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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jose Rodriguez, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01636375
First received: June 29, 2012
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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
Osteoarthritis, Hip

Study Type: Observational
Study Design: 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

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Change from baseline in muscle volume at 6 weeks [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    Muscle volume will be recorded in MRI images with specialized software (external rotators,tensor fascia lata, rectus femoris,gluteus medius and minimus)

  • Change from baseline in muscle volume at 6 months [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fatty atrophy of muscles from baseline at 6weeks [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    Qualitative assessment of fatty atrophy

  • tendon damage [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    Qualitative assessment of tendon damage on MRI

  • Change in fatty atrophy of muscles from baseline at 6 months [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Tendon damage [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Direct Anterior Approach
Posterior Approach

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing Total Hip arthroplasty by one of the two fellowship trained arthroplasty surgeons.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636375

Locations
United States, New York
NorthShoreLIJ/LenoxHill Hospital
New York, New York, United States, 10075
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Jose A Rodriguez, MD NorthShoreLIJ/LenoxHill Hospital
  More Information

No publications provided

Responsible Party: Jose Rodriguez, MD, MD, Director, Center For Joint Preservation & Reconstruction,NorthShoreLIJ/LenoxHill Hospital, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01636375     History of Changes
Other Study ID Numbers: MRI DAA/PA
Study First Received: June 29, 2012
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscular Atrophy
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Atrophy
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014