Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures (NCT01766648) | Clinical Trial Compass
UnknownNot Applicable
Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures
Canada167 participantsStarted 2013-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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