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

NCT06944964 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-15

No results posted yet for this 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.

Conditions

  • Distal Femur Fractures

Interventions

PROCEDURE

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.

PROCEDURE

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) .

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2030-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944964 on ClinicalTrials.gov