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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636375
Recruitment Status : Active, not recruiting
First Posted : July 10, 2012
Last Update Posted : January 24, 2018
Information provided by (Responsible Party):
Jose Rodriguez, MD, Northwell Health

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
Osteoarthritis, Hip

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 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Direct Anterior Approach
Posterior Approach

Primary Outcome Measures :
  1. Change from baseline in muscle volume at 6 weeks [ Time Frame: 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 [ Time Frame: 6 months after surgery ]

Secondary Outcome Measures :
  1. Change in Fatty atrophy of muscles from baseline at 6weeks [ Time Frame: 6 weeks after surgery ]
    Qualitative assessment of fatty atrophy

  2. tendon damage [ Time Frame: 6 weeks after surgery ]
    Qualitative assessment of tendon damage on MRI

  3. Change in fatty atrophy of muscles from baseline at 6 months [ Time Frame: 6 months after surgery ]
  4. Tendon damage [ Time Frame: 6 months after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01636375

United States, New York
NorthShoreLIJ/LenoxHill Hospital
New York, New York, United States, 10075
Sponsors and Collaborators
Northwell Health
Principal Investigator: Jose A Rodriguez, MD NorthShoreLIJ/LenoxHill Hospital

Responsible Party: Jose Rodriguez, MD, MD, Director, Center For Joint Preservation & Reconstruction,NorthShoreLIJ/LenoxHill Hospital, Northwell Health Identifier: NCT01636375     History of Changes
Other Study ID Numbers: MRI DAA/PA
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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