Comparison of Muscle Atrophy After Direct Anterior & Posterior Total Hip Arthroplasty
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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 |
- Change in muscle volume from baseline 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 in muscle volume from baseline at 6 months [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
Patients undergoing Total Hip arthroplasty by one of the two fellowship trained arthroplasty surgeons.
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.
Contacts and Locations| Contact: Parthiv Rathod, MD | prathod@nshs.edu |
| United States, New York | |
| NorthShoreLIJ/LenoxHill Hospital | Recruiting |
| New York, New York, United States, 10075 | |
| 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: | July 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Muscular Atrophy Osteoarthritis Osteoarthritis, Hip Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Pathological Conditions, Anatomical Signs and Symptoms Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013