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 range18 Years – 100 Years
SexALL
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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
✕. Candidate for primary or revision arthroplasty (surgeon opinion)
✕. Periprosthetic fracture with loose implant
✕. Gustillo grade III open fractures
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
✕. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)