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

NCT06944964 · tracked via the Priya Life Science Canada tracker

Sponsor

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

Phase

Not applicable

Started

2025-09-01

Last updated

2025-09-15

Condition(s) studied

Distal Femur Fractures

Investigational drug(s) / intervention(s)

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

Single Implant Fixation (SIF): This intervention involves using one implant for fracture fixation. The implant can be either a lateral locked plate or a retrograde intramedullary nail, based on the surgeon's preference.

Dual Implant Fixation (DIF): This intervention involves using two implants for fracture fixation. The combination can be either dual plate fixation (DPF) or combination nail plate fixation (NPF) .

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Feasibility Outcomes - Recruitment — Through study completion, an average of 1 year.
Recruitment - 1) Recruitment (number of patients enrolled per-month). Success will be considered as each site enrolling a minimum mean of 0.6 patients per-month. This is a conservative estimate based on our previous trials in similar populations, and we expect that each site will screen a minimum of twice this number. * Number of patients enrolled per month * Success if each site able to enroll mean of 0.6 patients per month
Feasibility Outcomes - Retention — Through study completion, an average of 1 year.
Retention - (proportion of patients that complete one-year follow-up). Success will be considered a minimum of 85% of patients with complete one-year data. * Proportion of patients that complete 1 year follow up * Success: 85%
Functional Ability — 2 year
Via the validated Oxford Knee Score. It ranges from 0 to 48, with higher scores indicating better outcomes (i.e., less pain and better function).

Trial sites (2)

Facility	City	Region	Status
Fraser Orthopaedic Institute	New Westminster	British Columbia	Not Yet Recruiting
London Health Sciences Centre	London	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06944964 on ClinicalTrials.gov ↗ ← All trials in Canada