before surgery and were sedated with midazolam and fentanyl intravenously. Ringer’s lactate solution was infused as needed to maintain haernodynamic stability. Patients did not receive blood transfusions during the observation period. Autologous blood was transfused postoperatively as needed after the study was completed. Unilateral primary cemented total knee replacements (M.B.K. prosthesis, Zimmer, Warsaw, IN, USA) were performed on all patients by the same surgeon at approximately the same time of the morning. Patients were assigned randomly to either Group I or Group II. Group I comprised 10 patients who underwent total knee replacement with a tourniquet inflated at the root of the limb. Group II consisted of 10 patients who underwent total knee replacement without the tourniquet. Before the surgical incision was begun in patients in Group I, the limb was exsanguinated with an elastic bandage and the tourniquet inflated at the pressure of 0.8 bar

Outcomes

1. Duration of surgery: measured in minutes

2. Intraoperative blood loss: measured in millilitres. The higher the score, the worse the outcome

3. Postoperative blood loss: measured in millilitres. The higher the score, the worse the outcome

4. Overall blood loss: measured in millilitres. The higher the score, the worse the outcome

5. Intravenous fluid usage: measured in millilitres. The higher the score, the worse the outcome

6. Prothrombin time, activated partial thromboplastin time, and fibrinogen level: venous blood samples were drawn after 4 mL of blood was discarded to clear the venous line and to prevent haemodilution. Samples were collected via a 3‐way stopcock from a 14‐gauge antecubital vein cannula at the following 4 times: 1 hour before anaesthesia (Sample Tl); after bone cuts (Sample T2); 2 minutes after tourniquet deflation (Group I) or after cementing the prosthesis (Group 11) (Sample T3); and 1 hour after the end of the operation (Sample T4). Samples were collected in citrated tubes (9:1 volume to volume), immediately placed in ice, and centrifuged at 2000 g for 10 minutes at 4° C. Plasma samples were stored immediately at ‐70°C until assay

Identification

Contact information: P Aglietti, MD, Second Orthopaedic Clinic, Largo P. Palagi 1, 50139, Florence, Italy

Notes

Country: Italy

Language: English

Study author contacted: yes, however, received no reply

Trial registry record or protocol available: none found

Funding source/declaration of interest: none reported

Adverse events: none reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 3 months

Study design: single‐centre randomised controlled trial

Participants

81 participants in total

Male:Female: 18:20; 22:21

Age, years (SD): 68 (7.4); 69.7 (6.4)

BMI (SD): 28.6 (3.4); 27.9 (3.5)

Inclusion criteria: patients between 50 and 80 years of age undergoing total knee replacement surgery for treatment of primary osteoarthritis

Exclusion criteria: revision surgery, valgus deformity > 30°, 1‐stage bilateral procedures, rheumatoid arthritis, BMI > 35

Duration of illness: unspecified

Interventions

Group A (n = 38): total knee replacement surgery performed with a tourniquet

Group B (n = 41): total knee replacement surgery performed without a tourniquet

One group underwent surgery with a tourniquet (34 in., single bladder, dual port, Zimmer) around the thigh that applied pressure of 300 mmHg; the other group underwent surgery without a tourniquet. No femoral nerve block was used. A standard medial parapatellar incision was used
The cemented NexGen CR‐ or PS‐Flex fixed bearing knee (Zimmer) prosthesis was used without patellar resurfacing. Infiltration with 150 mL of ropivacaine‐supplemented ketorolac and adrenaline was applied during surgery. If a tourniquet was used, it was released after the bandages were applied. Tranexamic acid (1 g) was given intravenously, 10 minutes before surgery in the non‐tourniquet group, and 10 minutes before tourniquet release in the tourniquet group. 2 g of cloxacillin was administered intravenously just before and twice after surgery. Low‐molecular‐weight heparin (Fragmin, 5000 IE subcutaneously) was used for the first 14 postoperative days. Postoperative pain management included oxycodone 5 to 10 mg (controlled‐release oral formulation) twice a day, paracetamol 1 g 4 times a day, and oxycodone 5 mg when needed

Outcomes

Primary outcome

Active range of motion (AROM) in the knee is measured before surgery, at day 3, and at 3‐month control with a goniometer, with the patient lying supine

Secondary outcomes:

1. Timed up and go (TUG) is carried out before surgery, at day 3, and at 3‐month control. TUG is a functional test in which the time taken for the patient to get up from a chair, walk 3 metres, turn, and sit down again is measured

2. Visual analogue scale (VAS) is used for pain assessment. The patient answers the question, “How painful is your leg?” according to a 0 to 10 scale. This is done before surgery, 24 hours after surgery, 72 hours after surgery (± 2 hrs), and at 3‐month control. The question is asked before training while the patient is at rest, and any additional analgesia given is noted

3. Swelling is assessed by measuring the circumference 10 cm proximal to the superior border of the patella, at the superior border of the patella, and 10 cm distal to the superior border of the patella with the patient lying supine. This is done before surgery, at day 3, and at 3‐month control

4. Quadriceps function is tested by asking the patient to perform a straight leg raise while lying supine with the other leg in flexion with the foot on the base of support. The result is noted as able to/not able to perform the action. This is carried out before surgery, at day 3, and at 3‐month control

5. Gait speed is assessed using the 10‐metre walk test. Patients are asked to walk as quickly and safely as possible for 14 metres, of which the middle 10 metres are timed

6. Patients are asked to fill in the Oxford 12‐Item Knee Score, which is a well‐validated outcome questionnaire designed for use with knee arthroplasty patients

Identification

Contact information: Staffan Eriksson, Centre for Clinical Research Sormland, Uppsala University, Kungsgatan 1, 531 88 Eskilstuna, Sweden, [email protected]

Notes

Country: Sweden

Language: English

Study author contacted: no

Trial registry record or protocol available: clinical trial number ISRCTN85166072

Funding source/declaration of interest: none reported

Adverse events:

In non‐tourniquet group: 1 patient had a urinary tract infection

In tourniquet group: 2 patients had a wound infection

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Computer‐generated random numbers table

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that a surgeon would alter his or her performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: TUG, VAS, and OKS

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: swelling, quadriceps function, and gait speed

Outcome assessors were blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 3 months

Study design: single‐centre randomised controlled trial

Participants

70 participants randomised
Mean age in tourniquet group: 65.39% 7.25; mean age in control group: 4.90% 6.58
Male:Female: 14:18; 14:19
Mean BMI in tourniquet group: 31.38 ± 4.72; mean BMI in control group: 30.31 ±.10
Inclusion criteria: patients undergoing total knee replacement surgery with a diagnosis of osteoarthritis (stage 3 to 5 on Ahlback rating), BMI < 35, and ASA score of I or II
Exclusion criteria: ASA > III, BMI > 40, diagnosis of secondary gonarthrosis, preoperative range of motion < 90 degrees in affected knee, concomitant neuromuscular or orthopaedic disorders that can affect recovery of the lower limb, concomitant rheumatological disorder, concomitant peripheral vascular disease, diabetes mellitus, history of previous knee surgery, use of anticoagulant medication, and unwillingness to participate in the study
Duration of illness unspecified

Interventions

Intervention:
In Group A, exsanguination was accomplished by wrapping the limb with an elastic bandage approximately 10 cm wide, starting at the toes and continuing to just distal to the tourniquet. Next, cuff pressure was inflated to 100 mmHg above systolic blood pressure
In Group B, a tourniquet was applied; however, it was not inflated
All TKAs were performed by the same surgeon (O.A.), who specialised in hip and knee replacement according to a standard protocol, which included spinal anaesthesia, an appropriate perioperative antibiotic regimen for infection prophylaxis, thrombosis prophylaxis, postoperative pain management, and rehabilitation. Low‐molecular‐weight heparin was started 12 hours before spinal anaesthesia for thrombosis prophylaxis and was concluded when patients were completely mobile. The surgical course involved a midline skin incision made via a standard medial parapatellar approach. All patients in both groups received the GENESIS II cemented, posterior cruciate ligament‐retaining, fixed‐bearing total knee endoprosthesis with ultra‐high‐molecular‐weight polyethylene (Smith & Nephew Orthopedics, Inc., Memphis, TN, USA). An intramedullary guide was utilised for the femur and an external guide for the tibia. The patella was not replaced in any case, and only marginal osteophytes were removed. Dressings were applied after wound closure, and the cuff was rapidly deflated in Group A

Outcomes

1. Isokinetic muscle strength of knee extensors (quadriceps) and flexors (hamstrings) was measured in Newton meters (Nm) by a CYBEX 350 isokinetic dynamometer (‐ HUMAC/CYBEX 2009, Stoughton, MA, USA). In both groups, peak torque and total work were evaluated preoperatively and at 1 and 3 months postoperatively

2. Knee Society score measured at 1 and 3 months postoperatively

3. Pain measured on a visual analogue score at 1 and 3 months postoperatively

4. Knee range of motion measured at 1 and 3 months postoperatively

Identification

Contact information: Mehmet Demirel, MD, Department of Orthopaedics and Traumatology, Istanbul University, Istanbul School of Medicine, Istanbul, Turkey, [email protected]

Notes

Country: Turkey
Language: English
Study author contacted: no
Trial registry record or protocol available: study was approved by the local ethics committee (1127‐Istanbul University)
Funding source/declaration of interest: no source of funding reported or identified
Adverse events: no adverse events reported in groups
Number in each group 35:35

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomised

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded 

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Participants were blinded; therefore low risk of bias

Self‐reported outcomes: KSS, pain

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors are blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources identified

Study characteristics

Methods

Three groups: surgery without a tourniquet; surgery with a tourniquet at low pressure (225 mmHg); surgery with a tourniquet at high pressure (350 mmHg)

Follow‐up: 7 days

Study design: single‐centre randomised controlled trial

Participants

31 participants in total

Male:Female: not reported

Age, years (SD): not reported

BMI (SD): not reported

31 participants

Inclusion criteria: patients undergoing total knee replacement surgery

Exclusion criteria: patients with non‐osteoarthritic disease, previous open knee surgery, systemic or local hypoxia, receiving anticoagulant or antiplatelet agents or steroid, with significant varus or valgus deformity or preoperative lateral release

Duration of illness: unspecified

Interventions

Group A: surgery without a tourniquet (n = 10)

Group B: surgery with a tourniquet at low pressure (225 mmHg) (n = 10)

Group C: surgery with a tourniquet at high pressure (350 mmHg) (n = 11)

A standard protocol was followed utilising a tourniquet 11.5 cm wide, with an effective pressurising width of 9 cm (DePuy UK Ltd, Leeds, UK), with exsanguination in extension via a Rhys‐Davies device where appropriate. All patients had general (non‐halothane) anaesthesia, a midline skin incision, a medial parapatellar approach, insertion of a cemented Insall‐Burnstein II TKR (Zimmer, Warsaw, IN, USA), and skin closure using continuous Vicryl (Ethicon Ltd, Somerville, NJ, USA) over a single drain. All were mobilised on the second postoperative day. No patient received thromboembolic prophylaxis or used a continuous passive motion machine

Outcomes

1. Blood transfusion use: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

2. Wound hypoxia: measurement of tissue oxygenation was performed with transcutaneous oxygen pressure electrodes (Radiometer Ltd, Crawley, UK) placed on the skin. Electrodes were placed on each wound flap with a reference electrode sited in the infraclavicular region to determine intrapatient and interpatient differences in systemic oxygen delivery both before and after operation. Electrodes were attached to 2 Radiometer TCM3 TINA units (Radiometer Ltd). Measurements were taken before operation and on each day after surgery for 1 week or until discharge from hospital

3. Return to preoperative levels of oxygenation

4. Subjective assessment of wound healing: assessed by 2 observers for haematoma, infection, skin necrosis, dehiscence, or contusion

Identification

Contact information: Mr M.T. Clarke, Box 37, Orthopaedic Surgery, Addenbrookes Hospital, Cambridge, CB2 2QQ

Notes

Country: UK

Language: English

Study author contacted: yes, no reply from author.

Trial registry record or protocol available: none reported

Funding source/declaration of interest: funded by grants from the Wishbone Trust and from the research and development fund of West Suffolk Hospital

Adverse events: none reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors are blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

2 groups: surgery performed with a tourniquet inflated; surgery performed without a tourniquet inflated
Follow‐up: 1 year
Study design: single‐centre randomised controlled trial

Participants

129 participants randomised
Mean age in tourniquet group 68.2 ± 17.1; mean age in non‐tourniquet group 69.5 ± 15.9
Male:Female: 20:38; 23:41
Mean weight in tourniquet group 67.7 ± 17.6; mean weight in non‐tourniquet group 65.9 ± 15.9
Inclusion criteria: patients who were 60 to 85 years old, undergoing unilateral total knee replacement surgery, NYHA classification I to III, ASA physical status I and II
Exclusion criteria: severe cardiovascular or cerebrovascular disease, illiteracy, mental illness, cognitive impairment, refusal to participate in the study
Duration of illness: unspecified

Interventions

Patients in both groups were anaesthetised by general anaesthesia. General anaesthesia induction drugs included midazolam 0.5 mg/kg, propofol 1.5 mg/kg, sulfentanyl 0.5 μg/kg, and rocuronium 0.8 mg/kg by intravenous bolus injection. Intermittent injection of rocuronium 10 mg per 40 to 60 minutes, continuous intravenous infusion of remifentanil 0.1 to 0.3 μg/kg/min, and propofol 2 to 4 mg/kg/h; continuous inhalation of sevoflurane was used for anaesthesia maintenance. All patients underwent TKA via a standardised technique and process
Patients in group T underwent surgery with a tourniquet inflated to 100 mmHg above systolic blood pressure; patients in group H underwent surgery without a tourniquet
The orthopaedic surgeon injected 20 mL of a ‘cocktail mixture’ into the posterior capsular ligament, peripheral capsular ligament, and ligamentum patellae before the artificial prosthesis was embedded to relieve pain and inflammation. The formula for the ‘cocktail’ is as follows: ropivacaine 100 mg, tranexamic acid 3 g, adrenaline 3 drops, methylprednisolone 40 mg, in a total volume of 20 mL with the addition of normal saline

Outcomes

1. Pain assessed via a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Collected on days 1, 2, 3, and 7 and 1 year after the operation

2. Active range of motion measured in degrees; collected on days 1, 2, 3, and 7 and 1 year after the operation

3. Intraoperative blood loss

4. Total blood loss

5. Circumferences of the lower and middle thighs of patients were measured before the operation and on day 1, day 2, and day 3 after the operation, to judge swelling of the operative side thigh

6. A Montreal Cognitive Assessment Scale (MoCA) with a total score of 30 points was used to analyse the cognitive function of patients on day 1, day 2, day 3, and day 7 after the operation. MoCA value < 26 points was considered to show cognitive impairment

7. Serum creatinine

8. Glomerular filtration rate collected on days 1, 2, and 3 postoperatively

9. C‐reactive protein collected on days 1, 2, 3, and 7 postoperatively

Identification

Contact information: Jun Dong, [email protected], Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China

Notes

Country: China
Language: English
Study author contacted: no
Trial registry record or protocol available: protocol was approved by the ethics committee of the First Affiliated Hospital of Chongqing Medical University (2012‐2‐21) and was registered at ClinicalTrials.com (NCT02576015)
Funding source/declaration of interest: no source of funding reported or identified
Adverse events: no adverse events reported in groups
Number in each group: 66:63

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Insufficient information to permit judgement

Self‐reported outcomes: pain, Montreal Cognitive Assessment Scale

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Insufficient information to permit judgement

Assessor‐reported outcomes: range of motion, blood loss, thigh swelling, serum creatinine, GFR, CRP

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 12 months

Study design: single‐centre randomised controlled trial

Participants

64 participants in total

Male:Female: 18:15; 17:14

Age, years (SD): 68 (8.4); 68 (7.8)

BMI (SD): 25 (2.0); 25 (2.5)

Inclusion criteria: patients aged 50‐85 undergoing an elective unilateral total knee replacement because of arthritis

Exclusion criteria: rheumatoid arthritis, peripheral vascular disease, diabetes, prior knee surgery, use of anticoagulant medication, BMI > 35

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 33)

Group B: surgery performed without a tourniquet (n = 31)

All procedures were standardised with regard to preoperative tranexamic acid, spinal anaesthesia, postoperative pain treatment, and rehabilitation regimen. Before surgery, tranexamic acid (1 g) was administered orally, and cefuroxime (1.5 g) was administered intravenously immediately before skin incision. In addition, tranexamic acid (0.5 g) was given 3 hours after surgery, and cefuroxime (750 mg) was given 6 and 12 hours postoperatively. Thrombosis prophylaxis was achieved with the use of rivaroxaban (10 mg/d) throughout the hospital stay. Both groups had an appropriately sized thigh tourniquet applied, but it was inflated only in the Tq group; in the non‐Tq group, it was placed on the thigh but was not inflated, thereby serving as a safety device in case of uncontrollable bleeding. In the Tq group, limb exsanguination was done by elevation for 2 minutes, and the cuff was inflated to 250 mmHg

Outcomes

1. Knee Outcome and Osteoarthritis Severity score (KOOS) at 12 months: validated knee‐specific patient‐reported outcome measure consisting of 42 items in 5 subsets (pain, symptoms, activities of daily living, sports/recreation, quality of life); score ranges from 0 to 100; zero indicates extreme knee problems, and 100 represents no knee problems

2. Pain score on days 1 and 3 postoperatively. Assessed as a visual analogue scale between 0 and 10; zero indicates no pain, and 10 indicates extreme pain

3. Analgesia consumption was expressed as a mean morphine equivalent during hospitalisation; consumption was standardised with 10 mg of morphine used as reference analgesic dose

4. Duration of surgery: measured in minutes

5. Intraoperative blood loss: measured in millilitres. The higher the score, the worse the outcome

6. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

7. Deep vein thrombosis

Identification

Contact information: Ashir Ejaz, Department of Orthopaedic Surgery, Aslborg University Hospital, Aalborg, Denmark, [email protected]

No source of funding identified

Notes

Country: Denmark

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: clinical trials number NCT1209035

Funding source/declaration of interest: none reported

Adverse events:

In the tourniquet group: 2 patients had confirmed DVT, and 2 patients required further operations on the index knee

In the non‐tourniquet group: 1 patient had confirmed DVT

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomised

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: KOOS, pain, analgesia consumption, DVT

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across interventions

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 5 hours

Study design: single‐centre randomised controlled trial

Participants

62 participants in total

Male:Female: 16:15; 17:14

Age, years (SD): 68.3 (8.4); 68.2 (7.8)

BMI (SD): 25.1(2.0); 25.2 (2.5)

Inclusion criteria: patients aged 50 to 85 undergoing elective unilateral cemented total knee replacement because of arthritis

Exclusion criteria: rheumatoid arthritis, peripheral vascular disease, diabetes, prior knee surgery, use of anticoagulant medication, BMI > 35

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 31)

Group B: surgery performed without a tourniquet (n = 31)

All procedures were standardised with regard to preoperative tranexamic acid, spinal anaesthesia, postoperative pain treatment, and rehabilitation regimen. Before surgery, tranexamic acid (1 g) was administered orally and cefuroxime (1.5 g) was administered intravenously immediately before skin incision. In addition, tranexamic acid (0.5 g) was given 3 hours after surgery, and cefuroxime (750 mg) was given 6 and 12 hours postoperatively. Thrombosis prophylaxis was achieved with the use of rivaroxaban (10 mg/d) throughout the hospital stay. Both groups had an appropriately sized thigh tourniquet applied, but it was inflated only in the Tq group. In the non‐Tq group, it was placed on the thigh but was not inflated, thereby serving as a safety device in case of uncontrollable bleeding. In the Tq group, limb exsanguination was done by elevation for 2 minutes and the cuff was inflated to 250 mmHg

Outcomes

1. Change in pyruvate, glucose, lactate, and glycerol concentrations. Samples were taken from the dialysate fluid. Microdialysis catheters were inserted into the gastrocnemius muscle at the time of surgery. Samples were collected every 20 minutes postoperatively until 5 hours

2. Duration of surgery: measured in minutes

Identification

Contact information: Ashir Ejaz, Department of Orthopaedic Surgery, Aslborg University Hospital, Aalborg, Denmark, [email protected]

No source of funding identified

Notes

Country: Denmark

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: clinical trials number NCT1209035

Funding source/declaration of interest: none reported

Adverse events: none reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomised

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 24 months

Study design: single‐centre randomised controlled trial

Participants

57 participants in total

Male:Female: 13:16; 15:13

Age, years (SD): 68.3 (8.0); 68.2 (7.8)

BMI (SD): 25.1 (2.0); 25.2 (2.5)

Inclusion criteria: patients aged 50 to 85 undergoing elective unilateral total knee replacement because of arthritis

Exclusion criteria: rheumatoid arthritis, peripheral vascular disease, diabetes, prior knee surgery, use of anticoagulant medication, BMI > 35

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 29)

Group B: surgery performed without a tourniquet (n = 28)

All procedures were standardised with regard to preoperative tranexamic acid, spinal anaesthesia, postoperative pain treatment, and rehabilitation regimen. Before surgery, tranexamic acid (1 g) was administered orally, and cefuroxime (1.5 g) was administered intravenously immediately before skin incision. In addition, tranexamic acid (0.5 g) was given 3 hours after surgery, and cefuroxime (750 mg) was given 6 and 12 hours postoperatively. Thrombosis prophylaxis was achieved with the use of rivaroxaban (10 mg/d) throughout the hospital stay. Both groups had an appropriately sized thigh tourniquet applied, but it was inflated only in the Tq group. In the non‐Tq group, it was placed on the thigh but was not inflated, thereby serving as a safety device in case of uncontrollable bleeding. In the Tq group, limb exsanguination was done by elevation for 2 minutes and the cuff was inflated to 250 mmHg

Outcomes

1. Radiosterometric analysis (maximum total point motion) at 8 weeks, 6 months, 12 months, and 24 months. MTPM represents the vector length of a marker in the rigid body that has the longest translational motion, not considering direction, and always has a positive value. Translations along the axes were given as x‐translation (medial–lateral movement), y‐translation (superior/lift‐off and inferior/subsidence movement), and z‐translation (anterior and posterior movements). Rotations around the axes were expressed as x‐rotation, y‐rotation, and z‐rotation, which represent anterior‐posterior tilt, internal‐external rotation, and varus–valgus tilt, respectively

Identification

Contact information: Ashir Ejaz, Department of Orthopaedic Surgery, Aslborg University Hospital, Aalborg, Denmark, [email protected]

No source of funding identified

Notes

Country: Denmark

Language: English

Study author contacted: yes, no reply from author.

Trial registry record or protocol available: clinical trials number NCT1209035

Funding source/declaration of interest: none reported

Adverse events: none reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomised

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Assessor‐reported outcomes: RSA analysis

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

2 groups: surgery with a tourniquet; surgery performed without a tourniquet
Follow‐up: 8 months
Study design: randomised controlled trial performed at an academic university hospital and a private orthopaedic hospital

Participants

200 participants randomised
Mean age in the tourniquet group 66 (7); mean age in the non‐tourniquet group 65.5 (7.8)
Male:Female ratio: 50:50; 48:52
Mean BMI in the tourniquet group 30.9 (4.6); mean BMI in the non‐tourniquet group 31.3 (4.5)
Inclusion criteria: all unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion and diagnosis of osteoarthritis
Exclusion criteria: revision surgery, bilateral knee surgery, age < 18 or > 80, BMI > 40, baseline lower extremity strength < 5/5, vascular calcifications, history of chronic narcotic use defined as more than 5 mg of oxycodone q4 hours, functionally limiting spine disease, other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease), patients who cannot perform baseline functional tests, allergy/contraindication to protocol medications, post‐traumatic arthritis, Inflammatory arthritis, pregnancy, prisoners and patients receiving care as part of a workers' compensation injury

Duration of illness: unspecified

Interventions

In the tourniquet group, surgery was performed with a tourniquet inflated at 225 mmHg or 300 mmHg depending on surgeon preference. In the non‐tourniquet group, surgery was performed without a tourniquet
All total knee replacements were done with the patient under sedation and spinal anaesthesia utilising bupivacaine without an opioid. All patients received an adductor canal block, and a pneumatic tourniquet was applied to all patients. Patients received 1 g of intravenous tranexamic acid 30 minutes before the incision when it was deemed appropriate by the anaesthesiologist. A standard midline incision and a medial parapatellar approach were utilised for all surgical procedures. For patients randomised to tourniquet inflation, the tourniquet was inflated at the start of the procedure and was deflated after application of sterile dressings. Either the DePuy Synthes P.F.C. SIGMA or the Zimmer Biomet Persona implant system was used. The tourniquet system used was the Stryker Color Cuff Dual Port inflated to either 300 or 225 mmHg, depending on surgeon preference

Outcomes

1. Duration of surgery

2. Overall blood loss

3. Surgeon‐rated difficulty in visualisation

4. Pain measured on a visual analogue scale at 4 to 6 weeks and at 6 to 8 months

5. Stair climb test measured at 4 to 6 weeks and at 6 to 8 months

6. Time to up and go test measured at 4 to 6 weeks and at 6 to 8 months

7. KOOS score measured at 4 to 6 weeks and at 6 to 8 months

8. SF‐12 measured at 4 to 6 weeks and at 6 to 8 months

9. Wound complications

10. Deep vein thrombosis

Identification

Contact information: Rahul Goel, Department of Orthopaedic Surgery, Emory University, Atlanta, Georgia, USA
ORCID ID for R Goel: 0000‐0002‐0515‐0361

Notes

Country: USA
Language: English
Study author contacted: no
Trial registry record or protocol available: study was registered at ClinicalTrials.gov (NCT02907047)
Funding source/declaration of interest: no source of funding reported or identified
Adverse events:

1 person in the tourniquet group had a wound complication requiring antibiotics

1 patient in each group had postoperative wound blistering

1 patient in the non‐tourniquet group developed symptomatic DVT
Number in each group 100;100

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number generator

Allocation concealment (selection bias)

Low risk

Envelopes with allocation opened before incision

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: pain, satisfaction, SF‐12, KOOS

Patients blinded

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Outcome assessors blinded

Assessor‐reported scores: blood loss, duration of surgery, range of motion, stair climb test, time to up and go

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 48 hours

Study design: single‐centre randomised controlled trial

Participants

64 participants in total

Male:Female: 17:15; 18:14

Age, years (SD): 68 (8.0); 66 (8)

