Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
1 other identifier
observational
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedAugust 26, 2024
August 1, 2024
1.2 years
August 23, 2024
August 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Attenuation Ratio
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.
The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Secondary Outcomes (2)
Cross-Sectional Area
The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Intramuscular Fatty Fraction
The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Study Arms (2)
Dislocation group
Patients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation.
Control group
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).
Interventions
One episode of total hip dislocation diagnozied on Xray within 2 years of surgery
No experience of dislocation within two years post-surgery
Eligibility Criteria
Patients following THA at Nimes university hospital
You may qualify if:
- primary THA with preoperative CT-scan
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Nîmes
Nîmes, Gard, 30900, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 26, 2024
Study Start
January 1, 2020
Primary Completion
March 1, 2021
Study Completion
May 1, 2023
Last Updated
August 26, 2024
Record last verified: 2024-08