Rommens 1993.
Study characteristics | ||
Methods | Method of randomisation: alternation Assessor blinding: unlikely Loss to follow‐up at 3 weeks: 0/28 | |
Participants | Leuven University Hospital, Belgium Period of study recruitment: 1991 28 participants with acute 2‐ and 3‐part proximal humeral fractures (but most were non‐ or minimally displaced). Exclusion criteria: those indicated for surgical intervention, age < 15 years, with multiple injuries or other fractures at same site 22 female, 6 male; mean age 69 years, range 25 to 100 years | |
Interventions | Interventions started immediately. 1. Gilchrist bandage, 2 to 3 weeks. The arm was bandaged with mesh type tubing and held by two slings: one round the shoulder and neck and the other which immobilised the distal part of the upper arm. (Bandage allowed wrist and hand exercises.) 2. Desault bandage, 2 to 3 weeks. Arm was immobilised to the chest using a circular elastic body bandage. (Some had one or more strips of plaster to stop the bandage slipping.) Assigned: 14/14 Completed (at fracture consolidation): 14/14 | |
Outcomes | Length of follow‐up: until fracture consolidation; also assessed at 1 and 3 weeks Functional results: overall result, no data Pain: patient questionnaire, 0 (none) to 100 (significant) scale Displacement of fracture Complication: skin irritation Removal of bandage Surgeon assessment of ease of application of bandage Patient assessment of bandage | |
Funding and conflict of interest statements | There was no statement on funding. There was no statement on conflicts of interest. | |
Notes | Two fractures in the Gilchrist group required reduction. Seven participants had other fractures: 3 in group 1 (2 rib, 1 vertebra); 4 in group 2 (1 ankle, 1 hip, 1 rib, 1 vertebra). Trial reports in German; translation obtained. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quasi‐randomised: alternation |
Allocation concealment (selection bias) | High risk | Alternation |
Blinding (performance bias and detection bias) Functional outcomes, pain, clinical outcomes, complications | High risk | No mention of blinding |
Incomplete outcome data (attrition bias) Functional outcomes, pain, clinical outcomes, complications | Unclear risk | While all participants were followed up and intention‐to‐treat analyses seemed to have been done, no data on function were presented nor were the criteria for judging fracture consolidation. |
Selective reporting (reporting bias) | High risk | Insufficient information to judge this, but data not provided on function |
Balance in baseline characteristics? | Unclear risk | Small discrepancies (e.g. in other injuries or having fracture reduction) can have bigger consequences for small group sizes. |
Free from performance bias? | Unclear risk | Differences in care programmes cannot be ruled out. |