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DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Study acronym: DIFFIR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 10, 2025 to Dec 31, 2027 Completion date: Oct 10, 2028 to Dec 31, 2028 · Collaborators: 20 to 21v9 Show 2 more changesShow less
    • Completion date: Oct 10, 2028 to Dec 31, 2028
    • Collaborators: 20 to 21

    See this version in full on ClinicalTrials.gov ↗

  2. Site contact updated Collaborators: 19 to 20v8 Show 1 more changeShow less
    • Collaborators: 19 to 20

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  3. Primary completion date: Dec 10, 2024 to Dec 10, 2025 Completion date: Oct 10, 2026 to Oct 10, 2028v7 Show 1 more changeShow less
    • Completion date: Oct 10, 2026 to Oct 10, 2028
  4. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Jun 10, 2022 to Dec 10, 2024 · Start date: Mar 16, 2020 to Oct 1, 2021 · Completion date: Oct 10, 2025 to Oct 10, 2026 · 2 morev6 Show 5 more changesShow less
    • Primary completion date: Jun 10, 2022 to Dec 10, 2024
    • Start date: Mar 16, 2020 to Oct 1, 2021
    • Completion date: Oct 10, 2025 to Oct 10, 2026
    • Site details revised
    • Collaborators: 15 to 19

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv5
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  1. Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 1 · Primary completion date: Feb 10, 2022 to Jun 10, 2022 · Completion date: Feb 10, 2023 to Oct 10, 2025 · 4 morev4 Show 7 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 10, 2022 to Jun 10, 2022
    • Completion date: Feb 10, 2023 to Oct 10, 2025
    • Start date changed from estimate of Feb 10, 2020 to Mar 16, 2020
    • Secondary endpoints: 5 to 6
    • Collaborators: 11 to 15
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 130 to 140 Eligibility criteria expanded, about 11 words · Collaborators: 7 to 11v3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Collaborators: 7 to 11

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jan 10, 2020 to Feb 10, 2020 Enrollment target: 112 to 130 · Primary completion date: Jan 10, 2022 to Feb 10, 2022 · Completion date: Jan 10, 2023 to Feb 10, 2023 · 2 morev2 Show 5 more changesShow less
    • Enrollment target: 112 to 130
    • Primary completion date: Jan 10, 2022 to Feb 10, 2022
    • Completion date: Jan 10, 2023 to Feb 10, 2023
    • Eligibility criteria shortened, about 43 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04076735
Lead Sponsor Unity Health Toronto
Collaborators: Mount Sinai Hospital, Canada, NYU Langone Health, Brigham and Women's Hospital, Queen Elizabeth II Health Sciences Centre, Hamilton Health Sciences Corporation, Yale New Haven Health System Center for Healthcare Solutions, Oregon Health and Science University, OrthoCincy Orthopaedics & Sports Medicine, University of California, Hospital for Special Surgery, New York, Stanford University, Cedars-Sinai Medical Center, Thunder Bay Regional Health Sciences Centre, University of California, San Francisco, University of Arkansas, University of Calgary, Ascension Health, University of Otago, Gold Coast University Hospital, Australia, Humber River Hospital, Ottawa Hospital Research Institute
Conditions Distal Femur Fracture
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov