Tourniquet use for knee replacement surgery

Imran Ahmed; Amit Chawla; Martin Underwood; Andrew J Price; Andrew Metcalfe; Charles Hutchinson; Jane Warwick; Kate Seers; Helen Parsons; Peter DH Wall

doi:10.1002/14651858.CD012874.pub2

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Figure 1

Study flow diagram: search for randomised controlled trials.

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Figure 2

Study flow diagram: search for non‐randomised studies.

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 4

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 1: Pain at different postoperative days (visual analogue scale 0 to 10, lower is better)

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Analysis 1.2

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 2: Function: patient‐reported knee function at 3 months (scale 0 to 100, higher is better)

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Analysis 1.3

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 3: Function: patient‐reported knee function at 12 months (scale 0 to 100, higher is better)

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Analysis 1.4

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 4: Global assessment of success: participant‐reported satisfaction at 3 months (based on number of participants, higher is better)

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Analysis 1.5

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 5: Global assessment of success: participant‐reported satisfaction at 6 months (based on number of participants, higher is better)

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Analysis 1.6

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 6: Health‐related quality of life: SF‐12 mental component at 6 weeks (0 to 100, higher is better)

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Analysis 1.7

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 7: Health‐related quality of life: SF‐12 mental component at 6 months (0 to 100, higher is better)

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Analysis 1.8

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 8: Serious adverse events

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Analysis 1.9

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 9: Serious adverse event: venous thromboembolic event (VTE)

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Analysis 1.10

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 10: Serious adverse event: deep vein thrombosis (DVT)

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Analysis 1.11

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 11: Serious adverse event: pulmonary embolism (PE)

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Analysis 1.12

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 12: Serious adverse event: infection

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Analysis 1.13

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 13: Serious adverse event: re‐operation

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Analysis 1.14

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 14: Survival of the implant: risk of revision up to 2 years

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Analysis 1.15

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 15: Blood loss: postoperative transfusion risk (lower is better)

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Analysis 1.16

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 16: Blood loss: intraoperative (mL, lower is better)

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Analysis 1.17

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 17: Blood loss: postoperative (mL, lower is better)

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Analysis 1.18

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 18: Blood loss: overall blood loss (mL, lower is better)

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Analysis 1.19

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 19: Blood loss: change in haemoglobin (g/dL, lower is better)

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Analysis 1.20

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 20: Economic: length of hospital stay (days, lower is better)

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Analysis 1.21

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 21: Economic: duration of surgery (minutes, lower is better)

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Analysis 1.22

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 22: Implant stability: maximum total point motion at 8 weeks (mm, lower is better)

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Analysis 1.23

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 23: Implant stability: maximum total point motion at 1 year (mm, lower is better)

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Analysis 1.24

Comparison 1: Surgery with a tourniquet vs surgery without a tourniquet, Outcome 24: Implant stability: maximum total point motion at 2 years (mm, lower is better)

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Summary of findings 1. Knee replacement with tourniquet compared to knee replacement without tourniquet

