Schmalholz 1990.
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 1 year) | |
Participants | Teaching hospital, Sweden 50 participants Inclusion criteria: closed redisplaced unstable distal radial fracture, dorsal angulation 30+ degrees and / or axial compression 5+ mm following second closed manipulation. Frykman type I and II fractures. Exclusion criteria: intra‐articular fracture, severely comminuted fracture, associated distal ulnar fracture (except ulnar styloid), previous distal radial fracture, mentally disturbed patients. Classification: Frykman (I & II: extra‐articular) Sex: 46 female (of 48) Age: (of 48) median 66‐67 years, range 50 ‐ 81 years Assigned: 23/27 [bone substitute / Ext‐fix] Assessed: 23/25 (at 1 year) | |
Interventions | Timing of intervention: varied, 14 to 18 days post injury (median 16 days).
(1) Open reduction at 14‐18 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 regional anaesthesia, and 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). All had verbal and written instructions on exercises ‐ those (1:8) patients unable to follow programme themselves helped by physiotherapist. |
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Outcomes | Length of follow up: 1 year after fixator removal; also assessed at plaster or fixator removal and 1, 3 and 6 months. (1) Functional: activities of daily living: combined score (Lidstrom 1959), mass grip strength, pain (own scale ‐ pain free during specific activities), range of motion (dorsiflexion, volar flexion, pronation, supination). (2) Clinical: cosmetic results ‐ patient satisfaction with appearance. Complications: equipment failure (pin loosening), pin track infection (all superficial), painful scar, fixator painful or uncomfortable, problems with finger movements. (3) Anatomical: X‐ray post surgery, post plaster/ fixator removal reduction and 1 year. Dorsal angulation, axial compression, disposition of cortical bone. |
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Notes | Numbers of patients with finger problems supplied by Anders Schmalholtz | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |