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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636375
• Other study ID #: MRI DAA/PA
• Status: Completed
• Start date: May 2012
• Est. completion date: July 2021

Study information

• Verified date: November 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Osteoarthritis, Hip

Locations

Country	Name	City	State
United States	NorthShoreLIJ/LenoxHill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in muscle volume at 6 weeks	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
Primary	Change from baseline in muscle volume at 6 months		6 months after surgery
Secondary	Change in Fatty atrophy of muscles from baseline at 6weeks	Qualitative assessment of fatty atrophy	6 weeks after surgery
Secondary	tendon damage	Qualitative assessment of tendon damage on MRI	6 weeks after surgery
Secondary	Change in fatty atrophy of muscles from baseline at 6 months		6 months after surgery
Secondary	Tendon damage		6 months after surgery