PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05677191
Collaborator
(none)
40
2
24

Study Details

Study Description

Brief Summary

Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures

Condition or Disease Intervention/Treatment Phase
  • Device: Proximal Femoral Nail
  • Combination Product: Dual Mobility Arthroplasty
Phase 2

Detailed Description

compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Usage Of Proximal Femoral Nail Versus Dual Mobility Arthroplasty In Treatment Of Unstable Trochanteric Fractures
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: proximal femoral nail

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

Device: Proximal Femoral Nail
open reduction
Other Names:
  • PFNA
  • Active Comparator: Dual Mobility Arthroplasty

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

    Combination Product: Dual Mobility Arthroplasty
    Hip Arthroplasty Surgery
    Other Names:
  • THA
  • Outcome Measures

    Primary Outcome Measures

    1. Hip score [Through study completion, an average of 1 year"]

      compare between hip score in first group of pfna versus hip score in second group of THA

    2. Operation time [During surgery]

      compartive operative time between first group of pfna versus second group of THA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marcos Hanna Morris, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05677191
    Other Study ID Numbers:
    • Orthopedic
    First Posted:
    Jan 10, 2023
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2023