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. 2008 Apr 23;2008(2):CD006836. doi: 10.1002/14651858.CD006836.pub2

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.
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.
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