NCT01766648.
Study name | Multicentre, randomized trial of far cortical locking versus standard constructs for acute, displaced fractures of the distal femur treated with locked plate fixation |
Methods | Interventional, randomised, efficacy study. Participants will be assigned to a single group |
Participants | Estimated enrolment: 130 participants Inclusion criteria: men or women aged ≥ 18 years; displaced distal femur fracture (OTA 33A or 33C) as seen in x‐rays; planned treatment using a distal femur locking plate; fractures < 14 days' postinjury; provision of informed consent Exclusion criteria: open distal femur fracture; vascular injury present at the site of the fracture; planned fixation strategy includes interfragmentary lag fixation of non‐articular fractures; history of previous femur infection; limited life expectancy due to significant medical comorbidity or medical contraindication to surgery; inability to comply with rehabilitation or form completion; likely problems, in the judgement of the investigators, with maintaining follow‐up (i.e. people with no fixed address, people not mentally competent to give consent, etc.) |
Interventions | Participants were allocated to either:
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Outcomes | Primary outcome
Secondary outcomes:
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Starting date | December 2013 |
Contact information | Benita Okocha; Division of Orthopaedic Trauma, Vancouver General Hospital, Canada; benita.okocha@vch.ca |
Notes |