Status:
RECRUITING
Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Orthopaedic Trauma Association
Conditions:
Distal Femur Fractures
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 (D...
Detailed Description
The Investigators aim to conduct a multi-centre, preliminary RCT to determine the feasibility and inform the design of a definitive trial comparing patient-important outcomes between patients aged 40 ...
Eligibility Criteria
Inclusion
- Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
- Rorabeck type 1, 2) and either:
- Age ≥ 60 years or;
- Age 18-60 years with one or more of:
- i. Osteoporosis ii. Obesity (Body Mass Index \>30) iii. Metaphyseal comminution iv. Diabetes
- 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
- Candidate for primary or revision arthroplasty (surgeon opinion)
- Periprosthetic fracture with loose implant
- Gustillo grade III open fractures
- Ipsilateral hip implant
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
- Non-ambulatory patients
- Multi-trauma patient (Injury Severity Score ≥ 16)
- Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible
- Any concomitant lower-extremity injury
- Inability to obtain informed consent due to language barrier
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06944964
Start Date
September 1 2025
End Date
May 1 2030
Last Update
September 15 2025
Active Locations (2)
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1
Fraser Orthopaedic Institute
New Westminster, British Columbia, Canada
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5