Name (reference ID)

Brief outline

Comment

AO (Arbeitsgemeinschaft fur Osteosynthesefragen) (Muller 1991)

This system is organised in order of increasing fracture severity. It divides the fractures into three major groups: group A (extra‐articular), group B (simple/partial intra‐articular), and group C (complex/complete intra‐articular). These three groups are then subdivided, yielding 27 different fracture types.

There is no assessment of the extent of fracture displacement.

Frykman
(Frykman 1967)

This system distinguishes between extra‐articular fractures and intra‐articular fractures of the radiocarpal and radio‐ulnar joints, and the presence or absence of an associated distal ulnar (ulnar styloid) fracture. There are 8 types labelled I to VIII (1 to 8): the higher the number, the greater complexity of the fracture.

There is no assessment of the extent or direction of fracture displacement, or of comminution.

Melone
(Melone 1993)

This system identifies 5 fracture types, based on 4 major fracture components: the radial shaft, the radial styloid, and the dorsal‐medial and volar‐medial fragments.

This is for intra‐articular fractures only.

Older
(Older 1965)

This system divides fractures into 4 types, labelled I to VI (1 to 4) of increasing severity. The types are defined according to extent of displacement (angulation and radial shortening) and comminution.

There is no consideration of radio‐ulnar joint involvement.

'Universal Classification' (Cooney 1993)

This system divides fractures into 4 main types, labelled I to VI (1 to 4), distinguishing between extra‐articular and intra‐articular fractures and displaced and non‐displaced fractures. Displaced fracture types II and IV are further subdivided based on reducibility (whether the fracture can be reduced; that is whether the bone fragments can be put back in place) and stability (whether, once reduced, the fragments will remain so).

This does not distinguish between the radiocarpal and radio‐ulnar joints. Additionally, there is a 'trial by treatment'.

Parameter

Definition

Normal value

Dorsal angulation (dorsal or volar or palmar tilt)

Angle between a) the line which connects the most distal points of the dorsal and volar cortical rims of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist with the forearm in neutral rotation.

Palmar or volar tilt: approximately 11‐12 degrees.

Radial length

Distance between a) a line drawn at the tip of the radial styloid process, perpendicular to the longitudinal axis of the radius and b) a second perpendicular line at the level of the distal articular surface of the ulnar head. Frontal view with the forearm in neutral rotation.

Approximately 11‐12 mm.

Radial angle or radial inclination

Angle between a) the line drawn from the tip of the radial styloid process to the ulnar corner of the articular surface of the distal end of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Frontal view with the forearm in neutral rotation.

Approximately 22‐23 degrees.

Ulnar variance

Vertical distance between a) a line drawn parallel to the proximal surface of the lunate facet of the distal radius and b) a line parallel to the articular surface of the ulnar head. Frontal view with the forearm in neutral rotation

Usually negative variance (e.g. ‐1 mm) or neutral variance.

Items

Scores

Notes

(1) Was the assigned treatment adequately concealed prior to allocation?

Y = method did not allow disclosure of assignment.
? = small but possible chance of disclosure of assignment or unclear.
N = quasi‐randomised, or open list or tables.

Cochrane code (see Handbook): Clearly yes = A; Not sure = B; Clearly no = C.

(2) Were the outcomes of participants who withdrew described and included in the analysis (intention‐to‐treat)?

Y = withdrawals well described and accounted for in analysis.
? = withdrawals described and analysis not possible, or probably no withdrawals.
N = no mention, inadequate mention, or obvious differences and no adjustment.

(3) Were the outcome assessors blinded to treatment status?

Y = effective action taken to blind assessors.
? = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
N = not mentioned or not possible.

(4) Were important baseline characteristics reported and comparable?

Y = good comparability of groups, or confounding adjusted for in analysis.
? = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
N = large potential for confounding, or not discussed.

Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture.

(5) Were the trial participants blind to assignment status after allocation?

Y = effective action taken to blind participants.
? = small or moderate chance of unblinding of participants.
N = not possible, or not mentioned (unless double‐blind), or possible but not done.

(6) Were the treatment providers blind to assignment status?

Y = effective action taken to blind treatment providers.
? = small or moderate chance of unblinding of treatment providers.
N = not possible, or not mentioned (unless double‐blind), or possible but not done.