BMI (SD): 27.4; 28.4

Inclusion criteria: ASA I to III, able to understand given information, 45 to 85 years of age

Exclusion criteria: previous major knee surgery to the same knee, preoperative inability to flex the knee > 90 degrees, rheumatoid arthritis, allergy to any of the drugs used in the study

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 32)

Group B: surgery performed without a tourniquet (n = 32)

As premedication, all patients received oral celecoxib 400 mg and acetaminophen 1 g; thereafter 12‐hourly (celecoxib 200 mg) and 6‐hourly (acetaminophen 1 g). No subjects received an indwelling urinary catheter, and no drains were used. A low‐volume fluid regimen was used with 2000 mL of Ringer's solution during the first 24 hours. All subjects were given 1 g of tranexamic acid i.v. Oxycodone 5 mg i.v. was used as postoperative rescue pain medication. No femoral nerve blocks were used. All patients were anaesthetized using intrathecal administration of hyperbaric bupivacaine 0.5%, 3 mL. An infusion of propofol 10 mg mL−1 was given to induce light sedation during surgery. All patients breathed spontaneously with supplemental oxygen 2 L min−1

Outcomes

1. Knee extension strength: measured from pre‐surgery to 48 hours after surgery in the operated leg. Knee extension strength was measured isometrically at 60° knee flexion using an isokinetic dynamometer (Biodex) and was expressed as Newtons per kilo body mass

2. Pain: assessed as a visual analogue scale between 0 and 10; zero indicates no pain, and 10 indicates extreme pain

3. Swelling: not reported how this was collected.

4. Nausea: not reported how this was collected.

5. Duration of surgery: measured in minutes

Identification

A. Harsten, Department of Anaesthesiology, Hassleholm Hospital, Box 351, 281 25 Hassleholm, Sweden, telephone +46451298848, [email protected]

Notes

Country: Sweden

Language: English

Study author contacted: author not contacted

Trial registry record or protocol available: clinical trials number NCT01808859

Funding source/declaration of interest: study was supported by institutional grants

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Patients and surgeons not blinded

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

High risk

Self‐reported outcomes: pain and nausea

Patients not blinded; therefore high risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: knee extension strength, swelling, duration of surgery

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Three groups: surgery with a tourniquet as well as multiple doses of intravenous tranexamic acid (TXA); surgery with no tourniquet and multiple doses of TXA; surgery with a tourniquet and no TXA

Follow‐up: 6 months

Study design: single‐centre randomised controlled trial

Participants

150 participants in total

Male:Female: 18:32; 16:34

Age, years (SD): 66.2 (8.3); 65.1 (6.8)

BMI (SD): 25.1 (1.5); 24.4 (1.5)

Inclusion criteria: patients older than 18 scheduled for primary total knee arthroplasty for end stage‐osteoarthritis

Exclusion criteria: revision procedures, bilateral procedures, previous knee surgery, flexion deformity > 30 degrees, anaemia, contraindication for TXA, ASA grade IV, coagulation disorder

Duration of illness: unspecified

Interventions

Group A: surgery with a tourniquet and multiple doses of TXA (n = 50)

Group B: surgery without a tourniquet and multiple doses of TXA (n = 50)

Group C: surgery with a tourniquet and no TXA (n = 50)

A surgeon‐selected cemented posterior‐stabilised prosthetic design was used. Vacuum wound drainage was used for every patient and was removed the next morning. An intraoperative periarticular injection of ropivacaine and postoperative oral diclofenac sodium (Voltaren; 50 mg twice daily) were administered for pain. On the day of the surgery and 3 times daily thereafter until hospital discharge, all patients were evaluated by a physical therapist and began walking with partial weight‐bearing and wearing a knee brace to protect the surgical site

Outcomes

1. HSS score at 6 months: knee‐related score assessing pain, stability (measured as total varus‐valgus arc, extension), motion (measured as total passive arc), quadriceps strength (measured as 10% of normal for age and gender), and subtractions for contractures or fixed varus/valgus. Score ranges from 0 to 100. The higher the score, the better the outcome

2. Duration of surgery: measured in minutes

3. Intraoperative blood loss: measured in millilitres

4. Total blood loss: measured in millilitres

5. Transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

6. Length of hospital stay: measured in number of days

7. Patient satisfaction: all patients completed a satisfaction questionnaire regarding outcomes of surgery, which asked them to rate their satisfaction on a 7‐point scale ranging from very dissatisfied to extremely satisfied

8. Deep vein thrombosis

9. Pulmonary embolism

10. Swelling ratio: the swelling ratio was defined as the knee circumference of the operatively treated limb divided by the circumference of the contralateral limb, with the knee circumference encompassing the upper and lower poles of the patella

Identification

Contact information: ZeYu Huang, MD, PhD, Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Cheng Du, Sichuan Province, People's Republic of China

Notes

Country: China

Language: English

Study author contacted: no

Trial registry record or protocol available: registered on Chinese clinical trials registry ChiCTR‐INR‐16009762

Funding source/declaration of interest: none reported

Adverse events:

Group A: 1 patient had a superficial wound infection

Group B: no adverse events were reported

Group C: 3 patients developed a superficial wound infection and 3 patients reported blistering

We reported groups A and B in our analysis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded; surgeons blinded only until the morning of the operation

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: HSS score, patient satisfaction, DVT, PE

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: duration of surgery, intraoperative blood loss, total blood loss, transfusion rate, length of hospital stay, swelling

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 60 minutes postoperatively

Study design: single‐centre randomised controlled trial

Participants

34 participants in total

Male:Female: 8:15; 8:15

Age, years (SD): 70.6 (7); 70.6 (6)

BMI (SD): 32.1 (5); 33.8 (5)

Inclusion criteria: 55 to 85 years of age, osteoarthritis of the knee joint (degree III or IV), physical status (ASA I or II), BMI < 45, able to provide written informed consent

Exclusion criteria: < 55 or > 85 years of age, osteoarthritis of the knee joint (degree I or II), ASA physical status III or IV, BMI > 45, unable to provide written consent, malignant disease, rheumatoid disease, infectious disease, coagulation disorder, history of deep vein thrombosis or pulmonary embolism, peripheral arterial disease, immune deficiency, medication (glucocorticoid, aspirin, heparin, cumarin, warfarin), neurological dysfunction, liver insufficiency, coronary heart disease, immobility

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 17)

Group B: surgery performed without a tourniquet (n = 17)

After accomplishment of the anaesthesia, a pneumatic tourniquet was applied at the proximal third of the thigh. Thereafter, a standard sterilisation procedure was performed. The tourniquet was inflated (380 mmHg) immediately before the skin incision. The standard medial parapatellar approach was performed in all cases. For each of these groups, 2 biopsies were taken from the vastus medialis. The first muscle biopsy was obtained immediately after surgery was performed; this was followed by the second muscle biopsy exactly 60 minutes later (before tourniquet deflation). Biopsy volume was set to be 5 × 5 × 5 mm (125 mm³) with distance between biopsies > 10 mm. Muscle extracts were frozen in liquid nitrogen until further analyses

Outcomes

Primary outcome:

Measurement of intracellular proteolytic activity: the total ubiquitination, as a result of total ubiquitin‐protein ligase activity (tUbPL), was determined as biotinylated ubiquitin incorporation into the sum of the cytosolic proteins. The ubiquitination was expressed in katal, which is defined as 1 mol biotinylated ubiquitin incorporated into cytosolic proteins per second

Secondary outcomes:

1. Blood loss (1 week postoperative): measured in millimetres

2. Complication (within 6 months of operation date)

3. WOMAC score (6 months postoperatively): consists of 24 items divided into 3 subscales (pain, stiffness, and physical function). Total score is 96, with 0 indicating no problems with the knee and 98 representing extreme problems with the knee

4. Prosthesis position on radiograph (1 week postoperatively): not stated in protocol how this was to be measured

5. Nerve function analysis: not stated in protocol how this was to be measured

Identification

Contact information: Ahmed Jawhar, Department of Orthopaedics and Trauma Surgery, University Medical Centre Mannheim of University Heidelberg, Theodor‐Kutzer‐Ufer 1‐3, 68167 Mannheim, Germany, [email protected]

No conflicts of interest

Notes

Country: Germany

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: clinical trials ID NCT02475603

Funding source/declaration of interest: no sources of funding stated

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No missing outcome data

Selective reporting (reporting bias)

High risk

Outcomes in registration/protocol not reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

2 groups: surgery performed with a tourniquet; surgery performed without a tourniquet
Follow‐up: 6 months
Study design: single‐centre randomised controlled trial

Participants

99 participants included in this study
Mean age in the tourniquet group 69.3 (7.4); mean age in the non‐tourniquet group 68.3 (7.3)
Mean BMI in the tourniquet group 31.9 (6); mean BMI in the non‐tourniquet group 31.4 (5.5)
Male:Female ratio: 17:33; 19:30
Inclusion criteria: 50 to 85 years of age; Osteoarthritis Kellgren and Lawrence score III or IV; ASA score I, II, III; BMI < 45 kg/m²; able to provide written consent
Exclusion criteria: < 50 years or > 85 years of age, Osteoarthritis Kellgren and Lawrence score I or II, ASA IV,
BMI > 45 kg/m², unable to provide written consent, other implant designs, unicondylar knee arthroplasty, malignant disease, rheumatoid disease,
infectious disease, coronary heart disease, neurological dysfunction, immobility ‐ not able to walk
, liver insufficiency,
coagulation disorder, glucocorticoids, aspirin, heparin, coumadin, warfarin, history of DVT or pulmonary embolism
Duration of illness: unspecified

Interventions

All TKAs were performed at the Department of Orthopaedics and Trauma Surgery according to institutional standard operating procedure. Medial parapatellar approach and femur first surgical technique were performed to implant a cemented prosthesis design (SmartSet Bone cement, DePuy Synthes, Warsaw, IN, USA) (PFC® SIGMA®). After introduction of anaesthesia, a pneumatic tourniquet (Balbina™, Ulrich Medical, Ulm, Germany) was placed on the proximal thigh and was inflated only in the tourniquet group to 360 mmHg, immediately before skin incision. The tourniquet was released on completion of wound closure and after application of an elastic–compressive bandage. In the non‐tourniquet group, the same surgery was performed without a tourniquet

Outcomes

1. Oxford Knee Score collected at 6 weeks and 6 months

2. WOMAC score collected at 6 weeks and 6 months

3. Mancuso score collected at 6 weeks and 6 months

4. EQ‐5D (VAS and Index) collected at 6 weeks and 6 months

5. Hospital Anxiety and Depression score collected at 6 weeks and 6 months

6. Muscle strength (muscle peak force (Newton), workload (Joule), total workload (Joule), power (Watt)) collected at 6 weeks and 6 months

7. Complications such as postoperative haematoma, DVT/PE, surgical site infection, and vascular/nerve injury

Identification

Ahmed Jawhar, [email protected], Department of Orthopaedics and Trauma Surgery, University Medical Center Mannheim of University Heidelberg, Theodor‐Kutzer‐Ufer 1‐3, 68167 Mannheim, Germany

Notes

Country: Germany
Language: English
Study author contacted: no
Trial registry record or protocol available: the protocol was registered at clinicaltrials.gov (ClinicalTrials.gov NCT02475603). The Institutional Ethics Committee approved the protocol (file reference 2012‐334 N‐MA/University Medical Center Mannheim of University Heidelberg)
Funding source/declaration of interest: no source of funding reported or identified
Adverse events:
In the tourniquet group, 1 deep vein thrombosis occurred, 1 patient underwent revision surgery due to surgical site infection, 2 patients underwent revision surgery due to haematoma in the tourniquet groups
In the non‐tourniquet group, 1 patient had revision surgery due to surgical site infection, 2 patients had delayed wound healing, 1 patient with delayed wound healing needed revision surgery
Number in each group 50:49

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Insufficient information to permit judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources identified

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: 2 days

Study design: single‐centre randomised controlled trial

Participants

30 participants in total

Male:Female: 7:9; 4:10

Age, years (range): 69 (52 to 89); 64 (46 to 86)

BMI (SD): not reported

Inclusion criteria: patients undergoing primary cemented TKR

Exclusion criteria: patients younger than 18 years, recent (< 6 months) myocardial infarction, unstable angina, severe aortic or mitral valve stenosis, previous stroke, unmedicated hypertension, treatment with beta‐antagonist or anticoagulant

Duration of illness: unspecified

Interventions

Group A: surgery performed with epidural anaesthesia without a tourniquet (n = 14)

Group B: surgery performed with spinal anaesthesia and a tourniquet (n = 16)

In all cases, the leg planned for operation was exsanguinated with an Esmarch bandage before the tourniquet was inflated around the upper femur; tourniquet inflation pressure was maintained at 350 to 400 mmHg during the operation. At the end of surgery, the surgeon deflated the tourniquet to enable establishment of haemostasis; during surgery, sedation was adjusted to a level where communication was possible. Oxygen was delivered at 3L/min on a nasal catheter. All patients had urine output monitored via a urinary bladder catheter

Outcomes

1. Mean arterial pressure: measured intraoperatively calculated as (cardiac output multiplied by systemic vascular resistance) added to central venous pressure

2. Intraoperative blood loss: measured in millilitres through volume in the suction apparatus and weighing of towels

3. Postoperative blood loss: measured in millilitres through volume in postoperative drains

4. Total blood loss: measured in millilitres

5. Intravenous fluid usage: measured in millilitres as the amount of colloid or crystalloid administered in the first 24 hours

6. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

7. Blood hematocrit, creatinine, APTT, and platelet level at 1, 3, and 7 days postoperatively

8. Postoperative arterial pH and base excess

Identification

Contact information: Palle Juelsgaard, MD, Tokkerbakken 20, DK‐8240, Risskov, Denmark, [email protected]

No source of funding stated

Notes

Country: Denmark

Language: English

Study author contacted: not contacted

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no sources of funding stated

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded; insufficient information on whether surgeons were blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

High risk

Had potential source of bias related to specific study design (different methods of anaesthesia)

Study characteristics

Methods

Two groups: surgery with a tourniquet; surgery without a tourniquet

Follow‐up: no follow‐up beyond operation

Study design: single‐centre randomised controlled trial

Participants

46 participants in total

Male:Female: 2:20; 2:23

Age, years (SD): 65 (10); 63 (8)

BMI (SD): not reported

Inclusion criteria: patients due to undergo primary total knee replacement surgery

Exclusion criteria: none stated

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 22)

Group B: surgery performed without a tourniquet (n = 24)

Anaesthesia was induced with intravenous propofol (1.5 mg/kg) and fentanyl citrate (0.1 mg). Tracheal intubation was facilitated with vecuronium bromide (0.1 mg/kg); anaesthesia was maintained with 66% nitrous oxide in 33% oxygen and sevoflurane. During the operation, all patients were ventilated with a tidal volume of 10 mL/kg and had a respiratory rate of 10 breaths/min. In the tourniquet group, the involved limb was exsanguinated by elevation and an Esmarch bandage, after which a pneumatic thigh tourniquet was applied to the limb and was inflated to pressure of 350 mmHg. No tourniquet was applied to the legs of control patients. The same surgeon performed all procedures; a similar surgical technique was used in each patient

Outcomes

1. Number of embolic events: measured via ultrasound. To identify the residue, it was Sudan‐stained to detect fat and Giemsa‐stained to detect thrombus and bone marrow. Echogenic materials were graded as follows: Grade 0 no emboli, Grade 1 few fine emboli, Grade 2 a cascade of fine emboli or embolic masses < 5 mm, Grade 3 fine emboli mixed with large embolic masses > 5 mm

2. Duration of surgery: measured in minutes

3. Pulmonary embolism

4. Mean arterial pressure: measured intraoperatively, calculated as (cardiac output multiplied by systemic vascular resistance) added to central venous pressure

5. Blood loss: measured in millilitres

6. Tranfusion volume: measured as total volume of blood transfused to all patients in millilitres

Identification

Contact information: Dr. Kato, Department of Anesthesia, Chiba Hokusoh Hospital, Nippon Medical School, 1715 Kamakari, Inba‐mura, Inba‐gun, Chiba 270‐1694, Japan, n‐[email protected]

No sources of funding mentioned for this study

Notes

Country: Japan

Language: English

Study author contacted: yes, no reply from the author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no sources of funding stated

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgment

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors are blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery with epinephrine‐augmented hypotensive anaesthesia without use of a tourniquet; normotensive epidural anaesthesia with a tourniquet

Follow‐up: 6 days

Study design: single‐centre randomised controlled trial

Participants

100 participants in total

Male:Female: 13:36; 10:41

Age, years (SD): 74.7 (7.4); 72.6 (7.1)

BMI (SD): 28.5 (3.3); 28.8 (3.9)

Inclusion criteria: patients listed for total knee replacement surgery, ASA grade I and II

Exclusion criteria: patients with history of myocardial infarction with angina, severe aortic or mitral valve stenosis, untreated hypertension, renal disease, preoperative bleeding disorders

Duration of illness: unspecified

Interventions

Group A: surgery performed with epinephrine‐augmented hypotensive epidural anaesthesia and no tourniquet group (n = 49)

Group B: surgery performed with normotensive epidural anaesthesia with tourniquet group (n = 51)

All patients were given oral premedication of 7.5 mg midazolam. Arterial blood pressure was monitored by inserting a 20‐gauge cannula into the radial artery. In all patients, a central venous catheter was placed into the right internal jugular vein to measure central venous pressure. The catheter also was used to administer the epinephrine infusion to the group of patients who received EAHEA (Group A)
In Group A, patients received 100 to 200 mL Ringer’s solution (Fresenius Kabi Austria GmbH, Graz, Austria) before the epidural dose as a fluid preload. Epidural anaesthesia was done at the Th12‐L1 and L1‐L2 interspace by a paramedian approach with ropivacaine 1% (20 to 30 mL) and fentanyl (50 micrograms)

In Group B, patients received 500 mL Ringer’s solution (Fresenius Kabi Austria GmbH) before the epidural dose as fluid preload. Epidural anaesthesia was administered at the L3‐L4 and L4‐L5 interspaces through a paramedian approach with ropivacaine 1% (15 mL) and fentanyl (50 micrograms)

Outcomes

1. Change in haemoglobin: haemoglobin measured in grams/dL was taken via blood sample at 6 hours and days 1 to 6 postoperatively

2. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

3. Duration of surgery: measured in minutes

Identification

Contact information: Martin Raffl, MD, Clinic for Anesthesiology and Intensive Care, Paracelsus Medical Private School, Salzburg, Muellner Hauptstrasse 48, A‐5020, Salzburg, Austria Phone 0043‐662‐4482‐2701; Fax 0043‐662‐4482‐2703; [email protected]

Notes

Country: Austria

Language: English

Study author contacted: yes, no reply from the author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no sources of funding stated

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgment

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: change in haemoglobin, blood transfusion rate, duration of surgery

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

High risk

Had potential source of bias related to specific study design

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 6 weeks

Study design: single‐centre randomised controlled trial

Participants

30 participants in total

Male:Female: 9:21

Age, years (range): 58 (45 to 69)

BMI (SD): not reported

Inclusion criteria: patients undergoing bilateral total knee replacement

Exclusion criteria: patients with severe cardiac comorbidities or neurological problems

Duration of illness: unspecified

Interventions

30 patients undergoing bilateral knee replacement surgery

Group A: surgery performed with a tourniquet (n = 30)

Group B: surgery performed without a tourniquet (n = 30)

All surgeries were performed by the same surgical team with standard technique. Epidural anaesthesia was used in all patients given with epidural morphine 50 mg/kg along with 0.1% bupivacaine in 10 mL normal saline. Along with that, IV diclofenac sodium was used twice daily for 5 days postoperatively and then was shifted to oral formulation accordingly. Both knees were prepared at the same time, and a single set of instruments were used. One knee was operated first and then the other by senior author [CSY]. All patients received perioperative antibiotics (amoxicillin‐clavulanic acid 1.2 grams intravenously).
The thigh that will receive the tourniquet pressure will be randomised according to a coin toss just before the start of surgery. The tourniquet cuff used was 85 cm long and 8.5 cm wide One soft roll pad was applied between the skin and the cuff
In thigh 1, tourniquet used side was inflated to systolic blood pressure plus 100 mmHg and was released after the first quadriceps stitch. Haemostasis was achieved before closure. The wound was closed after wound irrigation, then elastic bandages were applied. In thigh 2, the tourniquet was wrapped around the thigh but was not inflated during surgery

Outcomes

1. Pain score at days 1, 2, 3, weeks 2 and 6 postoperatively: assessed on a visual analogue scale between 0 and 10; zero indicates no pain, and 10 indicates extreme pain

Identification

Corresponding author: c/o Bipin Kumar, Sector‐4/D, Quarter No. 1038, Bokarosteel City, Jharkhand, India, [email protected] (N. Kumar)

Notes

Country: India

Language: English

Study author contacted: no

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no sources of funding stated

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Coin toss

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Self‐reported outcome: pain

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: none

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 2 years

Study design: single centre randomised controlled trial

Participants

50 participants in total

Male:Female: 10:15; 9:14

Age, years (SD): 70 (8); 71 (6)

BMI (SD): 29 (4.8); 28 (4.8)

Inclusion criteria: patients on the waiting list for elective primary total knee surgery due to arthritis, ASA I or II

Exclusion criteria: Inability to give informed consent, rheumatic arthritis, malignancy, coagulation disorder or medical treatment influencing coagulation, liver disease, severe heart disease, bilateral operation

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 25)

Group B: surgery performed without a tourniquet (n = 25)

All operations were done under spinal anaesthesia. The Nexgen CR all‐poly tibia knee prosthesis (Zimmer) was inserted after pulsed lavage and was cemented with Palacos R + G (Heraeus Medical Nordic, Sollentuna, Sweden) (40 g Palacos and 0.5 g gentamicin). 2 g cloxacillin was given intravenously just before and 3 times after the operation Low–molecular‐weight heparin (Innohep, 4500 IE subcutaneously) was used for the first 14 postoperative days

Outcomes

1. Maximum total point motion at 6 months, 12 months, and 24 months: MTPM represents vector length of a marker in the rigid body that has the longest translational motion, not considering direction, and always has a positive value. Translations along the axes were given as x‐translation (medial–lateral movement), y‐translation (superior/lift‐off and inferior/subsidence movement), and z‐translation (anterior and posterior movements). Rotations around the axes were expressed as x‐rotation, y‐rotation, and z‐rotation, which represent anterior‐posterior tilt, internal‐external rotation, and varus–valgus tilt, respectively

2. Pain: assessed as a visual analogue scale between 0 and 10; zero indicates no pain, and 10 indicates extreme pain

3. Blood loss: measured during surgery by weighing the surgical sponges and by subtracting the amount of irrigation fluid used from the content of the suction drain. Postoperative overt bleeding volume (in the drains) was estimated by measuring the haemoglobin content of the drains in relation to the blood haemoglobin concentration. Total blood loss was estimated by the haemoglobin dilution method based on blood volume

4. Range of motion: ROM was measured before surgery and after 3 days, 4 days, 6 weeks, 3 months, 6 months, 1 year, and 2 years. These measurements were performed by a physiotherapist who did not know whether a tourniquet had been used

Identification

Contact information: Department of Orthopedics, Aleris Specialist Care Motala; Department of Orthopedics, Linköping University Hospital, Linköping; Department of Orthopedics, Oskarshamn Hospital, Oskarshamn, Sweden, [email protected]

Notes

Country: Sweden

Language: English

Study author contacted: no

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: the study was funded by Swedish Research Council (VR‐2009‐6725)

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomised

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcome: pain

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: MTPM, blood loss, range of motion

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 7 days

Study design: single‐centre randomised controlled trial

Participants

60 participants in total

Male:Female: 9:21; 10:20

Age, years (SD): 71 (7); 70 (7)

BMI (SD): 24 (5); 24 (5)

Inclusion criteria: patients with initial unilateral TKA osteoarthritis (OA), rheumatoid arthritis (RA)

Exclusion criteria: patients with diabetes, haemorrhagic haematological disease, haemoglobin (Hb) < 100 g/L, peripheral neurovascular disease, malignant tumour, history of vascular embolism, history of infection in the affected lower limb

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 30)

Group B: surgery performed without a tourniquet (n = 30)

All surgical prostheses were replaced with posterior cruciate ligament instead of a cemented artificial knee joint (GENES II, Smith & Nephew, Andover, MA, USA). Surgery was performed by the same group of physicians using the midvastus route. 3 g of haemostatic powder was sprayed on the surface of the joint cavity and soft tissue before the incision was sutured. Tourniquet pressure in the tourniquet group was the patient's own arterial systolic pressure + 100 mmHg (1 mmHg = 0.133 kPa); the wound was closed, and the tourniquet was loosened with standard dressing. Operation of the non‐haemostatic group was the same as above, but the anaesthetist reduced basal blood pressure by 30 to 40 mmHg during the period from osteotomy to the bone cement‐covered bone bed to reduce bleeding and found that the active bleeding point was electrocoagulated in time. All patients had no drainage in the incision [6]. Low‐molecular‐weight heparin calcium and plantar pump were routinely used postoperatively for anti‐deep vein thrombosis. The wound dressing was replaced when it was oozing out or when the dressing of the incision was slightly tight to prevent distal blood flow. The knee joint was not passively exercised after CPM, and the affected limb was lifted higher than the heart plane

Outcomes

1. Hb and haematocrit (HCT) values: all patients were treated with blood tests 24 hours after surgery; patients with haemoglobin values ​​< 90 g/L were treated with blood transfusion. The number of transfused patients in the 2 groups was recorded

2. Surgical time: record operating time from cutting the skin to suturing the skin measured in minutes

3. Intraoperative blood loss (IBL): calculation of intraoperative blood loss includes liquid in the aspirator bottle minus flushing fluid used in the procedure, plus net weight of the gauze pad

4. Postoperative wound blood loss (PWBL): postoperative blood loss is mainly the increase in net weight after the dressing is weighted; the amount of wound exudation is obtained and converted into volume. Exudate in the dressing has a certain volatilisation before the dressing change, so there is a certain error between the calculated amount of exudation and the actual amount. To minimise errors caused by volatilisation, we have increased the thickness of the dressing and increased the frequency of dressing changes

5. Total measured blood loss (TMBL): IBL + PWBL

6. Periarticular circumference and contusion: the circumference of the knee was measured on the 3rd and 14th days after surgery, and the increase in rate compared with preoperative rate was calculated. The maximum extent of soft tissue plaque around the joint was measured, and the percentage of surface area of ​​the plaque was calculated by the palm method

