Figueiredo 2008.
Methods |
Study design: single‐centre, 2‐group, parallel‐design RCT Duration of the study: August 2005‐January 2007 Protocol was published before recruitment of participants: not reported, but no protocol was published Details of trial registration: not registered Funding sources: none known |
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Participants |
Place of study: 1 centre from Taubaté, Brazil Number of participants assigned: 50 participants Number of participants assessed: 40 participants (24 surgical; 16 conservative) Inclusion criteria
Exclusion criteria
Age
Gender of participants assessed (male/female)
Classification of injury: not specified |
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Interventions |
Timing of intervention: not reported Type of surgical intervention: open reduction with 3.5‐mm DCP plate fixation (antero‐inferior position) Type of conservative intervention: Velpeau sling for 6 weeks Rehabilitation:
Any co‐interventions: not reported |
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Outcomes |
Length of follow‐up (mean/range): 16/12‐24 months. The length of follow‐up was not pre‐specified Loss to follow‐up: 10 participants were lost to follow‐up:
Primary outcomes
Secondary outcomes Other treatment failure measured by:
Adverse events measured by:
Return to previous activities:
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Notes |
Composite adverse events: surgery: (n = 0). Conservative: stiffness/restricted range of shoulder movement (n = 2). In Analysis 1.14 we used event rates 0 for surgery and 2 for conservative. Cosmetic result events: surgery: unsightly scar (n = 3). Conservative: deformity (n = 7). In Analysis 1.11 we used event rates 3 for surgery and 7 for conservative. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | Outcome assessors were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The study authors did not specify which groups the 10 participants that were lost to follow‐up belonged to |
Selective reporting (reporting bias) | High risk | Pain (as primary outcome) was reported incompletely so that it cannot be entered into a meta‐analysis |
Other bias | High risk | The time points of outcomes were not pre‐specified |