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

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see which type of surgical treatment works better for older adults or those with certain health issues who have broken their thigh bone (distal femur fractures). The two treatments being compared are single implant fixation (SIF) and dual implant fixation (DIF). The main goals are to find out if using two implants (DIF) helps patients recover better than using one (SIF) and to understand how easy it is to recruit and keep participants in the study.

To participate, individuals should be at least 60 years old or between 18-60 with specific health concerns like osteoporosis or obesity. Participants will be randomly assigned to receive either SIF or DIF and will need to visit the clinic for follow-ups to check on their recovery and bone healing. It’s important to note that the trial is not yet recruiting participants, but if you or a family member are eligible and interested, it could provide valuable information about the best ways to treat this type of fracture.

Gender

ALL

Eligibility criteria

• 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