Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT06571604
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Attenuation Ratio', 'timeFrame': 'The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cross-Sectional Area', 'timeFrame': 'The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.', 'description': 'The cross-sectional area (CSA), measured in square centimeters (cm²) defines the average muscle surface area.'}, {'measure': 'Intramuscular Fatty Fraction', 'timeFrame': 'The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Hip Arthroplasty', 'Muscle Fatty Degeneration', 'CT', 'Gluteal Muscles'], 'conditions': ['Dislocation', 'Total Hip Arthroplasty', 'Muscle Degeneration']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients following THA at Nimes university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary THA with preoperative CT-scan\n\nExclusion Criteria:\n\n* malposition of acetabular implants outside the Lewinneck safe zone,\n* neurological or cognitive disorders,\n* associated spinal pathologies (within the context of a hip-spine syndrome),\n* chronic alcoholism,\n* aseptic osteonecrosis,\n* revision surgeries,\n* late dislocations attributed to polyethylene wear,\n* replacement following post-traumatic coxarthrosis due to acetabulum injuries.\n* diameters of the prosthetic heads ≠ 32mm'}, 'identificationModule': {'nctId': 'NCT06571604', 'briefTitle': 'Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.', 'orgStudyIdInfo': {'id': 'THAdislocation glutealatrophy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dislocation group', 'description': 'Patients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation.', 'interventionNames': ['Diagnostic Test: Dislocation']}, {'label': 'Control group', 'description': '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).', 'interventionNames': ['Diagnostic Test: No dislocation']}], 'interventions': [{'name': 'Dislocation', 'type': 'DIAGNOSTIC_TEST', 'description': 'One episode of total hip dislocation diagnozied on Xray within 2 years of surgery', 'armGroupLabels': ['Dislocation group']}, {'name': 'No dislocation', 'type': 'DIAGNOSTIC_TEST', 'description': 'No experience of dislocation within two years post-surgery', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30900', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}