7. Pain: patients were routinely given analgesia after surgery, intramuscular injection of morphine 10 mg within 6 hours after surgery, oral celecoxib 200 mg twice daily. If the patient feels unbearable pain after the operation, the morphine 10 mg intramuscular injection is given at any time on the premise of ensuring safety of the anaesthetic. Postoperative anaesthetic use was compared between the 2 groups. The patient's femoral pain was recorded and pain scores were obtained on 6th, 24th, 48th, and 7th postoperative days on a 10‐degree scale. The number of patients with straight leg elevations at 24 hours and 7 days after operation was observed and recorded. The maximum angle of spontaneous flexion of the knee joints at 1, 3, and 7 days after surgery was recorded

8. Adverse events included deep vein thrombosis

Identification

Contact information: 200003 Shanghai, Changzheng Hospital, Second Military Medical University, Department of Orthopedics

Corresponding author: Qian Qi Rong, qianqr @ 163. corn

No funding mentioned for this study

Notes

Country: China

Language: Chinese

Study author contacted: yes, no reply from study author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: none stated or identified

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: pain, adverse events

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: change in haemoglobin and haematocrit, duration of surgery, blood loss, periarticular circumference

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 14 days

Study design: single‐centre randomised controlled trial

Participants

80 participants in total

Male:Female: 11:29; 13:27

Age, years (SD): 71 (6); 70 (7)

BMI (SD): 27.3 (6.3); 26.8 (5.1)

Inclusion criteria: patients with primary osteoarthritis or rheumatoid arthritis undergoing primary total knee replacement

Exclusion criteria: bilateral total knee replacement either simultaneously or staged at less than 3‐month intervals, diabetes, haemostatic defect, history of peripheral vascular disease, presence of malignant tumour, preoperative level of Hb < 10 g/L, previous thromboembolism

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 40)

Group B: surgery performed without a tourniquet (n = 40)

All procedures were performed by 4 similar staff surgeons. The implant used was the type of posterior cruciate ligament substituting total knee prosthetic components (Genesis II, Smith & Nephew, Memphis, TN, USA). In group A, the tourniquet was inflated to 100 mmHg above systolic blood pressure after the leg was elevated and exsanguinated, and deflation was performed after the wound was closed and the compressive dressing applied. The tourniquet was not used in group B, and active bleeding points were promptly sealed with electrical coagulation. A uniform perioperative regimen was used in all cases. Antibiotic treatment with second‐generation cephalosporin was infused intravenously (1 dose preoperatively and for the next 2 days). The quantity of saline transfused intravenously within 24 hours postoperatively was 2500 to 3000 mL

Outcomes

1. Postoperative range of motion: measured in degrees of active knee flexion. Assessed at days 1, 3, and 7

2. Number of people conducting self‐leg raise: measured at days 1, 3, and 7

3. Circumference length of the knee: on postoperative days 3 and 14, the circumference length of the knee was measured through the superior patellar pole, and the increased rate compared with the preoperative result was calculated

4. Duration of surgery

5. Intraoperative blood loss: assessed by adding the volume in suction bottles after reduction of wound irrigation fluid and the net blood weight of sponges used during the procedure

6. Postoperative blood loss: soaked dressings were weighed and converted to volume. Due to evaporation from soaked dressings before changing, there was an error between calculated volume and actual volume. So we increased the thickness of the dressings and the frequency of changing

7. Total blood loss: measurement of overall blood loss in millimetres

Identification

Contact details: B Li: H Wu; Q Qian; X Lin; H Zhao, Department of Orthopaedic Surgery, Arthritis Institute, Changzheng Hospital, Second Military Medical University, Shanghai 200003, People’s Republic of China, [email protected]

Notes

Country: China

Language: English

Study author contacted: yes, no reply from study author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: none stated or identified

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number list was used

Allocation concealment (selection bias)

High risk

Open random allocation schedule

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: number of people conducting straight leg raise

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: range of motion, circumference of knee, duration of surgery, intraoperative blood loss, postoperative blood loss, total blood loss

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 12 months

Study design: single‐centre randomised controlled trial

Participants

20 participants in total

Male:Female: 7:3; 9:1

Age, years (SD): 67; 70

BMI (SD): 25.6; 27.1

Inclusion criteria: patients undergoing total knee replacement for osteoarthritis

Exclusion criteria: patients with symptomatic peripheral vascular disease or contraindication to tourniquet use

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 10)

Group B: surgery performed without a tourniquet (n = 10)

All patients underwent TKA by the senior surgeon (Liu) through a standardised technique and prosthesis. All patients received a general anaesthetic without regional blocks or local anaesthesia, in an effort to minimise confounding variables that may influence pain scores. A medial parapatellar approach was used with eversion of the patella. An intra‐articular drain on low suction was inserted before wound closure and was removed day 1 postoperatively. All patients received patient‐controlled analgesia with morphine sulphate for the first 24 hours. Patients were mobilised day 1 postoperatively and were discharged home when mobilising safely. The same standardised physiotherapy protocol was undertaken in all patients postoperatively. Active and passive range of motion was encouraged without the use of continuous passive motion

Outcomes

1. Pain: a score from 1 to 10 was recorded 4 times daily up to discharge and was averaged for each day. Pain scores were recorded at 600, 1200, 1800, and 2200 with the patient at rest for 5 consecutive days. These times coincided with the timing of routine panadol administration by the nurses

2. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

3. Thigh and knee swelling: thigh and knee swelling was recorded with use of a tape measure at the midpoint of the patella and 10 cm above the superior pole of the patella

4. Length of hospital stay: measured in days

5. Range of motion: measured as range of flexion

6. Oxford Knee Score: 12‐item patient‐reported outcome measure used to report outcomes following knee replacement. Scores range from 0 to 60. 0 indicates extreme knee problems, and 60 indicates a normal knee. Not stated when OKS was collected

7. Quadriceps function: measured during active knee extension against gravity using surface EMG. Surface EMG data were recorded (Pocket EMG; BTS S.p.A., Milano, Italy) for each participant on the day of surgery preoperatively, and at 6 weeks and 6 and 12 months postoperatively. The vastus medialis, rectus femoris, and vastus lateralis muscles for both treated and control knees were recorded. Surface EMG electrodes (3M Red Dot; 3M Australia, Sydney, Australia) were placed on the skin surface of the muscle

8. Cement penetration: measured on the femur and tibia as the depth in centimetres the cement penetrates

Identification

Contact details: David Liu, FRACS Gold Coast Centre for Bone and Joint Surgery, John Flynn Private Hospital, Suite 8A, Fred McKay House, 42 Inland Dr, Tugun Queensland 4224, Australia

Tel: +61‐7‐5598‐0205, fax: +61‐7‐5598‐0205, [email protected]

Smith & Nephew Australia provided financial support

Notes

Country: Australia

Language: English

Study author contacted: yes, no reply from study author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: Smith & Nephew Australia provided financial support

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; insufficient information on whether surgeons were blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: pain, OKS

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 12 months

Study design: single‐centre randomised controlled trial

Participants

56 participants in total

Male:Female: 16:36

Age, years (SD): 67 (8)

BMI (SD): 28.1 (5.5)

Inclusion criteria: bilateral severe osteoarthritis with pain, accompanied with or without significant deformity, failure of conservative treatment

Exclusion criteria: recent or current knee sepsis, extensor mechanism discontinuity or severe dysfunction, age > 70 years, coagulation disorder or treatment with drugs known to influence coagulation, diabetes, renal or liver disease, severe cardiovascular problems, lung disease, neurological disorders, cancer

Duration of illness: unspecified

Interventions

Patients undergoing bilateral knee replacement surgery

Group A: surgery performed with a tourniquet (n = 56)

Group B: surgery performed without a tourniquet (n = 56)

The tourniquet was applied on a layer of cotton wool padding applied over the thigh. Both right and left thighs were prepared with a tourniquet before surgery; only the limb of the TG side was elevated and exsanguinated with a rubber limb Eschmarch’s bandage. The tourniquet was then inflated to pressure of 125 mmHg above systolic blood pressure (SBP) just before the incision. Longitudinal incisions were made at the midline with the knee positioned in 90 degrees flexion, from 4 cm proximal to the upper end of the patella up to the tibial tuberosity. The tourniquet was inflated for less than 120 minutes until wound closure was done and compressive dressing was applied. For NG knees, SBP was maintained at a level of approximately 100 mmHg at the time of cementation with antihypertensive drugs. Posterior stabilised knee prostheses (26 GENESIS II, Smith & Nephew, Memphis, TN, USA; 26 Vanguard, Biomet, Warsaw, IN, USA) were used in the surgery. Periarticular injection of ropivacaine (200 mg), adrenaline hydrochloride (0.1 mg), and morphine (5 mg) was administered just before skin closure

Intravenous patient‐controlled analgesia (PCA) with morphine was started postoperatively. All patients received rivaroxaban (10 mg once a day) from the first postoperative day, for 2 weeks, as prophylaxis against thromboembolic complications

Outcomes

1. Duration of surgery: length of every knee procedure from skin incision to wound closure

2. Pain score: pain scores were measured on a visual analogue scale (VAS) of 0 to 10 preoperatively and on postoperative days 1, 3, 5, 7, 14, and 30

3. Range of motion: ROM was measured with a standard handheld goniometer preoperatively and on postoperative days 7, 14, 30, and 90. Its centre of rotation was placed in line with the centre of the knee, the fixed arm of the goniometer aligned with the greater trochanter, and the mobile arm aligned with the lateral malleolus

4. Time to straight leg raise: the time in days to achieve the first straight leg raise of each leg was recorded

5. Swelling: this was assessed from the change in suprapatellar girth (cm). With the knee fully extended, suprapatellar girth was measured with a standard tape measure at the superior margin of the patella preoperatively and on postoperative days 3, 7, 14, and 30

6. Wound healing: postoperatively, the surgical wound was examined for wound length, ooze, soakage, erythema, skin blister, and ecchymosis

7. Deep vein thrombosis: in case of any suspicion of DVT on clinical grounds, a duplex sonography was performed for confirmation of VTE

8. Knee Society Score: knee scoring system developed to evaluate patients post total knee replacement surgery. Consists of a knee score and a functional score. Score ranges from 0 to 100; a score < 60 indicates poor knee function, and a score of 80 to 100 indicates excellent knee function

Identification

Contact details: Pei‐lai Liu, PhD, Department of Orthopaedics, Qilu Hospital, Shandong University, 107 Wenhua West Road, Jinan, China 250012

Tel: 0086‐531‐82166542; fax: 0086‐531‐86927544; [email protected]

No source of funding for this study identified

Notes

Country: China

Language: English

Study author contacted: no

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no source of funding identified for this study

Adverse events:

In the tourniquet group: 4 knees had symptomatic DVT

In the non‐tourniquet group: 4 knees had symptomatic DVT

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Surgeon not blinded ‐ always performed the non‐tourniquet side first; not stated if patients blinded

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: duration of surgery, range of motion, swelling, wound healing

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 12 months

Study design: single‐centre randomised controlled trial

Participants

26 participants in total

Male:Female: 8:18

Age, years (SD): 65.8 (9.2)

BMI (SD): 28.2 (5.6)

Inclusion criteria: patients undergoing bilateral total knee replacement surgery

Exclusion criteria: history of coagulation disorder or medications likely to influence coagulation; diabetes; renal or liver disease; severe cardiovascular problems and lung disease; nerve disorder; cancer; skin disease; history of a previous surgical procedure of the knee other than arthroscopy; apparent keloid constitution

Duration of illness: unspecified

Interventions

Patients undergoing bilateral knee replacement surgery

Group A: surgery performed with a tourniquet (n = 26)

Group B: surgery performed without a tourniquet (n = 26)

As per the surgeon’s usual practice, TKA with or without tourniquet placement was first completed on the left knee, then was performed on the right side after closure. All surgeries were performed under general anaesthesia by the same team of surgeons. A layer of cotton wool padding was applied over both thighs, above which the tourniquet was applied. The tourniquet size was 105 cm × 7 cm. Further, the lower limb on the side assigned to the TP group was elevated, and a rubber limb exsanguinator was inflated to pressure of 125 mmHg above systolic blood pressure immediately before the incision was made. Intravenous morphine for patient‐controlled analgesia (PCA) was started postoperatively. All patients received rivaroxaban (10 mg 2 times daily) for 2 weeks from the first day of the operation as prophylaxis against thromboembolic complications

Outcomes

1. Duration of surgery: was recorded from when the incision was made until it was closed. Measured in minutes

2. Wound healing: measured as oozing that was classified as severe if the gauze was completely soaked or more than 10 layers of the gauze dressing were soaked with blood or serous fluid. Oozing was classified as non‐severe if fewer than 10 layers of sterile absorbent gauze were stained by serous fluid or blood. All wounds were evaluated on postoperative day 2

3. Mean change in suprapatellar girth: measured in terms of change in suprapatellar girth (postoperative girth ‐ preoperative girth, cm). Measurement was made at the superior margin of the patella with the knee at extension as far as possible by using a standard tape; differences between preoperative measurements and measurements obtained on postoperative days 3, 7, 14, and 30 were calculated

4. Range of motion: measured with a standard handheld goniometer preoperatively and on postoperative days 7, 14, 30, and 90. The centre of rotation was set in line with the centre of the knee, while the fixed arm was aligned with the greater trochanter and the mobile arm was aligned with the lateral malleolus

5. Wound length: measured in centimetres with the knee in extension as far as possible on postoperative day 2 while the dressing was changed after the drain was pulled out

6. Revision rate: indicating the number of patients in each group requiring revision surgery up to 1 year postoperatively

7. MSS score: was used for an objective evaluation of the aesthetic appearance of the scar at the end of postoperative year 1. MSS encompasses several factors, including colour, appearance, contour, distortion, and texture of the scar. All these parameters are graded on a scale of 1 to 4 points, except the last one, which is rated as 1 for matte and 2 for shiny appearance. In addition, the overall appearance of the incision scar was evaluated via a visual analogue scale (VAS), with a score of 0 indicating an excellent outcome and 10 indicating the worst possible outcome

Identification

Contact details: Pei‐lai Liu, PhD, Department of Orthopaedics, Qilu Hospital, Shandong University, 107 Wenhua West Road, Jinan, China 250012

Tel: 0086‐531‐82166542; fax: 0086‐531‐86927544; [email protected]

Notes

Country: China

Language: English

Study author contacted: yes, no reply from study author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no source of funding identified for this study

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: duration of surgery, wound healing, mean change in suprapatellar girth, range of motion, wound length, revision rate, MSS score Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 48 hours

Study design: single‐centre randomised controlled trial

Participants

20 participants in total

Male:Female: 2:8; 3:7

Age, years (range): 72.4 (64 to 83); 76.6 (65 to 84)

BMI (range): 28.3 (19.3 to 35.5); 29.5 (24 to 43.8)

Inclusion criteria: patients listed for primary total knee replacement surgery

Exclusion criteria: diabetes mellitus, presence of peripheral arterial occlusive disease (pAOD) or cardiopulmonary diseases ruled out by clinical examination and if necessary duplex ultrasound, medical history of thrombosis or embolism and renal insufficiency (creatinine mmol/L). Patients with severe varus or valgus deformity > 15" or flexion contracture > 20" were excluded from the study to minimise bias due to different soft tissue trauma by preparation and postoperative tension of the skin

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 10)

Group B: surgery performed without a tourniquet (n = 10)

In all cases, a cemented PFC Sigma total knee replacement (DePuy, Warsaw, IN, USA) without resurfacing of the patella was implanted by the same surgeon (GM) through a midline incision and a medial parapatellar approach

Outcomes

1. Postoperative endothelin‐1 measurement: blood was taken preoperatively (2 mL in EDTA tube). 10 further determinations were made at time points 5, 15, and 30 minutes, and 1, 2, 3, 4, 6, 24, and 48 hours after the end of surgery or opening of the tourniquet. Blood samples were centrifuged for l0 minutes at 40°F and 2000 G within a half‐hour of sampling and were frozen at ‐4°F until determination

2. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

3. Duration of surgery: measured in minutes

4. Change in haemoglobin: change in haemoglobin concentration between preoperative reading and first postoperative day reading

5. Change in C‐reactive protein (CRP): change in blood CRP reading between preoperative reading and first postoperative day reading

6. Range of motion: number of degrees of knee flexion achieved preoperatively and on the day of discharge

7. Revision rate

8. Nerve injury

Identification

Contact information: G Matziolis, Centre for Musculoskeletal Surgery, Charite University Hospital, Schumannsir, 20‐21, 10117, Berlin, Germany, [email protected]

Notes

Country: Germany

Language: English

Study author contacted: yes, no reply from study author

Trial registry record or protocol available: none stated or identified

Funding source/declaration of interest: no financial affiliation has been paid by third parties others than the Center for Musculoskeletal Surgery of the Charite University Hospital

Adverse events:

In the tourniquet group: 1 patient had a wound healing disorder that required revision surgery

In the non‐tourniquet group: 1 patient had nerve injury

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

High risk

Open random allocation schedule

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants blinded; insufficient information to specify if surgeons were blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcome: nerve injury

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 2 years

Study design: single‐centre randomised controlled trial

Participants

60 participants in total

Male:Female: 16:14; 16:14

Age, years (SD): 70 (7); 67 (9)

BMI (SD): 28 (3); 28 (3)

Inclusion criteria: patients suffering exclusively from OA, stages II to V; patients requiring knee prosthesis suitable for the use of a triathlon knee system; patients understanding the conditions of the study and willing and able to comply with scheduled postoperative clinical and radiographic evaluations and prescribed rehabilitation; patients who signed the Ethics Committee approved informed consent form before surgery

Exclusion criteria: previous major knee arthroplasty; significant disabling problems from the muscular‐skeletal system other than the knees; obese patients with obesity severe enough to affect their ability to perform activities of daily living (BMI > 35); patients with active or suspected infection; patients with active malignancy; patients with severe osteoporosis, Paget's disease, renal osteodystrophy; patients immunologically suppressed or receiving steroids in excess of physiological dose requirements; patients with a neuromuscular or neurosensory deficit that would limit their ability to assess performance of the device or that interferes with the patient's ability to limit weight‐bearing or places an extreme load on the implant during the healing period; pregnancy; systemic or metabolic disorders leading to progressive bone deterioration; concurrent illness such as sickle cell anaemia, SLE, or renal disease requiring dialysis

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 30)

Group B: surgery performed without a tourniquet (n = 30)

Each patient was given preoperative antibiotics and tranexamic acid. Surgeries were performed via a midline incision with a parapatellar medial entrance to the joint using appropriate guide instruments according to the surgical technique supplied to the knee system. In both groups, the bony surfaces were prepared in the same manner, were cleansed by saline pulse lavage, and were kept clean of blood by saline‐prepared medical pads. At the time of surgery, 8 tantalum markers (0.8 mm diameter; RSA Biomedical, Umeå, Sweden) were inserted into the proximal tibial metaphysis and 5 markers were inserted into the polyethylene tibial insert. The tourniquet was applied during dressing and was inflated to 300 mmHg just before the start of surgery and was not deflated until the leg was sutured and dressed. The group operated on without the use of a tourniquet was operated on with the same surgical and cementing technique. The cement used was Refobacin® Bone Cement R (Biomet Inc., Warsaw, IN, USA). No patellar components were used in either group. Postoperatively, low‐molecular‐weight heparin was used for thromboembolic prophylaxis. Early full weight‐bearing and mobilisation were similar for both groups

Outcomes

1. Duration of surgery

2. Length of hospital admission

3. Radiostereometric analysis: the RSA investigation was done within 2 to 3 days postoperatively after full weight‐bearing, then at 3 months, 1 year, and 2 years postoperatively. RSA was performed with the patient in a supine position, with the knee of interest inside a calibration cage (Cage 10, RSA Biomedical, Umeå, Sweden). 3D tibial component migration was measured with UmRSA software (v6.0, RSA Biomedical, Umeå, Sweden). The precision of the RSA system according to the double exams was 0.12 mm, 0.21 mm, and 0.14 mm for x‐, y‐, and z‐translations, and 0.12°, 0.11°, and 0.09° for x‐, y‐, and z‐rotations

4. Maximum total point motion: positive directions for translations along the orthogonal axes were transverse (medial to lateral), longitudinal (caudal to cranial), and sagittal (posterior to anterior). Positive directions for rotations about the coordinate axes were anterior tilt (transverse axis), internal rotation (longitudinal axis), and varus (sagittal axis). An increase in MTPM > 0.2 mm between first and second year follow‐up was considered as continuous migration

5. Mortality

6. Deep vein thrombosis

7. Stroke

8. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

Identification

Contact information: Mats Molt, Department of Orthopaedics Hässleholm‐Kristianstad Ystad, Hässleholm, Sjukhusorganisation, Box 351, S‐281, 25 Hässleholm, Sweden

Tel.: +46 451298707, [email protected] (M. Molt)

Notes

Country: Sweden

Language: English

Study author contacted: no

Trial registry record or protocol available: clinical trial ID: NCT01604382

Funding source/declaration of interest: no funding for this study

Adverse events:

In the tourniquet group: 2 patients required re‐operation; 1 patient reported instability in the index knee at 2 years' follow‐up

In the non‐tourniquet group: 1 patient died due to postoperative septicaemia; 1 patient had a stroke; 1 patient had DVT

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 7 days

Study design: single‐centre randomised controlled trial

Participants

103 participants in total

Male:Female: 6:45; 9:43

Age, years (SD): 72.8 (7.3); 74.6 (7.6)

BMI (SD): 27.7 (3.4); 29.2 (3.9)

Inclusion criteria: patients undergoing total knee replacement surgery

Exclusion criteria: patients showing preoperative DVT, coagulation disorder, abnormal coagulation test values, or receiving anticoagulants; patients who received anticoagulant therapy postoperatively according to the judgement of the physician

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 51)

Group B: surgery performed without a tourniquet (n = 52)

All operations were conducted by a single surgeon (S.K.). All patients received spinal and epidural anaesthesia in conjunction with general anaesthesia, and the tube for the epidural continuation was removed on the second postoperative day. Exposure of the knee was through a midline skin incision (approximately 8 to 10 cm) and a mid‐vastus approach. All patients had a Scorpio non‐restrictive geometry posterior‐stabilised system (Stryker Howmedica Osteonics, Allendale, NJ, USA) cemented arthroplasty. An extramedullary guide was used for the tibia, and an intramedullary osteotomy guide was used for the distal cut of the femur. The patella was resurfaced in all patients
In patients of group T, a pneumatic thigh tourniquet was applied, was inflated to pressure of 250 mmHg, then was deflated after skin closure. Elastic stockings were worn postoperatively by all patients. All patients were managed with a foot pump (Kendall SCD 700, Covidien, MA, USA) on both legs to prevent DVT. Walking was permitted from the day after surgery. Two days after the operation, the drain was removed

Outcomes

1. Duration of surgery: measured in minutes

2. Overall blood loss: the amount of intraoperative and postoperative blood loss was measured in all cases based on suction volume and weight of the sponges

3. Deep vein thrombosis: bilateral ultrasonography of the lower extremities (iU22 Vision 2006, Philips, Seattle, WA, USA) was performed by highly skilled physicians. Ultrasonography was scheduled preoperatively and 7 days postoperatively. A thrombus located in anterior tibial vein (ATV), peroneal vein (PeV), soleal vein (SoV), posterior tibial vein (PTV), and very small tertiary vessels was defined as distal DVT. A thrombus located in femoral vein (FV), deep femoral vein (DFV), great saphenous vein (GSV), small saphenous vein (SSV), and popliteal vein (PV) was defined as proximal DVT. Total DVT included distal DVT and/or proximal DVT

4. Pulmonary embolism

Identification

Contact information: Noriaki Mori, Department of Orthopaedic Surgery, Wajo Eniwa Hospital, Koganechuo 2‐1‐1, Eniwa City 061‐1449, Japan

Tel.: +81 123 33 2333; fax: +81 123 335108; [email protected] (N.Mori)

Notes

Country: Japan

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events: no additional adverse events reported in the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Three groups: surgery performed with a tourniquet for the entire procedure; surgery performed with a tourniquet for cementing only; surgery performed without a tourniquet

Follow‐up: 6 weeks

Study design: single‐centre randomised controlled trial

Participants

69 participants in total

Male:Female: not stated

Age, years (range): 65.05 (52 to 81)

BMI (SD): not stated

Inclusion criteria: patients diagnosed with arthritis refractory to conservative treatment and identified as TKA candidates

Exclusion criteria: secondary arthritis, extreme deformity, previous cardiovascular disease

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet for the entire procedure (n = 24)

Group B: surgery performed with a tourniquet for cementing only (n = 20)

Group C: surgery performed without a tourniquet (n = 25)

Posterior cruciate retaining Genesis II (Smith & Nephew, Memphis, TN, USA) cemented knee system and OrCem 3 low‐viscosity polymethylmethacrylate (PMMA) bone cement (European Medical Contract Manufacturing, Nijmegen, Netherlands) were used in all patients. All patients were operated under general anaesthesia with propofol and desfluran

Outcomes

1. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

2. Pain: measured as a VAS score between 0 and 10 at 6 weeks

3. Knee Society score: knee scoring system developed to evaluate patients post total knee replacement surgery. Consists of a knee score and a functional score. Score ranges from 0 to 100; a score < 60 indicates poor knee function, and a score of 80 to 100 indicates excellent knee function

4. Cement penetration depth: measured as the depth in centimetres the cement penetrated the femur and tibia at the 6‐week radiograph

Identification

Contact information: Okan Ozkunt, Department of Orthopedics and Traumatology, Acibadem University Atakent Hospital, Halkali/Kucukcekmece, Istanbul, 34303, Turkey, [email protected]

Notes

Country: Turkey

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events: no additional adverse events reported in the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 4 days

Study design: single‐centre randomised controlled trial

Participants

90 participants in total

Male:Female: 21:24; 11:34

Age, years (range): 69 (47 to 85); 70.5 (50 to 90)

BMI (range): 27.8 (18.5 to 38.1); 26 (18.5 to 33.9)

Inclusion criteria: patients with primary end‐stage osteoarthritis receiving unilateral total knee arthroplasty (TKA)

Exclusion criteria: patients receiving any anticoagulation before surgery (e.g. acetylsalicylic acid, phenprocoumon, warfarin, clopidogrel, dabigatran, rivaroxaban, low‐molecular‐weight heparin) with the diagnosis of liver dysfunction/coagulation dysfunction or a history of peripheral arterial obstructive disease or thromboembolic events