(7) Were care programmes, other than the trial options, identical?

Y = care programmes clearly identical.
? = clear but trivial differences, or some evidence of comparability.
N = not mentioned or clear and important differences in care programmes.

Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.

(8) Were the inclusion and exclusion criteria for entry clearly defined?

Y = clearly defined (including type of fracture).
? = inadequately defined.
N = not defined.

(9) Were the outcome measures used clearly defined?

Y = clearly defined.
? = inadequately defined.
N = not defined.

(10) Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate; and were these clinically useful and did they include active follow up?

Y = optimal.
? = adequate.
N = not defined, not adequate.

(11) Was the timing (e.g. duration of surveillance) clinically appropriate?

Y = optimal. (> 1 year)
? = adequate. (6 months ‐ 1 year)
N = not defined, not adequate. (< 6 months)

Rank

Category

Definition

1

Beneficial

Interventions for which effectiveness has been demonstrated by clear evidence from randomised controlled trials, and for which expectation of harms is small compared with the benefits.

2

Likely to be beneficial

Interventions for which effectiveness is less well established than for those listed under "beneficial".

3

Trade off between benefits and harms

Interventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities.

4

Unknown effectiveness

Interventions for which there is currently insufficient data or data of inadequate quality.

5

Unlikely to be beneficial

Interventions for which lack of effectiveness is less well established than for those listed under "likely to be ineffective or harmful"

6

Likely to be ineffective or harmful

Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence.

Study ID

Participants

Fracture type and classification

Timing/ common interventions/ duration

Intervention

Control

Cassidy 2003

323; 84% female; mean age 64 years.

Unstable and / or displaced unilateral distal radius fracture resulting from a low energy impact. Extra‐articular (AO type: A2.1, A2.2, A3.1, A3.2, A3.3) or intra‐articular (C1.1, C1.2, C1.3, C2.1, C2.2).

Before 5 days from injury. Closed reduction. Optional use of K‐wires for fracture stabilisation. Duration of immobilisation differed in the two groups.

Bone substitute.
Norian SRS (calcium‐phosphate bone cement) injected percutaneously or through small incision into cavity (after clean‐up). Below‐elbow plaster cast for 2 weeks. Wrist and forearm exercises started at 2 weeks. Removable splint for 4 weeks.

Closed reduction and cast (108 people) or external fixator (54 people) for 6 to 8 weeks. Wrist and forearm exercises started after this.

Jeyam 2002

21; all female; mean age 73 years.

Displaced distal radius fracture. Melone type 1 or 2a fractures: intra‐articular.

Recruitment criteria within 7 days of injury. Closed reduction. Short‐arm cast for 4 weeks.

Bone substitute.
Hydroxyapatite bone cement inserted through small dorsal incision after clean‐up. Short‐arm cast for 4 weeks.

Kapandji's intrafocal pinning (2 or 3 K‐wires inserted at fracture site). Short‐arm cast for 4 weeks. K‐wires removed at 6 weeks.

Kopylov 1999

40; 90% female; mean age 67 years.

Redisplaced unstable distal radial fracture (20 degrees dorsal angulation or 2+ mm axial compression or 2+ mm incongruity in radiocarpal or distal radio‐ulnar joints). Extra‐articular and intra‐articular.

After 7‐10 days from initial reduction. Closed reduction in both groups. Duration of immobilisation differed in the two groups.

Bone substitute.
Fracture exposed through < 5 cm dorsal incision. After clean‐up, Norian skeletal repair system (SRS) ‐ bone cement ‐ injected to fill defect. Short arm dorsal splint for 2 weeks, then wrist mobilisation.

Hoffman external fixator 5 weeks. Two pins inserted into 2nd metacarpal and 2 into radial shaft. Wrist mobilised after 5 weeks.

Kopylov 2002

20; all female; mean age 66 years.

Redisplaced distal radial fracture (20 degrees dorsal angulation or 2+ mm axial shortening or 2+ mm incongruity in radio‐carpal or distal radio‐ulnar joints). Extra‐articular and intra‐articular.

After 7‐10 days from initial reduction. Plaster cast immobilisation for 1 week, then removable splint up to 3 weeks.

