Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults

Recruiting now · Not applicable

Conditions studied: Distal Femur Fractures

In brief

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.

Key facts

Study ID

NCT06944964

Run by

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

People needed

44

Starts

2025-09-01

Expected to finish

2030-05-01

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• Fraser Orthopaedic Institute — New Westminster, British Columbia, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.