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 45)

Group B: surgery performed without a tourniquet (n = 45)

All patients received a cemented, posterior‐stabilised primary TKA (Nexgen LPS Flex, Zimmer, Warsaw, IN, USA) with a fixed bearing design without patellar resurfacing. A total of 40 g of bone cement (Palacos R®, Heraeus, Hanau, Germany) was used with a fourth‐generation cementing technique including pulsatile lavage, vacuum mixture, double‐cementing technique, and cement gun pressurisation. Every patient received the same standardised postoperative pain medication protocol

Outcomes

1. Pain: measured as a VAS score between 0 and 10 on the second and fourth postoperative days. Pain was measured at rest and on mobilisation

2. Overall blood loss: to determine overall blood loss, peripheral blood was taken preoperatively and on the first postoperative day. Total blood loss was calculated using the method of Bourke and Smith to take both obvious and hidden blood losses into account

3. Cement mantle thickness: measured as the depth in centimetres the cement penetrated the femur and tibia at the day 4 radiograph

Identification

Contact information: T Pfitzner, P von Roth, C Perka, Orthopaedic Department, Center for Musculoskeletal Surgery, Charité – Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany, [email protected]

Notes

Country: Germany

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events: no additional adverse events reported in the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 4 days

Study design: single‐centre randomised controlled trial

Participants

72 participants in total

Male:Female: 9:27; 8:28

Age, years (SD): 72.1 (6.9); 71.5 (6.8)

BMI (SD): 28.6 (4.5); 27.9 (4.2)

Inclusion criteria: patients undergoing total knee replacement surgery for osteoarthritis

Exclusion criteria: rheumatoid arthritis, coagulopathy, uncontrolled hypertension, peripheral vascular disease

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 36)

Group B: surgery performed without a tourniquet (n = 36)

All patients underwent primary total knee arthroplasty with minimally invasive techniques and cemented prostheses (Genesis II Total Knee System, Smith & Nephew, Memphis, TN, USA; or U2 Knee System, United Orthopedic, Taipei, Taiwan). All operations were performed through the medial parapatellar approach by experienced knee surgeons. An intramedullary guide was used for both tibial and femoral cuts. No drainage system was used postoperatively for any patient
In the tourniquet group, the tourniquet was inflated to systolic blood pressure plus 100 mmHg and was released after the joint capsule had been closed. A 40‐mL local anaesthetic mixture (2% Iidocaine with epinephrine, bupivacaine, and gentamicin) was injected into the joint space for pain control and as a temporary tamponade. The wound was closed after wound irrigation and haemostasis and then was wrapped with elastic bandages. In the non‐tourniquet group, the tourniquet was wrapped around the thigh but was not inflated during surgery

Outcomes

1. Intraoperative blood loss: measured by weighing sponges and measuring suction volume

2. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

3. Overall blood loss: calculated by multiplying estimated blood loss by the decrease in haematocrit

4. Change in haemoglobin: repeated blood tests were performed daily from days 1 to 4. The haemoglobin concentration in the blood was recorded each day

5. Change in haematocrit: repeated blood tests were performed daily from days 1 to 4. The haematocrit concentration in the blood was recorded on each day

6. Serum creatine phosphokinase, myoglobin, lactate dehydrogenase, C‐reactive protein: blood tests were performed daily from days 1 to 4 postoperatively. Concentrations of these enzymes was re‐scored at each time point

7. Pain: measured on a VAS score between 0 and 10 on days 1 and 4 postoperatively

8. Duration of surgery: measured in minutes

Identification

Contact information: Ta‐Wei Tai, Department of Orthopaedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan

No funding for this study

Notes

Country: Taiwan

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events: no additional adverse events reported in the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcome: pain

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: intraoperative blood loss; overall blood loss; blood transfusion rate; change in haemoglobin; change in haematocrit, serum creatinine phosphokinase, myoglobin, lactate dehydrogenase, CRP, duration of surgery

Outcome assessors blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 10 days

Study design: single‐centre randomised controlled trial

Participants

63 participants in total

Male:Female: 15:18; 11:19

Age, years (SD): 69.8 (6.7); 69.8 (9.0)

BMI (SD): 28.6 (4.5); 27.9 (4.2)

Inclusion criteria: patients undergoing total knee replacement for osteoarthritis or rheumatoid arthritis

Exclusion criteria: bilateral TKA required simultaneously or staged at less than 3‐month intervals; history of bleeding diathesis; revision TKA; history of musculoskeletal infection of the affected limb; history of peripheral vascular disease

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 33)

Group B: surgery performed without a tourniquet (n = 30)

Groups were similar with respect to operative procedure. Lateral release was performed in 22 patients in the tourniquet group and in 20 in the non‐tourniquet group (Table 1). One synovectomy was performed in each group. All patients received a primary cemented total knee replacement with a cemented polyethylene patellar replacement. In the tourniquet group, the leg was elevated and exsanguinated (without use of an Esmarch bandage) before tourniquet inflation. The tourniquet was set at 125 to 150 mmHg above systolic blood pressure, up to a maximum value of 300 mmHg. The tourniquet was deflated after the bone cement had set, and only then was electrocautery used for haemostasis. In the non‐tourniquet group, electrocautery was used as necessary throughout the procedure

Outcomes

1. Intraoperative blood loss: recorded by the anaesthetist by method estimation (i.e. suction drainage ‐ irrigation volume (soaked sponges were considered equivalent to 80 mL of blood))

2. Blood transfusion rate: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

3. Duration of surgery: measured in minutes

4. Deep vein thrombosis

5. Infection

6. Haemaglobin level: blood haemoglobin was collected on postoperative days 1, 2, 3, 5, and 7

7. Postoperative blood loss: recorded in terms of suction volume at 36 hours after the operation

8. Overall blood loss: measures by the sum of intraoperative blood loss and postoperative drainage volume

Identification

Contact information: Dr John F Rudan, Department of Surgery, Queen's University, Kingston ON K7L 3N6

Fax 613 549‐2529, [email protected]

Notes

Country: Kingston

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events:

In the tourniquet group: 4 wound infections

In the non‐tourniquet group: 1 wound infection, 1 gastrointestinal haemorrhage

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients 'blindly' randomised; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: DVT, infection

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

High risk

Assessor‐reported outcomes:intraoperative blood loss, blood transfusion rate, duration of surgery, haemoglobin level, postoperative blood loss, overall blood loss Outcome assessors were not blinded; therefore high risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of blinding identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 3 months

Study design: single‐centre randomised controlled trial

Participants

80 participants in total

Male:Female: 9:31; 16:24

Age, years (range): 73.65 (52 to 110); 80.25 (50 to 110)

BMI (SD): not reported

Inclusion criteria: patients undergoing primary total knee replacement surgery for osteoarthritis

Exclusion criteria: patients with diabetes, haemostasis defect, rheumatoid arthritis, previous thromboembolism, abnormal vascular supply to the leg, previous open knee surgery, bilateral TKA

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 40)

Group B: surgery performed without a tourniquet (n = 40)

All operations were performed under general anaesthesia by a single surgeon or by house staff using a standardised technique. Cefamandol 1500 mg was given intravenously at induction of anaesthesia, and 4 further doses of 750 mg were given postoperatively. Standard anticoagulant prophylaxis using enoxaparin was started the evening before surgery and continued until the patient was fully mobile. In group A, the limb was first exsanguinated by elevation for 2 minutes, then the tourniquet was inflated to 350 mmHg. If the duration of tourniquet use exceeded 90 minutes, the tourniquet was released intraoperatively and haemostasis was completed. After 10 minutes of release, a new exsanguination was instituted. The tourniquet was not released until after the wound was closed and the compressive dressing was applied

Outcomes

1. Duration of surgery: measured in minutes

2. Change in haemoglobin: blood concentrations recorded preoperatively and on first and tenth days postoperatively

3. Change in haematocrit: blood concentrations recorded preoperatively and on first and tenth days postoperatively

4. Overall blood loss: was calculated as the sum of compensated and non‐compensated blood loss. Blood concentrations were recorded preoperatively and on first and tenth days postoperatively

5. Thigh pain: study authors did not include data on pain scores in the final report. They stated that pain scores were significantly lower in the control group when compared to the tourniquet group

6. Wound complications

7. Implant loosening: radiographic analysis was conducted at 3 months to look for lucency ‐ a sign of loosening

8. Time to achieve straight leg raise

9. Range of knee flexion: measured in degrees at days 5 and 10 and at 3 months

Identification

Contact information: E Vandenbussche, L‐D Duranthon, B Augereau, Department of Orthopaedic Surgery, Hôpital Européen Georges Pompidou, 20 Rue Louis Blanc, 75908 Paris Cedex 15, France, [email protected]‐hop‐paris.fr

Notes

Country: France

Language: English

Study author contacted: yes, no reply from author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events:

In the tourniquet group: 1 patient had DVT

In the non‐tourniquet group: 2 patients had DVT

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Patients blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: pain, complications, time to achieve straight leg raise

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: duration of surgery, change in haemoglobin, change in haematocrit, overall blood loss, implant loosening, range of knee flexion

Outcome assessors were blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 2 days

Study design: single‐centre randomised controlled trial

Participants

40 participants in total

Male:Female: 10:10; 11:9

Age, years (SD): 67.85 (6.91); 65.65 (8.54)

BMI (SD): 30.43 (5.07); 31 (5.31)

Inclusion criteria: Patients with end stage knee osteoarthritis who have failed non‐operative management and are being listed for a primary total knee replacement.

Exclusion criteria: history of peripheral vascular disease that precluded tourniquet use or required a semi‐constrained prosthesis due to ligament instability necessitating a fixed bearing tibial component with tibial stem

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 20)

Group B: surgery performed without a tourniquet (n = 20)

In both groups, the knee replacement procedure was commenced with a tourniquet applied but without inflation. The patient’s blood pressure was maintained hypotensive if no contraindications were applied, else normotensive. Proximal tibial osteotomy was undertaken via a computerised navigation system, with all resections at 90 to the tibial long axis, removing a planned 10‐mm resection of the lateral tibial plateau. After bone resection and preparation were undertaken, patients were randomised to group A or B. In group A, the leg was elevated for 1 minutes, then the tourniquet was inflated to 300 mmHg for the duration of the cementing procedure. In group B, the tourniquet was not inflated

Outcomes

1. Cement penetration depth: distance in millimetres the cement penetrated the femur and the tibia on the postoperative radiograph. This was assessed on day 2

Identification

Contact information: Christopher John Vertullo, Orthopaedic Surgery & Sports Medicine Centre, 8‐10 Carrara Street, Benowa, QLD, Australia, [email protected]

Notes

Country: France

Language: English

Study author contacted: no

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events: no adverse events reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Low risk

Assessor‐reported outcomes: cement penetration depth

Outcome assessors were blinded; therefore low risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 4 months

Study design: single‐centre randomised controlled trial

Participants

77 participants in total

Male:Female: 11:26; 14:26

Age, years (range): 72.5 (57 to 85); 71.8 (43 to 91)

BMI (SD): not reported

Inclusion criteria: patients undergoing primary total knee arthroplasty

Exclusion criteria: patients with diabetes, rheumatoid arthritis, previous thromboembolism, active malignancy, those having 1‐stage bilateral surgery

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 37)

Group B: surgery performed without a tourniquet (n = 40)

All patients had identical anaesthesia, which included premedication with temazepam and general anaesthesia with fentanyl. No patient had spinal or epidural anaesthesia Postoperatively, all had ‘patient‐controlled analgesia’ (PCA) with an infusion of morphine sulphate. All patients received intravenous cefuroxime (1.5 g) after induction of anaesthesia and twice postoperatively. Those in group A had TKA under a tourniquet after the leg had been exsanguinated. Tourniquet pressure was twice the systolic blood pressure. Patients in group B did not have a tourniquet applied to the leg. Low‐dose warfarin was given to maintain the international normalised ratio between 1.3 and 2.0, and was continued until discharge from the hospital. Mobilisation began on removal of the drains, 48 hours after the operation

Outcomes

1. Pain: assessed as a visual analogue scale between 0 and 10; zero indicates no pain, and 10 indicates extreme pain. Measured on week 1, on week 6, and at 4 months. Study authors did not report raw data, instead reporting a change in pain score

2. Change in knee flexion: measured in degrees. The number of degrees the knee can flex at week 1, week 6, and 4 months

3. Change in swelling of the thigh, knee, and calf: the circumference of the limb at the level of the superior pole of the patella and at points 10 cm above and below. Measured at week 1, week 6, and 4 months

4. Deep vein thrombosis

5. Adverse events

Identification

Contact information: JC D’Arcy, FRCS, Consultant Orthopaedic Surgeon, Department of Orthopaedics, Eastbourne District General Hospital, King’s Drive, Eastbourne, East Sussex BN21 2UD, UK

Notes

Country: UK

Language: English

Study author contacted: no

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study

Adverse events:

In the tourniquet group: 6 patients required manipulation under anaesthesia, 1 patient had wound leakage, 1 patient died from unrelated causes

In the non‐tourniquet group: 5 patients required manipulation under anaesthesia, 2 patients died from unrelated causes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 4 weeks

Study design: single‐centre randomised controlled trial

Participants

37 participants in total

Male:Female: not reported

Age, years (SD): 63.2 (8.7); 61.4 (7.4)

BMI (SD): not reported

Inclusion criteria: patients undergoing primary total knee replacement surgery

Duration of illness: unspecified

Interventions

All patients under general anaesthesia using sevoflurane and propofol. Endotracheal intubation and mechanical ventilation were employed to maintain a constant end‐tidal CO₂ level. The fractional inspired O₂ concentration (33%) did not change during the operation. In the with tourniquet group, a tourniquet was applied at approximately 100 mmHg above systolic blood pressure. The operations were performed with autologous blood transfusion and used a postoperative blood conservation system. Blood losses in the 2 groups were measured and compared. Heparin at 5000 U/d was postoperatively administered to all patients for 3 weeks

Outcomes

1. Overall blood loss: measured in millilitres

2. Postoperative blood loss: measured in millilitres using a postoperative drainage catheter

3. Deep vein thrombosis

4. Pulmonary embolism

5. Number of embolic events: measured via ultrasound. To identify the residue, it was Sudan‐stained to detect fat, and it was Giemsa‐stained to detect thrombus and bone marrow. Echogenic materials were graded as follows: Grade 0 no emboli, Grade 1 few fine emboli, Grade 2 a cascade of fine emboli or embolic masses < 5 mm, Grade 3 fine emboli mixed with large embolic masses > 5 mm

Identification

Contact information: N Kato, R Ogawa, Department of Anesthesiology, Nippon Medical School, 1‐1‐5 Sendagi, Bunkyo‐ku, Tokyo, Japan

Notes

Country: Japan

Language: English

Study author contacted: no

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no funding for this study reported

Adverse events:

In the tourniquet group: 1 patient had PE and 2 patients had DVT

In the non‐tourniquet group: 0 patients had PE or DVT

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 6 months

Study design: single‐centre randomised controlled trial

Participants

100 participants in total

Male:Female: 22:28; 19:31

Age, years (SD): 67.58 (4.61); 68.06 (3.16)

BMI (SD): 24.10 (2.16); 23.87 (2.13)

Inclusion criteria: patients undergoing primary total knee replacement surgery for osteoarthritis

Exclusion criteria: patients < 18 years or > 85 years of age, rheumatoid arthritis, allergy to TXA, history of thrombosis, coagulation dysfunction, uncontrolled hypertension, infection, body mass index (BMI) > 35

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 50)

Group B: surgery performed without a tourniquet (n = 50)

All patients were treated intravenously with 15 mg/kg TXA 10 minutes before skin incision; an additional 1 g TXA was used after 3 hours. All patients were treated by a senior orthopaedic surgeon under general anaesthesia. Drainage tubes were used in all patients and were removed 24 hours postoperatively if blood loss was < 300 mL. Otherwise, they continued to be used until the quantity was < 50 mL

Outcomes

1. Total blood loss: in millilitres estimated using the formula of Gross et al

2. Intraoperative blood loss: measured in millilitres. The higher the score, the worse the outcome

3. Hidden blood loss: measured in millilitres. The higher the score, the worse the outcome

4. Drainage volume: measured in millilitres. The higher the score, the worse the outcome

5. Transfusion requirements: defined as the number of units delivered to the patient. The higher the number of units, the worse the outcome

6. Maximum Hb drop: defined as the difference between preoperative Hb level and lowest postoperative Hb level received during hospital stay and the lowest Hb level before any blood transfusion

7. Knee circumference: the circumference of the limb at the level of the superior pole of the patella and at points 10 cm above and below. Measured on postoperative days 1, 3, and 5, and at 6 months

8. Pain: measured on a visual analogue score between 0 and 10

9. ROM: number of degrees of knee flexion. Measured on postoperative days 1, 3, and 5, and at 1 and 6 months

10. Postoperative hospital stay

11. Deep vein thrombosis (DVT) and/or pulmonary embolism (PE) events

12. Wound‐related complications as second outcomes

Identification

Contact information: Yuangang Wu, Department of Orthopaedics, West China Hospital, Sichuan University, 37 # Guoxue Road, Chengdu, 610041, People's Republic of China, [email protected]

Notes

Country: China

Language: English

Study author contacted: no

Trial registry record or protocol available: researchregistry4423

Funding source/declaration of interest: study was funded by the Science and Technology Department of Sichuan Province (2017FZ0056 and No. 2018HH0141), and also by the Health Department of Sichuan Province (N0. 18ZD016)

Adverse events: no adverse events reported between the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded; surgeons not blinded

However surgeons would be able to influence/alter their performance only for intraoperative outcomes such as intraoperative blood loss, operative time, or quality of cementation. It is unlikely that surgeons would alter their performance to influence these outcomes for fear of damaging the overall quality and safety of the surgery

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: pain, DVT, wound‐related complications

Patients blinded; therefore low risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

High risk

Assessor‐reported outcomes: total blood loss, intraoperative blood loss, hidden blood loss, drainage volume, transfusion requirements, maximum Hb drop, knee circumference, range of motion, length of stay

Outcome assessors not blinded; therefore high risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All outcome measures reported

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Three groups: surgery performed with a tourniquet inflated until wound closure; surgery performed with a tourniquet inflated until components were inserted; surgery performed without a tourniquet

Follow‐up: day 1

Study design: single‐centre randomised controlled trial

Participants

84 participants in total

Male:Female: 6:16; 9:24; 7:22

Age, years (range): 68 (54 to 72); 64 (54 to 73); 66 (51 to 74)

BMI (SD): not reported

Inclusion criteria: patients with a diagnosis of severe primary osteoarthritis, insertion of bicompartmental prosthesis, absence of any known coagulation disorder

Exclusion criteria: Patients undergoing a unicondylar knee replacement or a revision knee replacement. Presence of a known coagulation disorder or a patient who is routinely taking anticoagulant medication. 

Duration of illness: unspecified

Interventions

Group 1: surgery performed without a tourniquet (n = 29)

Group 2: surgery performed with a tourniquet inflated until components inserted (n = 33)

Group 3: surgery performed with a tourniquet inflated until wound closure (n = 22)

For all patients, suction drainage was used routinely and was removed after 24 hours. Low‐molecular‐weight heparin was administered to all patients, and no monitoring for INR was performed. Antibiotic prophylaxis was started just before the tourniquet was inflated with 1 g cefazolin, then was continued 3 times daily for 48 hours

Outcomes

1. Change in haemoglobin: difference between preoperative haemoglobin and day 1 postoperative haemoglobin

2. Change in haematocrit: difference between preoperative haematocrit and day 1 postoperative haematocrit

3. Overall blood loss: measured in miilimetres

4. Blood transfusion rate: defined as number of units delivered to the patient. The higher the number of units, the worse the outcome

5. Duration of surgery: measured in minutes

Identification

Contact information: Alireza Yavarika, Department of Orthopaedics, Ward of Orthopaedics, Besat Hospital, Hamadan University of Medical Sciences, Hamadan, Iran, tel +959144122542

Notes

Country: Iran

Language: English

Study author contacted: yes, no reply from study author

Trial registry record or protocol available: none reported or identified

Funding source/ declaration of interest: no source of funding reported or identified

Adverse events: no adverse events reported between the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Low risk

Self‐reported outcomes: none

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: not reported

Study design: single‐centre randomised controlled trial

Participants

60 participants in total

Male:Female: 8:22; 11:19

Age, years (SD): 72 (6); 71 (6)

BMI (SD): 25 (4); 26 (4)

Inclusion criteria: patients undergoing primary total knee replacement surgery for osteoarthritis or rheumatoid arthritis

Exclusion criteria: patients with diabetes, haemorrhagic disease, Hb < 100 g/L, peripheral neurovascular disease, malignant tumour, history of vascular thrombosis, history of infection in the lower limb

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 30)

Group B: surgery performed without a tourniquet (n = 30)

Tourniquet pressure in the tourniquet group was based on the patient’s arterial systolic pressure + 100 mmHg (1 mmHg = 0.133 kPa). The wound was closed and dressed with standard wound dressings and compression before the tourniquet was loosening. Procedures applied in the control group were identical, but between osteotomy and bone cement insertion, the anaesthesiologist controlled blood pressure at 30 to 40 mmHg to reduce bleeding. Intraoperative active bleeding was coagulated electrically. Conventional low‐molecular‐weight heparin and a foot pump were used postoperatively to prevent deep vein thrombosis (DVT)

Outcomes

1. Change in haemoglobin: difference between preoperative haemoglobin and postoperative haemoglobin

2. Change in haematocrit: difference between preoperative haematocrit and postoperative haematocrit

3. Intraoperative blood loss: was calculated as volume of liquid in the suction bottle plus increase in gauze weight minus volume of irrigation fluid used during surgery

4. Postoperative blood loss: was principally recorded as volume of visible wound drainage fluid, including volume of blood transfused 6 hours after surgery

5. Overall blood loss: preoperative patient blood volume (PBV) × (preoperative HCT – postoperative HCT)

6. Adverse events

Identification

Contact information: Dr ZHANG Fu‐jiang, Department of Orthopaedics, Tianjin Hospital, Tianjin 300211, China

No funding for this study

Notes

Country: China

Language: English

Study author contacted: no

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no source of funding reported or identified

Adverse events: no adverse events reported between the 2 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

High risk

Open random allocation schedule

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient reporting of attrition

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: 22 months

Study design: single‐centre randomised controlled trial

Participants

166 participants in total

Male:Female: 12:72; 13:69

Age, years (range): 63.2 (46 to 80); 65.2 (46 to 83)

BMI: 28.1; 28.8

Inclusion criteria: unilateral primary total knee arthroplasty for knee osteoarthritis; volunteers to participate in the study

Exclusion criteria: severe medical disease, peripheral vascular disease or deep venous thrombosis of the lower extremities, abnormal coagulation function, severe internal and external valgus deformity of the knee joint

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 84)

Group B: surgery performed without a tourniquet (n = 82)

Surgery was performed under general anaesthesia (34 cases) or sciatic nerve combined with femoral nerve block anaesthesia (50 cases) in the tourniquet group. Surgery under general anaesthesia (29 cases) or sciatic nerve was combined with femoral nerve block anaesthesia (53 cases) in the non‐tourniquet group. Regular intravenous infusion of antibiotics (cefuroxime or ceftriaxone or vancomycin) from 30 mmn to 48 hours after surgery. Intraoperative routine infusion, ambulation, 2 U autologous blood or suspended red blood cells, fresh frozen plasma, blood transfusion treatment was given when the patient developed anaemia symptoms and Hb was lower than 80 g/L. Oral rivaroxaban 5 mg/d was given to prevent thrombosis within 28 days after surgery; was combined with non‐steroidal and opioid drugs to relieve pain. Drainage tube was removed on the first day after surgery and lower limb function training was started

Outcomes

1. Pain: measured on a visual analogue scale between 0 and 10. VAS scores were used to evaluate knee pain before and 3, 5, 14, and 28 days after surgery

2. Duration of surgery: measured in minutes

3. Intraoperative blood loss: measured in millilitres

4. Deep vein thrombosis

5. Hospital for Special Surgery knee score: knee‐related score assessing pain, stability (measured as total varus‐valgus arc, extension), motion (measured as total passive arc), quadriceps strength (measured as 10% of normal for age and gender), and subtraction for contracture or fixed varus/valgus. Score ranges from 0 to 100. The higher the score, the better the outcome

Identification

Contact information: DONG Jiyuan, [email protected], Department of Orthopaedics, PLA General Hospital, Beijing, 100853

Notes

Country: China

Language: English

Study author contacted: yes, no reply from the author

Trial registry record or protocol available: none reported or identified

Funding source/declaration of interest: no source of funding reported or identified

Adverse events:

In the tourniquet group: 9 patients had DVT

In the non‐tourniquet group: 2 patients had DVT

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment ‐ self‐reported outcomes (detection bias)

Unclear risk

Not stated if patients were blinded; therefore unclear risk of bias

Blinding of outcome assessment ‐ assessor reported outcomes (detection bias)

Unclear risk

Not stated if outcome assessors were blinded; therefore unclear risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

No protocol reported or identified

Other bias

Low risk

No other sources of bias identified

Study characteristics

Methods

Two groups: surgery performed with a tourniquet; surgery performed without a tourniquet

Follow‐up: not reported

Study design: single‐centre randomised controlled trial

Participants

39 participants in total

Male:Female: 7:13; 5:14

Age, years (SD): 63.12 (6.79); 61.89 (7.93)

BMI: not reported

Inclusion criteria: patients undergoing total knee replacement surgery, able to provide informed consent and adhere to the study protocol

Exclusion criteria: patients with a history of deep venous thrombosis of the lower extremities

Duration of illness: unspecified

Interventions

Group A: surgery performed with a tourniquet (n = 20)

Group B: surgery performed without a tourniquet (n = 19)

Outcomes

1. Change in D‐dimer, fibrinogen, plasma viscosity, and antithrombin III: measured in blood concentration before surgery and 5 minutes after surgery

2. Change in haematocrit: measured in blood concentration before surgery and 5 minutes after surgery

3. Pain score: study authors did not mention specific values in the final report. They stated that pain scores were significantly lower in the control group

Identification

Contact information: Zhou Wei, Master attending physician, Department of Orthopaedics, First People's Hospital of Pingdingshan, Pingdingshan 467000, Henan Province, China, [email protected]

No funding for this study

Notes