Andersen 1987a.
Methods |
Study design: RCT Duration of the study: June 1981 to September 1982 Protocol was published before recruitment of patients: not reported Details of trial registration: not reported Intention‐to‐treat analysis: Likely, but outcome data for participants who had withdrawn from the trial or were lost to follow‐up were not presented Funding sources: not reported |
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Participants |
Location: Denmark Number of participants assigned: 79 (49 figure‐of‐eight bandage group; 34 arm sling group) Number of participants assessed: 61 (34 figure‐of‐eight bandage group; 27 arm sling group) Inclusion criteria:
Exclusion criteria:
Age (median; range):
Gender: not reported Side of injury: not reported Classification of injury: not reported, just fracture types (2 fragments, 1 intermediary fragment and 2 or more intermediary fragments) and fracture dislocations (undisplaced, minor displacement, major displacement) |
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Interventions |
Timing of intervention: after diagnosis Intervention 1 (figure‐of‐eight bandage):
Intervention 2 (arm sling):
Rehabilitation: not reported Any co‐interventions: not reported |
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Outcomes |
Length of follow‐up: The figure‐of‐eight group lasted a median interval of 12 weeks (10 to 16) and the sling group lasted a median interval of 13 weeks (10 to 17); the figure‐of‐eight group also was assessed at 2 days, 1 and 2 weeks Loss of follow‐up: 18 participants lost to follow‐up: Figure‐of‐eight bandage group ‐ 11 participants lost to follow‐up:
Arm sling group ‐ two seven participants lost to follow‐up:
Primary outcomes:
Secondary outcomes:
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Notes | The outcomes were evaluated by a non‐validated scoring system | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table was used |
Allocation concealment (selection bias) | Unclear risk | Details to ascertain that allocation was concealed were not provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes assessors were not blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Less than 80% of participants completed the follow‐up (23% of withdrawals) |
Selective reporting (reporting bias) | High risk | The authors used non‐validated scores to assess function and pain; treatment failure was not reported |
Other bias | Unclear risk | Insufficient information to permit judgement |