Schipper 2004.
| Study characteristics | ||
| Methods | RCT; parallel design Review comparison group: Gamma nail versus PFN |
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| Participants |
Total number of randomised participants: 424 Inclusion criteria: radiological diagnosis of an unstable trochanteric femoral fracture, classified as 31A2.1 to 3 and 31A3.1 to 3; > 60 years of age; signed informed consent Exclusion criteria: inability to walk before the fracture; other fracture interfering with rehabilitation; (suspicion of) pathological fracture Setting: multicentre; 9 hospitals; the Netherlands Baseline characteristics Intervention group 1 (Gamma)
Intervention group 2 (PFN)
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| Interventions |
General details: follow‐up was at 4 weeks, 4 months and 12 months; the anaesthesia was either general or regional but did not differ between groups nor did the level of experience of the surgeons; surgeons had experience with at least 5 procedures with both implants; routine prophylaxis for thrombosis given preoperatively and during postoperative hospital stay; prophylactic antibiotics given; all participants encouraged to walk fully weight bearing, starting as soon as possible after operation with support of a physiotherapist Intervention group 1:
Intervention group 2:
Note:
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| Outcomes |
Outcomes measured/reported by study authors: amount of fracture healing; intraoperative complications; re‐operations (available at 4 weeks, 4 months and 12 months); mortality (available at 4 weeks, 4 months and 12 months); blood loss; complications; mobility; operating time; fluoroscopy time; reduction of fracture Outcomes relevant to the review: mortality (reported at 4 months and 12 months); unplanned return to theatre (reported at 12 months) |
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| Notes |
Funding/sponsor/declarations of interest: study authors report "this research was equally supported by Stryker Howmedica and Mathys Medical Nederland. The authors have received benefits for professional use from both commercial parties related directly to the subject of this article. In addition, benefits have been directed to a research fund, foundation, educational institution, or other non‐profit organisations with which one or more of the authors is associated". Study dates: September 1998 to January 2002 Note:
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