DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Summary

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

• Distal Femur Fracture

Interventions

PROCEDURE

Distal femoral replacement

The distal portion of the femur (up to two thirds) is excised and replaced by a endoprosthesis incorporating a hinged total knee replacement.

PROCEDURE

Surgical Fixation (ORIF)

A trained orthopaedic surgeon uses open or minimally invasive reduction techniques and achieves stable fixation with internal fixation devices (plates/screws or intramedullary nail) to restore structural integrity and alignment of the distal femur

Sponsors & Collaborators

• Mount Sinai Hospital, Canada

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Queen Elizabeth II Health Sciences Centre

  collaborator OTHER

• Hamilton Health Sciences Corporation

  collaborator OTHER

• Yale New Haven Health System Center for Healthcare Solutions

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• OrthoCincy Orthopaedics & Sports Medicine

  collaborator UNKNOWN

• University of California

  collaborator OTHER

• Hospital for Special Surgery, New York

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Thunder Bay Regional Health Sciences Centre

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Ascension Health

  collaborator INDUSTRY

• University of Otago

  collaborator OTHER

• Gold Coast University Hospital, Australia

  collaborator UNKNOWN

• Humber River Hospital

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• Unity Health Toronto

  lead OTHER

Principal Investigators

• Amir Khoshbin, MD · St Michael's Hospital - Unity Health Toronto

• Jesse Wolfstadt, MD · Mount Sinai Hospital, University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• Canada

Study Locations