Ferran 2010.
Methods |
Study design: randomised controlled trial Duration of the study: 2006‐2008 Protocol was published before recruitment of participants: not reported Details of trial registration: not reported Funding sources: no conflict of interest |
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Participants |
Place of study: Wales, UK Number of participants assigned: 32 (17 intramedullary group; 15 plate group) Number of participants assessed: 32 (17 intramedullary group; 15 plate group) Inclusion criteria:
Exclusion criteria:
Age (mean/range):
Gender (male/female):
Side of injury (dominant/non‐dominant): not reported Classification of injury: not reported |
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Interventions |
Timing of intervention (mean/SD):
Intervention 1 (Intramedullary group):
Intervention 2 (Plate group):
Rehabilitation: For both groups, participants received arm sling protection for 2 weeks postoperatively and were encouraged to perform regular pendular exercises At 2 weeks, participants initiated gleno‐humeral range of motion exercises. For the first 6 weeks, abduction and forward flexion were limited to 90°. Beyond 6 weeks, full range of gleno‐humeral motion was encouraged Any co‐interventions: not reported |
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Outcomes |
Length of follow‐up:
Loss of follow‐up: 0 lost to follow‐up. Primary outcomes:
Secondary outcomes:
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Notes | After fracture healing, all pins were removed under local anaesthesia | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of generating the random sequence was not reported |
Allocation concealment (selection bias) | Low risk | Opaque and sealed envelopes were used |
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 | Low risk | There were no missing data |
Selective reporting (reporting bias) | High risk | The authors did not report outcomes at each time point, it was unclear when the outcomes were collected |
Other bias | High risk | Major baseline imbalance related to age of participants |