Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT04076735

DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Led by Unity Health Toronto · Updated on 2026-05-06

140

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

Sponsors

U

Unity Health Toronto

Lead Sponsor

M

Mount Sinai Hospital, Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in the correct position, until the fracture as healed. However, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal). Another treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization. There is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.

CONDITIONS

Official Title

DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients
  • 65 years and older
  • Isolated fracture of the distal femur (Classification 33)
  • Fracture is suitable for either surgical fixation or distal femoral replacement
  • Fracture occurred within 2 weeks before enrollment
  • Patient was ambulatory, with or without walking aids, before the injury
  • Independent or moderately frail with a Clinical Frailty Scale score between 3 and 6
  • Able to read and understand English, French, or Spanish
  • Patient or substitute decision maker can give written informed consent
Not Eligible

You will not qualify if you...

  • Active or previous infection around the fracture site (soft tissue or bone)
  • Open fracture
  • Fractures in both femurs
  • Major blood vessel injuries requiring treatment, compartment syndrome, or serious nerve injuries
  • Pathological fractures except those caused by osteoporosis
  • Previous surgical fixation or total knee replacement of the distal femur or proximal tibia
  • Previous surgical fixation or partial/total hip replacement
  • Past or current damage or repair of the knee extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture)
  • Multiple severe injuries (Injury Severity Score greater than 15) or major injuries to lower limbs
  • Diagnosed dementia
  • Medical or surgical contraindications to surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St Michael's Hospital - Unity Health Toronto

Toronto, Ontario, Canada

Actively Recruiting

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Research Team

C

Cassandra Tardif-Theriault, BKin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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