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Comparison of Muscle Atrophy After Direct Anterior & Posterior Total Hip Arthroplasty

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT01636375
Collaborator
(none)
19
Enrollment
1
Location
110
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. First, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior approach and the posterior approach. Second, the investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage that should reasonably be expected to occur with both of these approaches. Third, the investigators will document the degree of recovery of the periprosthetic soft tissues post-surgery in both patient groups.

The investigators first hypothesis is that the posterior approach will demonstrate significantly more damage to the abductors, piriformis, and short external rotators than the direct anterior approach, which will demonstrate minimal soft tissue damage. The investigators second hypothesis is that both surgical approaches will cause some degree of baseline muscle damage and atrophy, in a predictable pattern. The investigators third hypothesis is that each of the surgical approaches inherently cause some degree of soft tissue damage, and that the periprosthetic soft tissues that are incised during the surgical exposure will recover in a predictable pattern which is consistent but unique within each group

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    19 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Influence of Operative Approach on Muscle Atrophy After Total Hip Arthroplasty: A Comparison of Anterior and Posterior Approaches
    Study Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Direct Anterior Approach
    Posterior Approach

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in muscle volume at 6 weeks [6 weeks after surgery]

      Muscle volume will be recorded in MRI images with specialized software (external rotators,tensor fascia lata, rectus femoris,gluteus medius and minimus)

    2. Change from baseline in muscle volume at 6 months [6 months after surgery]

    Secondary Outcome Measures

    1. Change in Fatty atrophy of muscles from baseline at 6weeks [6 weeks after surgery]

      Qualitative assessment of fatty atrophy

    2. tendon damage [6 weeks after surgery]

      Qualitative assessment of tendon damage on MRI

    3. Change in fatty atrophy of muscles from baseline at 6 months [6 months after surgery]

    4. Tendon damage [6 months after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients undergoing elective, primary total hip arthroplasty

    2. Use of Cementless Total Hip components

    3. Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis

    Exclusion Criteria:

    1. Prior surgery on the affected hip

    2. No implanted medical devices or metallic debris in the patient which will preclude use of MRI

    3. patients must be able to participate in standard post-arthroplasty rehabilitation protocols.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NorthShoreLIJ/LenoxHill Hospital New York New York United States 10075

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Jose A Rodriguez, MD, NorthShoreLIJ/LenoxHill Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jose Rodriguez, MD, MD, Director, Center For Joint Preservation & Reconstruction,NorthShoreLIJ/LenoxHill Hospital, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT01636375
    Other Study ID Numbers:
    • MRI DAA/PA
    First Posted:
    Jul 10, 2012
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Osteoarthritis, Hip
    Muscular Atrophy
    Atrophy

    Study Results

    No Results Posted as of Nov 19, 2021