Bone substitute.
Closed reduction and fracture exposed through < 5 cm dorsal incision. After open reduction, as required, clean‐up, Norian skeletal repair system (SRS) ‐ bone cement ‐ injected to fill defect. Short arm dorsal splint for 1 week, then wrist mobilisation and instruction.

No change of cast or re‐reduction. Short arm dorsal splint for 1 week, then wrist mobilisation and instruction.

McQueen 1996

120; 89% female; mean age 63 years.

Redisplaced (>10 degrees dorsal angulation or > 3 mm radial shortening). AO types A and C (extra‐articular and intra‐articular).

Within 2 weeks from injury. Open reduction for graft group and closed reduction for plaster cast and external fixation groups. Immobilisation for 6 weeks.

Bone graft. Open reduction and bone graft (from iliac crest) held by 1 Kirschner wire, then forearm cast for 6 weeks

(1) Closed reduction and plaster cast for 6 weeks.
or
(2) Open incisions for pin insertion. Bridging of radiocarpal joint. Pennig external fixator for 6 weeks. Ball joint released for limited wrist motion in 30 patients at 3 weeks.

Rajan 2006

93; 81% female; mean age 61 years.

Unstable fracture either primarily or redisplaced. Instability defined if at least 2 criteria met: dorsal angulation > 20 degrees, loss of radial length > 10 mm, intra‐articular extension of fracture, severe dorsal metaphyseal comminution, radioulnar separation. AO types A3, C2 and C3 (extra‐ and intra‐articular)

Primary or secondary fixation at mean 5.5 days from injury. Open reduction and dorsal plate fixation. Dorsal splint then full forearm cast for 4 weeks.

Bone graft
Allogenic bone‐graft substitute (Tutoplast cancellous chips). Dorsal splint, then circular forearm cast for 4 weeks.

Bone graft
Autogenic bone‐graft (from iliac crest ). Dorsal splint, then circular forearm cast for 4 weeks.

Sanchez‐Sotelo 2000

110; 88% female; mean age 66 years.

AO: A3 (extra‐articular) or C2 (intra‐articular) distal radius fractures.

Soon after injury. Closed reduction.
Duration of immobilisation differed in the two groups.

Bone substitute. Debris etc removed through 1 cm incision and Norian SRS (calcium‐phosphate bone cement) injected into cavity. Below‐elbow cast for 2 weeks.

Below‐elbow cast for 6 weeks.

Schmalholz 1989

49; all female; mean age 68 years.

Redisplaced closed unstable extra‐articular distal radial fracture (dorsal angulation 30+ degrees and / or axial compression 5 mm) following second closed manipulation.

Varied, 8 to 24 days after initial closed reduction for trial entry. Open reduction at 14‐24 days post fracture for bone cement group and closed reduction 15‐24 days from plaster cast group.
Duration of immobilisation differed in the two groups.

Bone substitute. Open reduction and methylmethacrylate cement used to fill dorsal bone deficiency. Dorsal plaster for 2 weeks.

Closed reduction and below‐elbow plaster cast: for 4 weeks.

Schmalhotz 1990

50; 96% female; median age 66‐67 years.

Redisplaced closed unstable distal radial fracture (dorsal angulation 30+ degrees and / or axial compression 5 mm) following second closed manipulation. Frykman type I and II fractures: extra‐articular.

Varied, 14 to 18 days post injury. Open reduction for graft group and closed reduction for external fixator group. Duration of immobilisation differed in the two groups.

Bone substitute. Open reduction and methylmethacrylate cement used to fill dorsal bone deficiency. Dorsal plaster for 2 weeks.

External fixation ‐ 2 pins in 2nd metacarpal and 2 in radial shaft) ‐ with one bar Hoffman fixator for 33 to 40 days (5‐6 weeks).

Widman 2002

48; 69% female; mean age 51.5 years.

Severely displaced and comminuted distal radial fracture, Older type 3 (radial styloid process shortened > 4 mm distal to ulna) or type 4 (marked comminution and radial styloid process shortened to level of ulna or less). Older types 3 & 4; AO types A2, A3, C1, C2, C3 (extra‐articular and intra‐articular).

After treatment at A&E department. Closed and open reduction under general anesthesia for bone graft group and closed reduction under regional anaesthesia for control group.
Duration of immobilisation differed in the two groups.

Bone graft.
External fixation (using a half‐frame Hoffman external fixator: 2 pins in 2nd metacarpal and 2 in radial shaft) and cancellous bone graft (from iliac crest) inserted through 3‐4 cm dorsal incision into fracture cavity. External fixator for 3 weeks, then plaster cast, allowing volar flexion but limited extension, for 3 weeks.

External fixation alone. Removed after 6 weeks.

Study ID

Items and grades

Items and grades

Items and grades

Notes

Study ID

Item 1: Allocation concealment Item 2: Intention‐to‐treat analysis Item 3: Outcome assessor blinding Item 4: Comparable baseline characteristics

Item 5: Participant blinding Item 6: Treatment provider blinding Item 7: Identical care programmes Item 8: Clearly defined inclusion criteria

Item 9: Well defined outcome measures Item 10: Optimal outcome assessment Item 11: Optimal timing of follow up (> 1 year) In brackets: date of last follow up; % lost to last follow up

Comments and explanations for specific items

Cassidy 2003

?, Y, N, ?

N, N, N, Y

Y, Y, ? (1 year; 9%)

Item 4: there were significantly (P = 0.04) more females in the control group.
Item 7: There was an absence of data on care programmes. Also an imbalance in the use of supplemental wires (40% versus 51%)

Jeyam 2002

?, ?, N, ?

N, N, ?, Y

?, ?, ? (6 months; 14%)

Items 2 and 4: data were missing for three excluded patients (2 died; 1 had wrong operation).

Kopylov 1999

?, Y, N, Y

N, N, ?, Y

Y, ?, ? (1 year; 5%)

Item 3: there was, however, some independent checking of data collection and independent evaluation by a radiologist and a physiotherapist

Kopylov 2002

?, Y, N, Y

N, N, Y, Y

Y, ?, ? (6 months; 0%)

Item 3: there was, however, some independent checking of data collection and potentially independent evaluation by a physiotherapist and radiologist.
% loss to follow up: the two patients who refused to attend follow up were contacted by phone.

McQueen 1996

?, Y, N, ?

N, N, ?, Y

Y, ?, ? (1 year; 9%)

Item 4: the bone graft patients were on average 5 years younger than the external fixator or the control group patients.

Rajan 2006

N, N, N, ?

N, N, Y, Y

Y, ?, ? (1 year; 0%)

Item 1: quasi‐randomised trial based on date of admission
Item 2: results were not given for 3 patients who did not accept iliac crest surgery for bone harvesting; not clear if there were any withdrawals

Sanchez‐Sotelo 2000

?, ?, N, Y

N, N, ?, Y

Y, ?, ? (1 year; 0%?)

Item 2: not clear if there were any losses to follow up

Schmalholz 1989

N, ?, N, Y

N, N, N, Y

Y, ?, Y (2 years; 4%?)

Item 1: quasi‐randomised trial based on date of birth
Item 7: different methods of anaesthesia

Schmalholz 1989

N, ?, N, ?

N, N, ?, Y

Y, ?, Y (1 year after fixator removal; 4%?)

Item 1: quasi‐randomised trial based on date of birth
Item 7: different numbers had physiotherapy in the 2 groups

Widman 2002

?, ?, N, Y

N, N, N, Y

Y, ?, ? (1 year; 6%)

Item 7: including differences in anaesthesia and no information on post‐immobilisation care

Comparison

Category

Justification

Qualifiers

Comments

Bone scaffolding ‐ bone graft ‐ versus conservative treatment (plaster cast)

3: Trade off between benefits and harms:

Although the functional outcome was under‐reported in one small trial of redisplaced fractures, there was evidence of better anatomical outcomes in the autogenous bone graft group. There was no report of donor site morbidity or complications but even if none occurred in this trial these can be serious and long term.

(1) Minimal details were provided for the conservative treatment intervention; there remains a possibility of sub‐optimal application of plaster casts.

A grading of 4: unknown effectiveness could also apply to this comparison.

Bone scaffolding ‐ Norian SRS ‐ versus conservative treatment (plaster cast)

4: Unknown effectiveness

Not enough evidence from two heterogeneous trials, one which included only acute fractures and one which included only redisplaced fractures.

