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

RecruitingNAAges 18 Years - 100 YearsAllLondon Health Sciences Centre Research Institute …
NCT06944964 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and Rorabeck type 1, 2) and either: 1. Age ≥ 60 years or; 2. Age 18-60 years with one or more of: i. Osteoporosis ii. Obesity (Body Mass Index \>30) iii. Metaphyseal comminution iv. Diabetes 2. Fracture amenable to plating and nailing 3. Ability to read and speak English or availability of a translator 4. Acute fractures (within 14-days of injury) 5. No surgeon preference regarding SIF vs. DIF 6. Provision of informed consent Exclusion Criteria: 1. Candidate for primary or revision arthroplasty (surgeon opinion) 2. Periprosthetic fracture with loose implant 3. Gustillo grade III open fractures 4. Ipsilateral hip implant 5. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.) 6. Non-ambulatory patients 7. Multi-trauma patient (Injury Severity Score ≥ 16) 8. Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible 9. Any concomitant lower-extremity injury 10. Inability to obtain informed consent due to language barrier
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What it tests

  • Single Implant Fixation (SIF)
  • Dual Implant Fixation (DIF)
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Where

2 sites
Fraser Orthopaedic Institute
New Westminster, Canada
London Health Sciences Centre
London, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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