Tabatabaei 2011.
Methods |
Study design: quasi‐randomised controlled trial Duration of the study: April 2008 to December 2010 Protocol was published before recruitment of participants: not reported Details of trial registration: prospectively registered in 2007 at WHO International Clinical Trial Registry (IRCT201105165920N3) Funding sources: study was supported by the grant number 2228 from Jundishapur University of Medical Sciences |
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Participants |
Place of study: Iran Number of participants assigned: 68 (34 intramedullary group; 34 plate group) Number of participants assessed: 50 (25 intramedullary group; 25 plate group) Inclusion criteria:
Exclusion criteria:
Age (mean/SD/range):
Gender (male/female):
Side of injury (dominant/non‐dominant): not reported Classification of injury: AO classification but the authors did not report |
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Interventions |
Timing of intervention: not reported. Intervention 1 (Intramedullary group):
Intervention 2 (Plate group):
Rehabilitation: the postoperative protocol was Velpeau bandage for a few days and then sling and early pendulum exercise. In the 6th week, if there was radiological union, the participant was allowed to perform restricted exercise. The participants were instructed not to perform contact sports until 12th week post operation Any co‐interventions: not reported |
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Outcomes |
Length of follow‐up: mean follow‐up was 6 months for all participants with clinical assessment at 2, 4, and 6 weeks and 6 months after operation Loss of follow‐up: 18 participants lost to follow‐up at 6 months: Primary outcomes:
Secondary outcomes:
Other outcomes assessed:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Sequence generated by some rule based on date (alternation): "We operated the first patient with pin and the other with plate and continued the operations in the same manner" |
Allocation concealment (selection bias) | High risk | Allocation was not concealed |
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 | > 80% of participants completed the follow‐up (50/68 participants, 73.5%) |
Selective reporting (reporting bias) | High risk | Outcomes of interest in the review are not reported (function, pain, and quality of life) |
Other bias | Unclear risk | Insufficient information to permit judgement |
3D: three‐dimensional; AO: Arbeitsgemeinschaft fur Osteosynthesefragen; DASH: Disabilities of the Arm, Shoulder and Hand questionnaire; DCP: dynamic compression plate; LC‐DCP: low‐contact dynamic compression plate; SD: standard deviation; TEN: titanium elastic nail; VAS: visual analogue scale; WHO: World Health Organization.