Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults (NCT06944964) | Clinical Trial Compass
RecruitingNot Applicable
Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
Canada44 participantsStarted 2025-09-01
Plain-language summary
The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
* Can DIF improve patient outcomes compared to SIF in older or compromised adults?
* How feasible is it to recruit and retain participants for this trial?
Participants will:
1. Be randomly assigned to receive either SIF or DIF for their DFF treatment
2. Visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union.
Who can participate
Age range
18 Years – 100 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.
Inclusion criteria
. Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
. Age ≥ 60 years or;
. Age 18-60 years with one or more of:
. Fracture amenable to plating and nailing
. Ability to read and speak English or availability of a translator
. Acute fractures (within 14-days of injury)
. No surgeon preference regarding SIF vs. DIF
. Provision of informed consent
Exclusion criteria
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.
What they're measuring
1
Feasibility Outcomes - Recruitment
Timeframe: Through study completion, an average of 1 year.
2
Feasibility Outcomes - Retention
Timeframe: Through study completion, an average of 1 year.
3
Functional Ability
Timeframe: 2 year
Trial details
NCT IDNCT06944964
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's