Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures (FCL)
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About
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:
Men or women ages 18 years or older Displaced distal femur fracture (OTA 33A or 33C) as seen in radiographs Planned treatment using a distal femur locking plate Ability to read and speak English or availability of translator willing to assist with completion of study forms Fractures < 14 days post injury Provision of informed consent
Specific exclusion criteria:
Open distal femur fracture requiring flap or vascular repair (grade 3b or 3c) Planned fixation strategy includes interfragmentary lag fixation of non-articular fractures Active local 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 judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.) Non-ambulatory patients Lack of bone substance or poor bone quality which, in the surgeon's judgment, makes locked plate fixation impossible Periprosthetic fractures Any concomitant lower-extremity injury that requires non-weight-bearing beyond 6 weeks post-operative Addition of bone graft, bone graft substitute or BMP Pregnant women
Enrollment
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Inclusion and exclusion criteria
Specific inclusion criteria:
- Men or women ages 18 years or older
- Displaced distal femur fracture (OTA 33A or 33C) as seen in radiographs
- Planned treatment using a distal femur locking plate
- Ability to read and speak English or availability of translator willing to assist with completion of study forms
- Fractures < 14 days post injury
- Provision of informed consent
Specific exclusion criteria:
- Open distal femur fracture requiring flap or vascular repair (grade 3b or 3c)
- Planned fixation strategy includes interfragmentary lag fixation of non-articular fractures
- Active local 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 judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
- Non-ambulatory patients
- Lack of bone substance or poor bone quality which, in the surgeon's judgment, makes locked plate fixation impossible
- Periprosthetic fractures
- Any concomitant lower-extremity injury that requires non-weight-bearing beyond 6 weeks post-operative
- Addition of bone graft, bone graft substitute or BMP
- Pregnant women
Trial design
Primary purpose
Allocation
Interventional model
Masking
167 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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