Kopylov 1999.

Methods	Randomised by envelopes (stratification by gender and fracture type (extra‐ or intra‐articular)) drawn by nurse before surgery Assessor blinding: not reported (some independent assessors and independent checks of data collection) Intention‐to‐treat analysis: likely Loss to follow up: 2 (at 1 year)
Participants	Teaching Hospital, Sweden 40 participants Inclusion criteria: redisplaced unstable distal radial fracture (redisplaced to 20 degrees dorsal angulation or 2+ mm axial compression or 2+ mm incongruity in radiocarpal or distal radio‐ulnar joints) within 7‐10 days after initial reduction; women age 50‐80 years; men 60‐80 years. Written consent. Exclusion criteria: not stated. Classification: not stated (extra‐articular and intra‐articular) Sex: 36 female Age: mean 67 years Assigned: 20/20 [bone substitute / Ext‐fix ] Assessed: 19/19 (1 year)
Interventions	Timing of intervention: after 7‐10 days from initial reduction and injury. All had closed reduction using fingertraps. (1) Fracture exposed through < 5 cm dorsal incision. After clean‐up (haematoma, callus and debris were scrapped out), Norian skeletal repair system (SRS) ‐ bone cement ‐ injected to fill defect. Short arm dorsal splint for 2 weeks, then wrist mobilisation (2) Limited open incision then Hoffman external fixator for 5 weeks. Two pins inserted into 2nd metacarpal and 2 into radial shaft. Fixator removed and wrist mobilised after 5 weeks. All had physiotherapy as indicated.
Outcomes	Length of follow up: 1 year; also assessed at 1 day, 2, 5 and 7 weeks, and 3 and 6 months post‐op. (1) Functional: residual disability (VAS), grip strength, pain (VAS), range of movement (extension and supination). (2) Clinical: patient satisfaction (VAS ‐ no data). Complications: CTS, pin track infection, skin adhesion, wrist swelling, tendon rupture (EPL), persistent finger stiffness, extrusion of Norian SRS (no data). (3) Anatomical: X‐ray at all follow‐up times. Radial angle, dorsal angle, ulnar variance, lateral angle between scaphoid and lunate.
Notes	All patients operated on by one surgeon. No results were available from two reports for this trial. One reported radiostereometric analysis results of a sub‐group of 23 trial participants. The other, a conference abstract, reported on an "incidental finding" of resorption of the lateral aspect of the ulnar styloid process in 27 participants. Extra details, including method of randomisation received from Philippe Kopylov
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear