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OpenTrials
Completed

NCT Number: NCT01636375

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NorthShoreLIJ/LenoxHill Hospital

New York, 10075, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. Change from baseline in muscle volume at 6 months

    Time frame: 6 months after surgery

Secondary outcomes

  1. Change in Fatty atrophy of muscles from baseline at 6weeks

    Time frame: 6 weeks after surgery

    Qualitative assessment of fatty atrophy

  2. tendon damage

    Time frame: 6 weeks after surgery

    Qualitative assessment of tendon damage on MRI

  3. Change in fatty atrophy of muscles from baseline at 6 months

    Time frame: 6 months after surgery

  4. Tendon damage

    Time frame: 6 months after surgery

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2012
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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