Single versus dual implant fixation for fixing distal femur (lower thigh) fractures in older or medically vulnerable adults
Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
We will randomly assign older or medically vulnerable adults with distal femur fractures to receive either a single implant or a dual implant fixation to see if dual fixation helps them heal and recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 2 sites (New Westminster, British Columbia and 1 other locations) |
| Trial ID | NCT06944964 on ClinicalTrials.gov |
What this trial studies
This is a multi-centre randomized pilot comparing single implant fixation (like a lateral locked plate or retrograde nail) to dual implant fixation (dual plates or a nail-plus-plate) for distal femur fractures in older or compromised adults. The trial primarily tests feasibility by measuring recruitment, retention, and site feedback to inform a larger definitive trial. It also pilots collection of patient-important outcomes including the Oxford Knee Score, other quality-of-life measures, and clinical healing measures. An ultrasound sub-study will explore the feasibility of using ultrasound to monitor bone healing and detect complications such as non-union.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults with an isolated distal femur fracture who are either age ≥60 or younger adults with risk factors (for example osteoporosis, BMI >30, metaphyseal comminution, or diabetes), whose fracture is amenable to plating or nailing, present within 14 days, and can consent and follow up.
Not a fit: Patients unlikely to benefit include those needing primary or revision arthroplasty, with a loose periprosthetic implant, Gustilo grade III open fractures, ipsilateral hip implants, non-ambulatory or multi-trauma patients, or those unlikely to maintain follow-up.
Why it matters
Potential benefit: If successful, dual fixation could lead to more reliable bone healing and better knee function for some patients with challenging distal femur fractures.
How similar studies have performed: There are biomechanical studies and case series suggesting potential advantages of dual fixation for unstable distal femur fractures, but no definitive randomized trials yet.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Westminster, British Columbia and 1 other locations
- Fraser Orthopaedic Institute — New Westminster, British Columbia, Canada (Not_yet_recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Emil Schemitsch, MD, FRCS(C)
- Email: Emil.Schemitsch@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.