Actively Recruiting
Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-09-15
44
Participants Needed
2
Research Sites
243 weeks
Total Duration
On this page
Sponsors
L
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
O
Orthopaedic Trauma Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Isolated distal femur fracture (AO/OTA-type A2, A3, C or periprosthetic Lewis and Rorabeck type 1, 2) with either:
- Age 60 years or older, or
- Age 18 to 60 years with one or more of: osteoporosis, obesity (BMI >30), metaphyseal comminution, or diabetes
- Fracture suitable for plating and nailing
- Ability to read and speak English or have a translator available
- Acute fracture within 14 days of injury
- No surgeon preference between single or dual implant fixation
- Provided informed consent
You will not qualify if you...
- Candidate for primary or revision arthroplasty (per surgeon's opinion)
- Periprosthetic fracture with loose implant
- Gustillo grade III open fractures
- Ipsilateral hip implant present
- Likely difficulty maintaining follow-up (e.g., no fixed address)
- Non-ambulatory patients
- Multi-trauma patients with Injury Severity Score 16 or higher
- Poor bone quality making fixation impossible (per surgeon's judgment)
- Any other lower-extremity injury
- Unable to provide informed consent due to language barrier
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fraser Orthopaedic Institute
New Westminster, British Columbia, Canada
Not Yet Recruiting
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
Research Team
E
Emil Schemitsch, MD, FRCS(C)
CONTACT
A
Abdel-Rahman Lawendy, MD, FRCS(C)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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