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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.