Judd 2009.
Methods |
Study design: single‐centre, 2‐group, parallel‐design RCT Duration of the study: February 2001‐June 2003 Protocol was published before recruitment of participants: not reported, but no protocol was published Details of trial registration: not registered Funding sources: study authors reported no potential conflict of interest and no funding sources |
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Participants |
Place of study: not reported, probably Hawaii Number of participants assigned: 57 participants (29 surgical; 28 conservative) Number of participants assessed: 57 participants (29 surgical; 28 conservative) Inclusion criteria
Exclusion criteria
Age
Gender of participants assigned (male/female)
Classification of injury: not specified, just fracture pattern (comminuted and displacement/shortening fractures) |
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Interventions |
Timing of intervention: participants were treated within 2 weeks Type of surgical intervention: open reduction and intramedullary fixation using a modified Hagie pin (Boehme 1991) Type of conservative intervention: sling for comfort, restrictions of shoulder motion as tolerated and restrictions of activities until healing of fracture occurred Rehabilitation: in both groups, gentle shoulder motion exercises and daily living activities were allowed as tolerated. After fracture healed, physical therapy with strength training and unrestricted activities were allowed. Any co‐interventions: not reported |
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Outcomes |
Length of follow‐up:
Loss to follow‐up: none lost to follow‐up Primary outcomes
Secondary outcomes: Other treatment failure measured by:
Adverse events measured by:
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Notes | After fracture healing, all pins were removed under local anaesthesia. Composite adverse events: surgery: local infection (n = 6); hardware prominence (n = 3); refracture (n = 2). Conservative: refracture (n = 1). In Analysis 1.14 we used event rates 6 for surgery and 1 for conservative. Cosmetic result events: surgery: prominent pins (n = 9). Conservative: deformity (n = 0). In Analysis 1.11 we used event rates 9 for surgery and 0 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) | Low risk | Sealed envelopes placed in a random order were used, and neither the treating surgeon nor the participant knew the intervention until the participant consented to participate in the study. |
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 | High risk | Missing outcome data were not balanced in numbers across intervention groups; more participants in the conservative intervention group were not assessed at all time points. |
Selective reporting (reporting bias) | High risk | Function or disability was measured by non‐standard validated participant‐reported measures. |
Other bias | Low risk | The study appears to be free of other potential sources of bias. |