Participants: patients undergoing knee replacement surgery Settings: hospitals around the world performing knee replacement surgery Intervention: surgery performed with a tourniquet for all or part of the procedure Comparator: surgery performed without a tourniquet
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk without tourniquet	Risk with tourniquet	Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Pain Visual analogue scale (VAS) for pain from zero to 10 (higher scores indicate more pain) Follow‐up day 1 postoperative pain scores	Mean pain was 4.56	MD 1.25 worse pain (0.32 worse to 2.19 worse)	‐	577 (8 RCTs)	⊕⊕⊕⊝ MODERATE^a	Knee replacement with a tourniquet led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients ^b Absolute difference 12.5% worse (3.2% worse to 21.9% worse) Relative difference 19% worse (3.4% worse to 49% worse)^c
Function Similar 0 to 100 scales (100 is best) were used to measure the same conceptual functional outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS‐ADL); Knee Society Score (KSS); Hospital for Special Surgery Score (HSS) Follow‐up 12 months	Mean function was 90.03	MD 0.29 worse function (1.06 worse to 0.48 better)^d	‐	611 (5 RCTs)	⊕⊕⊕⊝ MODERATE^a	Knee replacement with tourniquet probably has little or no meaningful effect on function ^b Absolute difference 0.29% worse (1.06% worse to 0.48% better) Relative difference 0.57% worse (2.07% worse to 0.94% better)^c
Global assessment of success Participants reporting overall successful treatment and satisfaction^e Follow‐up 6 months	940 per 1000	940 per 1000 (855 to 1034)	RR 1.0 (0.91 to 1.10)	100 (1 RCT)	⊕⊕⊝ LOW^a,f	Number of participants reporting success may not differ Absolute difference 0% (8.5% worse to 9.4% better) Relative difference 0% (9% worse to 10% better)
Health‐related quality of life SF‐12 mental component from zero to 100 (100 is best) Follow‐up 6 months	Mean health‐related quality of life was 54.64	MD 1.53 better (0.85 worse to 3.91 better)		199 (1 RCT)	⊕⊕⊝ LOW^a,f	Knee replacement with tourniquet may have little or no meaningful effect on health‐related quality of life^b Absolute difference 1.53% better (0.85% worse to 3.91% better) Relative difference 3% better (2% worse to 7% better)^c
Serious adverse events	29 per 1000	59 per 1000 (32 to 79)	RR 1.73 (1.10 to 2.73)	1799 (21 RCTs)	⊕⊕⊕⊝ MODERATE^a	Knee replacement with tourniquet probably has a meaningful effect on risk of serious adverse events Absolute difference 2.1% more (0.29% more to 5.00% more)^g Relative difference 73% (10% more to 173% more) Number needed to harm (NNTH) is 48 (20 to 345) participants to have surgery with a tourniquet for 1 serious adverse event (venous thromboembolism, infection, or re‐operation)
Cognitive function	‐	‐	‐	‐	‐	No studies with adequate data
Survival of the implant Risk of revision At 1 year	9 per 1000	13 per 1000 (2 to 83)	RR 1.44 (0.23 to 8.92)	214 (3 RCTs)	⊕⊕⊕⊝ VERY LOW^a,f,h	It is uncertain if knee replacement has an effect on survival of implant at 1 year Absolute difference 0.4% more (0.7% less to 7% more) in the surgery with a tourniquet group Relative difference 44% more (77% lower to 892% more) in the surgery with a tourniquet group
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aDowngraded by one level due to risk of bias. Many studies had unclear risk of allocation concealment and unclear risk of participant blinding. ^bWe assumed that clinically important improvement was 1 point or 10% absolute improvement for pain on a VAS (0 to 10) (Dworkin 2008; Kelly 2001; Wall 2017); 5.3 points or 5.3% absolute improvement in KSS for function (Chean Lee 2017), and 10 points or 10% absolute improvement for health‐related quality of life. ^cRelative changes calculated relative to baseline in the surgery with a tourniquet group (i.e. absolute change (mean difference) divided by mean at baseline in the surgery without a tourniquet group from Liu 2017 b (values were 6.54 points on a 0 to 10 point VAS scale for pain and 51.3 on a 0 to 100 point KSS scale for function) and Goel 2019 (values were 54.64 on a 0 to 100 point SF‐12 mental component score for continuous outcomes). ^dThe mean difference was calculated by multiplying the SMD by the baseline SD (4.8) of the control group (Liu 2017 b). ^eParticipant satisfaction was derived from one study (Huang 2017). Satisfaction was defined as the number of participants who were 'extremely' or 'very' satisfied with their treatment. ^fDowngraded by one level due to imprecision. Small total number of participants. Not enough information to calculate effect estimate precisely. ^gConfidence intervals around absolute risk demonstrated an effect equal to or greater than 0.29%, which was deemed to be highly clinically relevant given the seriousness of the outcome. The total number of events was low; however, this was expected, and we did not downgrade for imprecision, as this was is in line with previous literature on SAEs (Benjamin 2016), which reported an incidence of VTE of 2.4% in patients undergoing TKR. Our results therefore do not indicate a 'low' total number of events for this outcome of interest. ^hDowngraded again due to very serious imprecision (only three events reported across the studies).

Summary of findings 1. Knee replacement with tourniquet compared to knee replacement without tourniquet

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Table 1. Baseline characteristics

Author	Number of participants	Number in tourniquet group	Number in control group	Mean age in tourniquet group (SD)	Mean age in control group (SD)	Proportion of males in tourniquet group, %	Proportion of males in control group, %	BMI in tourniquet group (SD)	BMI in control group (SD)
Abdel‐Salem 1995	80	40	40	73	73
Aglietti 2000	20	10	10	70 (8)	68 (4.5)	30	40	27.9	27.3
Alexandersson 2018	81	38	43	68 (7.4)	69.7 (6.4)	47	51	28.6 (3.4)	27.9 (3.5)
Ayik 2020	65	32	33	65.39 (7.25)	64.90 (6.58)	44	42	31.38 (4.72)	30.3 (7.1)
Clarke 2001	31	21	10
Dong 2019	122	58	64	68.2 (17.1)	69.5 (15.9)	34	35
Ejaz 2014	64	33	31	68 (8.4)	68 (7.4)	55	55	25 (2)	25 (2.5)
Ejaz 2015	62	31	31	68 (6.3)	68.2 (7.2)	52	55	25.1 (2)	25.2 (2.5)
Ejaz 2015 b	57	29	28	68.3 (8.4)	68.2 (7.8)	45	54	25.1 (2)	25.2 (2.5)
Goel 2019	199	100	99	66.0 (7.0)	65.5 (7.8)	50	48	30.9 (4.6)	31.3 (4.5)
Harston 2015	64	32	32	68 (8)	66 (8)			27.4	28.4
Huang 2017	100	50	50	66.2 (8.3)	65.1 (8.1)	36	32	25.1 (1.5)	24.2 (1.5)
Jawhar 2015	34	17	17	70.6 (6)	70.6 (6)	53	53	32.1 (5)	33.8 (5)
Jawhar 2019	99	50	49	69.3 (7.4)	68.3 ± 7.8	34	39	31.9 (6)	31.4 (5.5)
Juelsgaard 2001	30	16	14	69	64	44	29
Kato 2002	46	22	24	65	63
Kiss 2015	100	51	49	72.6 (7.1)	74.7 (7.4)	20	27	28.8 (3.9)	28.5 (3.3)
Kumar 2015	30	30	30	58	58	30	30
Ledin 2012	50	25	25	70 (8)	71 (6)	67	39	29 (4.8)	28 (4.8)
Li 2008	60	30	30	71 (7)	70 (7)			24 (5)	24 (5)
Li 2009	80	40	40	71 (6)	70 (7)	28	33	27.3 (6.3)	26.8 (5.1)
Liu 2014	20	10	10	67	60	70	90	25.5	28.7
Liu 2017	52	52	52	67 (8)	67 (8)			28.1 (5.5)	28.1 (5.5)
Liu 2017 b	26	26	26	65.8 (9.2)	65.8 (9.2)	35	35	28.2 (5.6)	28.2 (5.6)
Matziolis 2015	20	10	10	72.4	76.6	80	70	28.3	29.5
Molt 2014	60	30	30	70 (7)	67 (9)	53	53	28 (3)	28 (3)
Mori 2016	103	51	52	72.8 (7.3)	74.6 (7.6)	12	17	27.7 (3.4)	29.2 (3.9)
Ozkunt 018	49	24	25	65.05	65.05
Pfitzner 2014	90	45	45	69.3	70.5	47	24	27.8	26
Tai 2012	72	36	36	72.1 (6.9)	71.5 (6.8)			28.6 (4.5)	27.9 (4.2)
Tetro 2001	63	33	30	69.8 (6.7)	69.8 (9)	45	37
Vandenbussche 2001	80	40	40	72.5	68.5	22.5	40
Vertullo 2017	40	20	20	67.85 (6.91)	65.65 (8.54)	50	55	30.43 (5.07)	31 (5.31)
Wakankar 1999	77	37	40	72.5	71.8	30	35
Wauke 2002	37	19	18	63.2 (8.7)	61.4 (7.4)
Wu 2018	100	50	50	68.06 (3.16)	67.58 (4.61)	38	44	23.87 (2.13)	24.10 (2.16)
Yavarikia 2010	51	22	29	68	66	27	24
Zhang 2010	60	30	30	72 (6)	71 (6)	27	37	25 (4)	26 (4)
Zhang 2016	166	84	82	84	82
Zhou 2011	39	20	19	63.12 (6.79)	61.89 (7.93)	35	26
Zhou 2017	140	72	68	72	68	18	10	26.1 (4.1)	25.7 (3.4)

Table 1. Baseline characteristics

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Table 2. Statistical tests for publication bias

Outcome	Bias estimate (standard error)	P value
Pain	3.875 (2.168)	0.097
Intraoperative blood loss	‐8.732 (2.596)	0.005
Overall blood loss	5.585 (3.968)	0.178
Postoperative blood loss	‐0.049 (3.420)	0.989
Transfusion rate	0.47 (0.63)	0.468
Length of stay	0.219 (2.182)	0.922
Duration of surgery	‐2.947 (1.113)	0.014
Serious adverse events	0.567 (0.552)	0.318

Table 2. Statistical tests for publication bias

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Comparison 1. Surgery with a tourniquet vs surgery without a tourniquet

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Pain at different postoperative days (visual analogue scale 0 to 10, lower is better) Show forest plot	14		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1.1 Pain: day 1	8	577	Mean Difference (IV, Random, 95% CI)	1.25 [0.32, 2.19]
1.1.2 Pain: day 2	6	394	Mean Difference (IV, Random, 95% CI)	0.37 [‐0.03, 0.76]
1.1.3 Pain: day 3	10	807	Mean Difference (IV, Random, 95% CI)	0.78 [0.34, 1.23]
1.1.4 Pain: week 2	6	562	Mean Difference (IV, Random, 95% CI)	0.32 [0.12, 0.53]
1.1.5 Pain: week 6	6	637	Mean Difference (IV, Random, 95% CI)	0.38 [‐0.48, 1.23]
1.2 Function: patient‐reported knee function at 3 months (scale 0 to 100, higher is better) Show forest plot	4	425	Std. Mean Difference (IV, Random, 95% CI)	‐0.64 [‐1.52, 0.25]

