Skip to main content
. 2022 Feb 10;2022(2):CD013405. doi: 10.1002/14651858.CD013405.pub2

Reindl 2015.

Study characteristics
Methods RCT; parallel design
Review comparison group: intramedullary devices versus DHS
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)
  • Age, mean (SD): 82 (± 8.6) years

  • Gender, M/F: 57/55


Intervention group 2 (DHS)
  • Age, mean (SD): 80 (± 9.9) years

  • Gender, M/F: 31/61


Note:
  • study authors did not report: smoking history, medication, BMI, comorbidities, mobility assessment cognitive status/dementia, preoperative waiting time

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
  • A choice of 3 intramedullary devices: trochanteric fixation nail (TFN) (Synthes), Gamma nail (Stryker) or Trigen Intertan nail (Smith & Nephew); short nails; dynamic fixation proximally and all were distally locked

  • Randomised = 112; devices: 42 = TFN, 48 = Intertan, 22 = Gamma nail; at 3 months = 96; at 12 months = 87 (13 died, 6 unwilling to continue, 5 unknown loss, 1 implant failure)


Intervention group 2
  • DHS (Synthes); plate ranges in length from two to six holes at the surgeon’s discretion

  • Randomised = 92; at 3 months = 85; at 12 months = 80 (6 died, 2 unwilling to continue, 2 unknown loss, 2 implant failure)

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)
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
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.