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pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement (pDIFFIR)

Primary Purpose

Distal Femur Fracture, Periprosthetic Fracture Around Prosthetic Joint Implant Knee, Knee Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Distal Femur Replacement
Surgical fixation
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fracture focused on measuring Periprosthetic Distal Femur fracture, Knee replacement, Surgical fixation, Geriatric patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A - DFR

    Group B - ORIF

    Arm Description

    Outcomes

    Primary Outcome Measures

    Knee function
    Compare knee pain between the two groups using the Oxford Knee Score - which is a patient reported outcome measure. It assess knee function and gives a rating from 0 to 48 - being 0 bad knee function and 48 - excellent knee function.

    Secondary Outcome Measures

    Mortality
    Track patient's death.

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05805774
    Brief Title
    pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
    Acronym
    pDIFFIR
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 10, 2023 (Anticipated)
    Primary Completion Date
    December 10, 2030 (Anticipated)
    Study Completion Date
    December 10, 2032 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Unity Health Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Femur Fracture, Periprosthetic Fracture Around Prosthetic Joint Implant Knee, Knee Fracture
    Keywords
    Periprosthetic Distal Femur fracture, Knee replacement, Surgical fixation, Geriatric patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    148 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A - DFR
    Arm Type
    Active Comparator
    Arm Title
    Group B - ORIF
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Distal Femur Replacement
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical fixation
    Intervention Description
    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 Information:
    Title
    Knee function
    Description
    Compare knee pain between the two groups using the Oxford Knee Score - which is a patient reported outcome measure. It assess knee function and gives a rating from 0 to 48 - being 0 bad knee function and 48 - excellent knee function.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    Track patient's death.
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luana Melo, PhD
    Phone
    416-864-6060
    Ext
    77286
    Email
    luana.melo@unityhealth.to
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amir Khoshbin, MD
    Organizational Affiliation
    Unity Health Toronto - St Michael's Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jesse Wolfstadt, MD
    Organizational Affiliation
    Mount Sinai Health Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

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