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Recruiting NCT05805774

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

No phase Interventional Distal Femur Fracture Periprosthetic Fracture Around Prosthetic Joint Implant Knee Knee Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Distal Femur Replacement, Surgical fixation.
Who it may be relevant to
Registry conditions: Distal Femur Fracture, Periprosthetic Fracture Around Prosthetic Joint Implant Knee, Knee Fracture. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femur Replacement (DFR)

Overview

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.

Interventions

  • Procedure 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).
  • Procedure 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 measures

  • Knee function [Time frame: 12 months]
Secondary outcome measures (1)
  • Mortality [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St. Michael's Hospital — Toronto

Identifiers

NCT: NCT05805774 · 23-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