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

NCT01636375 | Completed

• 1 other identifier: MRI DAA/PA
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

• 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

• Change from baseline in muscle volume at 6 months

  6 months after surgery

Secondary Outcomes (4)

• Change in Fatty atrophy of muscles from baseline at 6weeks

  6 weeks after surgery

• tendon damage

  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 Arms (2)

Direct Anterior Approach

Posterior Approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Total Hip arthroplasty by one of the two fellowship trained arthroplasty surgeons.

You may qualify if:

• Patients undergoing elective, primary total hip arthroplasty
• Use of Cementless Total Hip components
• Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

NorthShoreLIJ/LenoxHill Hospital

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jose A Rodriguez, MD

  NorthShoreLIJ/LenoxHill Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director, Center For Joint Preservation & Reconstruction,NorthShoreLIJ/LenoxHill Hospital

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 10, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

US (1)