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

Completed

• Conditions: Muscle Degeneration; Total Hip Arthroplasty; Dislocation
• Interventions: Diagnostic Test: Dislocation; Diagnostic Test: No dislocation

• Registration Number: NCT06571604
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-03-01
• Study Completion: 2023-05-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dislocation group	Dislocation	Patients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation.
Control group	No dislocation	Patients underwent primary total hip arthroplasty with preoperative CT-scan, who did not experience any episodes of dislocation within two years post-surgery, adhering to the previously outlined exclusion criteria (group control).

Primary Outcome Measures

Name	Time	Method
Mean Attenuation Ratio	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 Outcome Measures

Name	Time	Method
Cross-Sectional Area	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.
Intramuscular Fatty Fraction	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.

Trial Locations

Locations (1)

CHU Nîmes; 🇫🇷 Nîmes, Gard, France