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: far cortical locking screw fixation (experimental); standard locking screw fixation (active comparator).
Outcomes	Primary outcome Fracture healing at 3 months: radiographic and clinical assessment of fracture healing defined as bridging of ≥ 2 cortices. Clinical healing assessed with FIX‐IT Secondary outcomes: Participant‐reported quality of life and CT quantification of fracture callus volume (at 6 weeks, and 3, 6 and 12 months) Participant‐reported quality of life using 36‐item Short Form at 4 follow‐up intervals and CT scan at 3 months only
Starting date	December 2013
Contact information	Benita Okocha; Division of Orthopaedic Trauma, Vancouver General Hospital, Canada; benita.okocha@vch.ca
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