Recruiting

Fixation vs. Replacement

Sponsor:

Unity Health Toronto

Code:

NCT05805774

Conditions

Distal Femur Fracture

Periprosthetic Fracture Around Prosthetic Joint Implant Knee

Knee Fracture

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Distal Femur Replacement

Surgical fixation

Study Details

Brief summary:

Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint).

The primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments.

A total of 148 patients (74/group) will be enrolled in the study.

Conditions

Distal Femur Fracture

Periprosthetic Fracture Around Prosthetic Joint Implant Knee

Knee Fracture

Study ID

NCT05805774

Start date

Oct 17, 2025

Status verified date

Dec, 2025

Completion date

Dec 10, 2032

Anticipated

Primary completion date

Dec 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • 65 years and older

  • Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
  • Fracture is acute (within 1 week from time of injury)
  • Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
  • Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale
  • Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up
  • Patient or substitute decision maker is able to provide written informed consent to participate in the study

Exclusion Criteria:

  • • Active infection around the fracture (soft tissue or bone)

  • Open fracture
  • Bilateral femur fractures
  • Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries
  • Pathological fracture excluding osteoporosis
  • Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components)
  • Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III)
  • Ipsilateral primary partial knee or patellofemoral arthroplasty
  • Previous ORIF of the distal femur or proximal tibia or patella
  • Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
  • Poly-trauma status (Injury Severity Score>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation
  • Medical contraindication to surgery

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A - DFR

active comparator: Group B - ORIF

Interventions

Distal Femur Replacement

Knee surgery to remove the lower part of the femur and knee joint (where the broken bones are) and will replace them with an artificial knee joint (prosthesis).

Surgical fixation

Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.

Primary outcome measure

  • Knee function [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Cassandra Tardif-Theriault

416-864-6060cassandra.tardif-theriault@unityhealth.to

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Cassandra Tardif-Theriault

416-864-6060cassandra.tardif-theriault@unityhealth.to

Principal Investigator:

Amir Khoshbin, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • Periprosthetic Distal Femur fracture
  • Knee replacement
  • Surgical fixation
  • Geriatric patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-12-18.