(1) The acute fracture trial had promising results but questions remain over complications. The extraosseous deposition of Norian SRS, which mainly caused patient discomfort, apparently reduced with improved surgical technique. There was, however, an unusually high (38/55) rate of remanipulation in the conservative treatment group.
(2) The redisplaced fracture trial was terminated early after just 20 people were recruited. The trial authors concluded that re‐reduction and bone substitution of redisplaced fractures was unnecessary where people were prepared to accept cosmetic deformity and the option of later corrective surgery.

There was earlier mobilisation in the operative group of trial of acute fractures. Early notice of these trial results favouring Norian SRS acted a spur for Cassidy 2003 (FDA trial).

Though providing an important perspective, particularly in the context of patient expectations and preferences, the evidence base for the trial of redisplaced fractures is still too small.

Bone scaffolding ‐ methylmethacrylate cement ‐ versus conservative treatment (plaster cast)

4: Unknown effectiveness

Not enough evidence from one small quasi‐randomised trial of redisplaced extra‐articular fractures.

(1) The trial results for the bone cement group were significantly more favourable for functional, pain and anatomical outcomes.
(2) Methylmethacrylate cement is a biologically inert material and generally viewed as undesirable in this situation although healing of the cortical bone around the bone cement was confirmed for all cases.

The follow up of two years for this small trial were probably not long enough to establish the long term consequences of using methylmethacrylate cement.

Bone substitute versus "conventional treatment" (plaster cast or external fixation).

4: Unknown effectiveness

Not enough evidence given the complex comparison and lack of statistically significant differences. It is likely that the claims of earlier recovery of function and pain with the bone substitute are true but the data for functional measures at the various follow‐up times were incomplete

(1) Met FDA (USA) safety requirements.
(2) Norian SRS was considered to be indicated for "low impact, unstable, metaphyseal distal radius fractures where early mobilisation is indicated" (FDA 1998)
(3) Many of the extraosseous deposits persisted and appeared associated with more complications. Questions remain about the long‐term complications such as arthritis, potentially from intra‐articular deposits, and refracture rate.
(4) There was optional use of supplementary wiring in both groups

Complex control group and comparison hampered interpretation. Norian SRS group mobilised at 2 weeks.

This was an industrially sponsored trial and the clear involvement of the company making Norian SRS, including commentary by an employee in the journal publication, should be noted.

Bone graft, external fixation then plaster cast versus external fixation

4: Unknown effectiveness

Not enough evidence from one small trial

(1) The invasive nature of bone graft harvesting and of bone graft insertion should not be overlooked.
(2) It is likely that the less serious donor‐site complications were not reported.

Though presented as a trial of primary bone grafting, the trial should be viewed in terms of the actual interventions (including a difference in methods and mobilisation after 3 weeks) under comparison.

Bone substitute versus percutaneous pinning

4: Unknown effectiveness

Not enough evidence from one small and potentially flawed trial despite some evidence of poorer results for a particular bone substitute (Bonesource: hydroxapatite cement), used without additional fixation, when compared with Kapandji intrafocal pinning by experienced operators for some types (Melone 1 and 2a) of intra‐articular fractures.

(1) Melone 1 fractures are defined as "stable after closed reduction" and thus some would consider that cast immobilisation would suffice (Melome 1993).
(2) Reservations with selection of the Kapandji pinning method are given in the percutaneous pinning review (Handoll 2007)

Despite the insufficient evidence, it is still plausible that Bonesource is not mechanically robust enough to be used without supplementary fixation.

Bone scaffolding ‐ bone graft or substitute ‐ versus external fixation

4: Unknown effectiveness

Not enough evidence from three small heterogeneous trials; each testing a different material: bone graft, methylmethacrylate cement and Norian SRS. All were redisplaced fractures.

(1) The majority of reported complications were in the external fixation group, but there remains the potential of under‐reported or long‐term complications of methylmethacrylate cement and Norian SRS.
(2) The trial using bone graft did not comment on donor site complications.

There was earlier mobilisation in the bone substitute groups of the two trials.

Allograft versus autograft

3: Trade off between benefits and harms

Although this is a small quasi‐randomised study there was some indication of better functional results for the autograft ‐ this needs confirmation ‐ but anyway these need to be set in the context of the serious and frequent complications recorded for the iliac crest bone extraction.

(1) The potential risks of disease transmission from allograft may remain hidden even after one year follow up.

Both groups had dorsal plate fixation.