- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01636375
Comparison of Muscle Atrophy After Direct Anterior & Posterior Total Hip Arthroplasty
The Influence of Operative Approach on Muscle Atrophy After Total Hip Arthroplasty: A Comparison of Anterior and Posterior Approaches
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10075
- NorthShoreLIJ/LenoxHill Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing elective, primary total hip arthroplasty
- Use of Cementless Total Hip components
- Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis
Exclusion Criteria:
- Prior surgery on the affected hip
- No implanted medical devices or metallic debris in the patient which will preclude use of MRI
- patients must be able to participate in standard post-arthroplasty rehabilitation protocols.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Direct Anterior Approach
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Posterior Approach
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 weeks after surgery
|
|
Change from baseline in muscle volume at 6 months
Time Frame: 6 months after surgery
|
6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fatty atrophy of muscles from baseline at 6weeks
Time Frame: 6 weeks after surgery
|
Qualitative assessment of fatty atrophy
|
6 weeks after surgery
|
|
tendon damage
Time Frame: 6 weeks after surgery
|
Qualitative assessment of tendon damage on MRI
|
6 weeks after surgery
|
|
Change in fatty atrophy of muscles from baseline at 6 months
Time Frame: 6 months after surgery
|
6 months after surgery
|
|
|
Tendon damage
Time Frame: 6 months after surgery
|
6 months after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose A Rodriguez, MD, NorthShoreLIJ/LenoxHill Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRI DAA/PA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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