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. 2022 Feb 10;2022(2):CD013405. doi: 10.1002/14651858.CD013405.pub2

Schipper 2004.

Study characteristics
Methods RCT; parallel design
Review comparison group: Gamma nail versus PFN
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)
  • Age, mean: 82.2 years

  • Gender, M/F: 37/176

  • Cognitive status, MMSE < 24, n: 76

  • ASA status, I/II/III: 68/50/93

  • Fracture classification, A2/A3, n: 165/48

  • HHS, mean: 70.3


Intervention group 2 (PFN)
  • Age, mean (SD): 82.6 years

  • Gender, M/F: 38/176

  • Cognitive status, MMSE < 24, n: 76

  • ASA status, I/II/III: 66/53/88

  • Fracture classification, A2/A3, n: 156/55

  • HHS, mean: 68.9


Note:
  • study authors report no baseline characteristics for: smoking history; medication; BMI; comorbidities; mobility assessment; place of residence; cognitive status/dementia; preoperative waiting time

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:
  • Gamma nail (Stryker); length 200 mm; femoral head fixation with a single screw

  • Number randomised to group = 213


Intervention group 2:
  • Proximal femoral nail (Mathys); length 240 mm; femoral head fixation with two screws

  • Number randomised to group = 211


Note:
  • study authors do not report pre‐/postoperative care

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)
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:
  • we did not conduct risk of bias assessment for this study because we were unable to include any data in the networks.