Methods |
Randomisation used random numbers generated from the 'Medstat' program
Assessor blinding: not stated
Intention‐to‐treat analysis: only for those followed up
Loss to follow‐up: 7 (15%) |
Participants |
University hospitals, Denmark
46 participants. Of 39 analysed: 19 male (49%), median age 44 years, range 12‐85 years. Transverse, oblique and comminuted fractures included.
Inclusion criteria: closed midshaft or distal isolated ulnar fracture.
Exclusion criteria: proximal ulnar fracture, Monteggia fracture dislocations |
Interventions |
Interventions started after initial immobilisation in an above elbow cast aimed to relieve pain and allow swelling to subside. Interventions removed when healed.
1. Short arm pre‐fabricated functional brace
2. Long arm plaster cast
Allocated: 23/23
Assessed: 20/19 |
Outcomes |
Length of follow‐up: maximum 20 weeks
Fracture union (radiographic and pain free)
Patient evaluation: satisfaction, pain
Range of motion (wrist, elbow, forearm: elbow extension/flexion, forearm pronation/supination and wrist extension/flexion)
Anatomic: varus and volar/dorsal angulation
Return to previous employment, use of device at work |
Notes |
Letter from Gebuhr gave details of the method of randomisation. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation "used random numbers generated from the 'Medstat' program". |
Allocation concealment (selection bias) |
Unclear risk |
No confirmation of this: "allocated randomly". |
Blinding (performance bias and detection bias)
Patient‐rated outcomes |
High risk |
There was no report of blinding. |
Blinding (performance bias and detection bias)
Clinician‐rated outcomes |
Unclear risk |
There was no report of blinding. |
Incomplete outcome data (attrition bias)
Patient‐rated outcomes |
Low risk |
Moderate loss to follow‐up: 7/46 (15%). Six participants failed to attend follow‐up examinations but this is unlikely to affect results. |
Incomplete outcome data (attrition bias)
Clinician‐rated outcomes |
Unclear risk |
Moderate loss to follow‐up: 7/46 (15%). Treatment group of person with putative non‐union who had operation not known. |
Selective reporting (reporting bias) |
Unclear risk |
Reports on typical set of outcomes for these fractures. |
Selection bias (baseline imbalances)? |
Unclear risk |
Brace group were younger (mean age 42 versus 48 years) but otherwise characteristics of the participants included in the analyses of the two groups seemed comparable. However, data for 7 participants are missing. |
Performance bias (care programme discrepancies)? |
Unclear risk |
Insufficient information ‐ initial treatment was the same and subsequent advice on activity seemed similar too. |