Reindl 2015.
Study characteristics | ||
Methods | RCT; parallel design Review comparison group: intramedullary devices versus DHS |
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Participants |
Total number of randomised participants: 204 Inclusion criteria: unstable intertrochanteric hip fracture; ≥ 55 years of age; type 2 (AO/OTA 31 ‐ A2); isolated fracture; occurred < 2 weeks prior to the time of enrolment Exclusion criteria: fracture due to malignancy; inability to walk before the fracture; severe dementia; limited life expectancy due to substantial medical comorbidities; medical contraindication; inability to comply with rehab or complete the forms Setting: multicentre; 9 sites; Canada Baseline characteristics Intervention group 1 (intramedullary device)
Intervention group 2 (DHS)
Note:
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Interventions |
General details: fracture table; attempted closed reduction; use of fluoroscopic guidance; clinical evaluations at 6 weeks, 3, 6 and 12 months Intervention group 1
Intervention group 2
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Outcomes |
Outcomes measured/reported by study authors: available at 6 weeks, 3, 6 and 12 months: LEM; FIM; TUG; 2MWT; radiographic findings; implant position ‐ tip‐apex distance; femoral neck shortening; heterotopic ossification ‐ Brooker stage; complications; length of follow‐up: 12 months Outcomes relevant to the review: mortality and unplanned return to theatre (both 12 months) |
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Notes |
Funding/sponsor/declarations of interest: the study was directed by the Canadian Orthopaedic Trauma Society (COTS) with no other conflicts reported Study dates: February 2007 to November 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quotes: “Permuted block randomisation”,“randomly generated modality” |
Allocation concealment (selection bias) | Unclear risk | Quote: “sealed envelopes” Comment: study authors do not report whether envelopes are opaque and sequentially numbered |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | It is not possible to blind surgeons to the type of intervention. We did not, however, expect that this would influence surgeon performance. |
Other performance bias: surgeon experience of both implants | Unclear risk | Trial appears pragmatic in design. Multicentre trial with no information available on surgeon expertise |
Blinding of outcome assessment: mortality (detection bias) | Low risk | We did not expect that lack of blinding of outcome assessors would influence objective outcome data. |
Blinding of outcome assessment: unplanned return to theatre (detection bias) | High risk | It is not possible to blind surgeons to treatment groups. We judged that knowledge of the type of implant could influence judgments made by surgeons when assessing subjective outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses were balanced between groups and were mostly explained by death, which is expected in this population. |
Selective reporting (reporting bias) | Unclear risk | Registration with clinical trials register NCT00597779: first registered in January 2008 although study commenced in February 2007. It was not feasible to effectively assess risk of reporting bias using retrospectively‐prepared documents. We noted that SF‐36 was listed as an outcome, but was later dropped from the outcome list on the clinical trials register and was not reported in the published study report. |
Other bias | Low risk | We identified no other sources of bias. |