Schmalholz 1989.
Methods | Randomised by date of birth Assessor blinding: not reported Intention‐to‐treat analysis: likely, but interim data not presented for 2 patients who died Loss to follow up: 2 (at 2 years) | |
Participants | Teaching hospital, Sweden 49 participants Inclusion criteria: closed redisplaced unstable distal radial fracture, dorsal angulation 30+ degrees and / or axial compression 5+ mm following second closed manipulation (done 8 to 14 days after initial reduction). Exclusion criteria: intra‐articular fracture, comminuted fracture (e.g. with associated distal ulnar fracture), previous fracture, mentally disturbed. Classification: non stated (extra‐articular) Sex: all female (49) Age: mean 68 years, range 47 ‐ 81 years Assigned: 25/24 [bone substitute / POP] Assessed: 24/23 (2 years) | |
Interventions | Timing of intervention: varied, second reduction 8 to 14 days after initial closed reduction for trial entry. (1) Open reduction at 14‐24 days (mean 18 days) post fracture (mostly regional anaesthesia) with bone cement (methylmethacrylate) to fill dorsal bone deficiency and dorsal plaster for 2 weeks. (2) Closed manipulation, mostly general anaesthesia, at 15‐24 days (mean 19 days) and low circular plaster cast with arm in slight ulnar deviation and pronation for 4 weeks. | |
Outcomes | Length of follow up: 2 years; also assessed at 2 weeks, 1, 3, 6, 12 and 18 months. (1) Functional: activities of daily living: combined score (Lidstrom 1959), mass grip strength, pain (own scale ‐ time when pain free), range of motion (flexion, extension, pronation, supination). (2) Clinical: cosmetic results ‐ patient satisfaction with appearance. Complications: median nerve palsy. (3) Anatomical: X‐ray pre/post reduction, 1, 6 months and 2 years. Dorsal angulation, axial compression, disposition of cortical bone. |
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Notes | Timing of intervention and anaesthetic use very different between groups. Raw data presented in table. Duration of immobilisation in the control group supplied by Anders Schmalholtz | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |