| Trial name or title |
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. Aged ≥ 18 years. Both men and women
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' post injury 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 co‐morbidity 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 |
Far cortical locking screw fixation (experimental)
Standard locking screw fixation (active‐comparator) |
| Outcomes |
Primary outcomes:
Secondary outcomes:
patient‐reported quality of life and computed tomography quantification of fracture callus volume (time frame: 6 weeks, 3 months, 6 months and 12 months) patient‐reported quality of life using 36‐item Short Form at the 4 follow‐up intervals and computed tomography scan at 3 months only
|
| Starting date |
December 2013 |
| Contact information |
Raman Johal, raman.johal@vch.ca |
| Notes |
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