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To determine if Far Cortical Locking screws increase fracture healing rates at 3 months in Closed Distal Femur Fractures in adults when compared to Standard screw constructs.
Fracture healing at 3 months will be assessed via radiographic and clinical assessment of the fracture.
Null Hypothesis: There will be no difference in fracture healing at 3 months post-fixation between subjects treated with far cortical locking screw or standard screw fixation.
Full description
A multicentre randomized controlled trial with a sample size of 138 subjects.
Primary Outcome is fracture healing at 3 months via radiographic and and clinical assessment.
Radiographic healing will be defined as bridging of one or more cortices as seen on x-ray. Radiographic assessment will be centrally adjudicated by a committee of three study investigators.
Clinical healing will be assessed using the Function Index for Trauma (FIX-IT).
Secondary outcome measurements will include patient-reported quality of life and CT quantification of fracture callus volume.
Quality of life will be measured with the Short-Form 36 Version 2 (SF-36) instrument at all follow-up intervals.
A CT scan of the fracture site will be performed at the 3 month follow-up. Using a quantitative protocol the volume of callus will be measured and the extent of cortical bridging will be assessed.
Additional secondary outcomes include radiographic and clinical healing, as well as patient-important complications. These will include adverse events, delayed union (>6 months), non union (failure for fracture healing to progress on serial x-rays between 6 and 9 months), malalignment (>5 degrees), hardware failure, infection, and reoperation. Information surrounding the type of complication, duration, management and/or treatment of all complications will be recorded
A Data Safety Monitoring Board will be established to independently monitor trial data.
Specific inclusion criteria:
Specific exclusion criteria:
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167 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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