Single versus dual implant fixation for fixing distal femur (lower thigh) fractures in older or medically vulnerable adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• London Health Sciences Centre
  London, Ontario, Canada Recruiting
• Fraser Orthopaedic Institute
  New Westminster, British Columbia, Canada Not yet recruiting

Study contacts

• Study coordinator: Emil Schemitsch, MD, FRCS(C)
• Email: Emil.Schemitsch@lhsc.on.ca
• Phone: 519-685-8500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Carbon‑fiber lateral plate versus plate-and-nail repair for distal femur fractures

  This trial will see if a carbon-fiber (CarboFix) lateral femur plate leads to fewer non-unions than the standard plate-plus-nail repair in adults having surgery for a distal femur fracture.

  Recruiting University of Missouri-Columbia · Columbia, Missouri · NCT07280169

• Comparing knee joint replacement to surgical fixation for elderly patients with distal femur fractures

  This study is testing whether total knee joint replacement or surgical fixation works better for older patients with broken thigh bones near their knee to help them feel less pain and improve their daily activities.

  Recruiting Unity Health Toronto · Toronto, Ontario · NCT05805774

• Comparing two surgical methods for treating distal femur fractures

  This study is testing which of two surgical methods works better for helping older patients recover from specific knee fractures after they've had knee replacement surgery.

  Recruiting University of Florida · Gainesville, Florida · NCT05792189

• Comparing knee replacement to surgical fixation for elderly patients with distal femur fractures

  This study is trying to see if knee replacement or surgical fixation works better for older patients with certain types of thigh bone fractures.

  Recruiting Unity Health Toronto · Toronto, Ontario · NCT04076735

• Robot-assisted closed reduction for femoral shaft fractures

  This study tests whether robot-assisted closed reduction leads to better fracture alignment and recovery than conventional reduction in adults with unilateral, acute femoral shaft fractures.

  Recruiting Beijing Jishuitan Hospital · Beijing, Beijing Municipality · NCT07738380

• Robot-assisted closed reduction and fixation for intertrochanteric hip fractures

  This study tests whether a robotic system can better align and fix certain hip fractures in adults 18–80 compared with standard manual methods.

  Recruiting Beijing Jishuitan Hospital · Beijing, Beijing Municipality · NCT07738458

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.