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. 2022 Jun 21;2022(6):CD000434. doi: 10.1002/14651858.CD000434.pub5

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.
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.