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PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures

Primary Purpose

Trochanteric Fractures

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Proximal Femoral Nail
Dual Mobility Arthroplasty
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trochanteric Fractures

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with trochanteric unstable fractures. age 60 or above recent fracture time within 2 weeks time period trochanteric starting point in pfna patients medical condition is stable Exclusion Criteria: stable trochanteric fractures delayed or neglected fractures unstable patients medical conditions pirformis fossa starting point in pfna

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    proximal femoral nail

    Dual Mobility Arthroplasty

    Arm Description

    20 patient with trochanteric fractures , unstable type will use proximal femoral nail

    20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty

    Outcomes

    Primary Outcome Measures

    Hip score
    compare between hip score in first group of pfna versus hip score in second group of THA
    Operation time
    compartive operative time between first group of pfna versus second group of THA

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2022
    Last Updated
    January 9, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05677191
    Brief Title
    PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures
    Official Title
    The Usage Of Proximal Femoral Nail Versus Dual Mobility Arthroplasty In Treatment Of Unstable Trochanteric Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures
    Detailed Description
    compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trochanteric Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    proximal femoral nail
    Arm Type
    Experimental
    Arm Description
    20 patient with trochanteric fractures , unstable type will use proximal femoral nail
    Arm Title
    Dual Mobility Arthroplasty
    Arm Type
    Active Comparator
    Arm Description
    20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty
    Intervention Type
    Device
    Intervention Name(s)
    Proximal Femoral Nail
    Other Intervention Name(s)
    PFNA
    Intervention Description
    open reduction
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dual Mobility Arthroplasty
    Other Intervention Name(s)
    THA
    Intervention Description
    Hip Arthroplasty Surgery
    Primary Outcome Measure Information:
    Title
    Hip score
    Description
    compare between hip score in first group of pfna versus hip score in second group of THA
    Time Frame
    Through study completion, an average of 1 year"
    Title
    Operation time
    Description
    compartive operative time between first group of pfna versus second group of THA
    Time Frame
    During surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with trochanteric unstable fractures. age 60 or above recent fracture time within 2 weeks time period trochanteric starting point in pfna patients medical condition is stable Exclusion Criteria: stable trochanteric fractures delayed or neglected fractures unstable patients medical conditions pirformis fossa starting point in pfna
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marcos Ha Morris
    Phone
    1287076751
    Ext
    0020
    Email
    marcos.hanna.morris@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures

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