1.3 Function: patient‐reported knee function at 12 months (scale 0 to 100, higher is better) Show forest plot	5	611	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.22, 0.10]

1.4 Global assessment of success: participant‐reported satisfaction at 3 months (based on number of participants, higher is better) Show forest plot	1	100	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.92, 1.14]

1.5 Global assessment of success: participant‐reported satisfaction at 6 months (based on number of participants, higher is better) Show forest plot	1	100	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.91, 1.10]

1.6 Health‐related quality of life: SF‐12 mental component at 6 weeks (0 to 100, higher is better) Show forest plot	1	199	Mean Difference (IV, Random, 95% CI)	2.58 [‐0.09, 5.25]

1.7 Health‐related quality of life: SF‐12 mental component at 6 months (0 to 100, higher is better) Show forest plot	1	199	Mean Difference (IV, Random, 95% CI)	1.53 [‐0.85, 3.91]

1.8 Serious adverse events Show forest plot	21	1799	Risk Ratio (M‐H, Random, 95% CI)	1.73 [1.10, 2.73]

1.9 Serious adverse event: venous thromboembolic event (VTE) Show forest plot	17	1575	Risk Ratio (M‐H, Random, 95% CI)	1.95 [0.99, 3.82]

1.10 Serious adverse event: deep vein thrombosis (DVT) Show forest plot	17	1602	Risk Ratio (M‐H, Random, 95% CI)	2.05 [1.35, 3.13]

1.10.1 Symptomatic DVT	16	1499	Risk Ratio (M‐H, Random, 95% CI)	1.83 [0.92, 3.65]
1.10.2 Asymptomatic DVT	1	103	Risk Ratio (M‐H, Random, 95% CI)	2.20 [1.29, 3.74]
1.11 Serious adverse event: pulmonary embolism (PE) Show forest plot	5	416	Risk Ratio (M‐H, Random, 95% CI)	4.51 [0.49, 41.81]

1.12 Serious adverse event: infection Show forest plot	9	846	Risk Ratio (M‐H, Random, 95% CI)	2.72 [1.15, 6.42]

1.13 Serious adverse event: re‐operation Show forest plot	3	157	Risk Ratio (M‐H, Random, 95% CI)	1.63 [0.61, 4.34]

1.14 Survival of the implant: risk of revision up to 2 years Show forest plot	3	214	Risk Ratio (M‐H, Random, 95% CI)	1.44 [0.23, 8.92]

1.15 Blood loss: postoperative transfusion risk (lower is better) Show forest plot	18	1286	Risk Ratio (M‐H, Random, 95% CI)	1.20 [0.86, 1.67]

1.16 Blood loss: intraoperative (mL, lower is better) Show forest plot	15	1187	Mean Difference (IV, Random, 95% CI)	‐147.05 [‐190.97, ‐103.12]

1.17 Blood loss: postoperative (mL, lower is better) Show forest plot	12	776	Mean Difference (IV, Random, 95% CI)	57.72 [13.58, 101.87]

1.18 Blood loss: overall blood loss (mL, lower is better) Show forest plot	18	1500	Mean Difference (IV, Random, 95% CI)	8.61 [‐83.76, 100.97]

1.19 Blood loss: change in haemoglobin (g/dL, lower is better) Show forest plot	9	713	Mean Difference (IV, Random, 95% CI)	‐0.14 [‐0.48, 0.19]

1.20 Economic: length of hospital stay (days, lower is better) Show forest plot	12	995	Mean Difference (IV, Random, 95% CI)	0.34 [0.03, 0.64]

1.21 Economic: duration of surgery (minutes, lower is better) Show forest plot	27	2070	Mean Difference (IV, Random, 95% CI)	‐3.70 [‐5.53, ‐1.87]

1.22 Implant stability: maximum total point motion at 8 weeks (mm, lower is better) Show forest plot	2	130	Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.13, 0.01]

1.23 Implant stability: maximum total point motion at 1 year (mm, lower is better) Show forest plot	2	130	Mean Difference (IV, Random, 95% CI)	0.05 [‐0.09, 0.18]

1.24 Implant stability: maximum total point motion at 2 years (mm, lower is better) Show forest plot	2	130	Mean Difference (IV, Random, 95% CI)	0.06 [‐0.08, 0.19]

Comparison 1. Surgery with a tourniquet vs surgery without a tourniquet

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