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Clinical Trials/NCT01636375
NCT01636375
Completed
Not Applicable

The Influence of Operative Approach on Muscle Atrophy After Total Hip Arthroplasty: A Comparison of Anterior and Posterior Approaches

Northwell Health1 site in 1 country19 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Hip
Sponsor
Northwell Health
Enrollment
19
Locations
1
Primary Endpoint
Change from baseline in muscle volume at 6 weeks
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
July 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Rodriguez, MD

MD, Director, Center For Joint Preservation & Reconstruction,NorthShoreLIJ/LenoxHill Hospital

Northwell Health

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

Change from baseline in muscle volume at 6 months

Time Frame: 6 months after surgery

Secondary Outcomes

  • tendon damage(6 weeks after surgery)
  • Change in Fatty atrophy of muscles from baseline at 6weeks(6 weeks after surgery)
  • Change in fatty atrophy of muscles from baseline at 6 months(6 months after surgery)
  • Tendon damage(6 months after surgery)

Study Sites (1)

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