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OpenTrials
Completed

NCT Number: NCT06571604

Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.

This study looks at how fat buildup in hip muscles relates to hip osteoarthritis and less favorable recovery after hip replacement surgery. While it is known that weak gluteal muscles might cause problems, it is not yet proven if this specifically leads to hip dislocation after surgery. The goal of this study is to compare fat buildup in gluteal muscles between patients who had a hip dislocation soon after surgery and those who did not.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nîmes

Nîmes, Gard, 30900, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primary THA with preoperative CT-scan

Exclusion criteria

  • malposition of acetabular implants outside the Lewinneck safe zone,
  • neurological or cognitive disorders,
  • associated spinal pathologies (within the context of a hip-spine syndrome),
  • chronic alcoholism,
  • aseptic osteonecrosis,
  • revision surgeries,
  • late dislocations attributed to polyethylene wear,
  • replacement following post-traumatic coxarthrosis due to acetabulum injuries.
  • diameters of the prosthetic heads ≠ 32mm

Treatment and study plan

Dislocation

Diagnostic Test

One episode of total hip dislocation diagnozied on Xray within 2 years of surgery

No dislocation

Diagnostic Test

No experience of dislocation within two years post-surgery

Primary outcomes

  1. Mean Attenuation Ratio

    Time frame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

    The mean attenuation ratio (MAR), representing muscle fat degeneration, corresponds to the mean grayscale pixels in the selected area, expressed in Hounsfield Units (HU). Subsequently, the segmentation process was applied, selectively retaining pixels within the range of -30 HU to 150 HU. This range corresponds to muscle fibers and intramuscular fat, effectively excluding extra-fascial fat and bone pixels.

Secondary outcomes

  1. Cross-Sectional Area

    Time frame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

    The cross-sectional area (CSA), measured in square centimeters (cm²) defines the average muscle surface area.

  2. Intramuscular Fatty Fraction

    Time frame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

    Finally, the intramuscular fatty fraction (IFF) or percentage of intramuscular fat was calculated using the IB Delta Suite plug-in with thresholds of -30/0/150. Pixels below -30 HU and above 150 HU were designated as extra-muscular, while pixels ranging between 0 HU and 150 HU represented muscle fibers. Pixels falling between -30 HU and 0 HU denoted intramuscular fat, constituting the IFF.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

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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