Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-02-28 @ 7:10 AM
Study NCT ID:
NCT02733900
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005271', 'term': 'Femur Head Necrosis'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Osseous modifications responsible of osteonecrosis', 'timeFrame': 'through the study completion, an average of 18 months'}], 'secondaryOutcomes': [{'measure': 'Total cross-sectional area', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar'}, {'measure': 'cortical bone area', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar'}, {'measure': 'cortical area fraction', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar'}, {'measure': 'cortical thickness', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar'}, {'measure': 'bone volume fraction', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral trabecular bone'}, {'measure': 'trabecular number', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral trabecular bone'}, {'measure': 'trabecular separation', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a nano-CT for the subchondral trabecular bone'}, {'measure': 'trabecular thickness', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'by using a contrast-enhanced nano-CT for the subchondral trabecular bone'}, {'measure': 'Physico-chemical composition of the trabecular subchondral bone', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'mineralisation, carbonation, crystallinity, secondary structure of collagen, maturity of collagen, relative content of proteoglycans. These measures will be done for the trabecular subchondral bone in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and in the cortical of the femoral collar'}, {'measure': 'Existence and extent of edema', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'this measure will be done on the T2-weighted sequences with fat suppression'}, {'measure': 'Perfusion MRI sequence', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'morphological aspect of the enhancement curve, semi-quantitative parameters (slope, area under the curve, time to peak) and pharmacokinetic parameters'}, {'measure': 'Medullary fat fraction in T1-weighted DIXON method', 'timeFrame': 'through the study completion, an average of 27 months', 'description': 'border of osteosclerosis, identification of a necrotic zone, extent of this zone'}, {'measure': 'Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining', 'timeFrame': 'through the study completion, an average of 27 months'}, {'measure': 'Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21', 'timeFrame': 'through the study completion, an average of 27 months'}, {'measure': 'Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining', 'timeFrame': 'through the study completion, an average of 27 months'}, {'measure': 'Mankin score for cartilage degradation by Safranin O staining', 'timeFrame': 'through the study completion, an average of 27 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aseptic osteonecrosis', 'femoral head', 'micro scanner', 'Raman spectrometry', 'MRI'], 'conditions': ['Femur Head Necrosis']}, 'descriptionModule': {'briefSummary': 'In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis of the femoral head and its structural evolution by the association of the micro scanner analysis and Raman spectrometry performed on the femoral heads removed during hip replacements. The study of femoral heads will allow the analysis of bone tissue at two different scales, both correlated with the biomechanical properties of the bone. Also, the association with preliminary MRI analysis will provide pathogenic explanations correlated to these modifications.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for experimental group:\n\n* Men\n* Patients aged from 25 to 70 years\n* Patient with an aseptic osteonecrosis of the femoral head established by medical Imaging (CT-scan, MRI or radiography)\n* FICAT stage 3 or 4\n* osteonecrosis etiologies : alcohol, corticosteroid therapy, idiopathic\n* Surgical indication of hip prosthesis determined\n\nInclusion Criteria for control group:\n\n* Men\n* Patients aged from 40 to 70 years\n* Patient with a primitive coxarthrosis\n* Surgical indication of hip prosthesis determined\n\nExclusion Criteria for the 2 groups:\n\n* Other causes of osteonecrosis (coagulopathy, barotrauma, trauma)\n* Prior fracture of the upper extremity of the femur\n* Prior cancer and hematological malignancies with bone locations\n* Prior debilitating bone diseases\n* Patient refusal to participate in the study\n* Patient who isn't affiliated to a social security regimen"}, 'identificationModule': {'nctId': 'NCT02733900', 'acronym': 'ONTF', 'briefTitle': 'Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations', 'orgStudyIdInfo': {'id': 'RC-P0044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteonecrosis group', 'description': 'Patients with an aseptic osteonecrosis of the femoral head', 'interventionNames': ['Procedure: femoral head removal']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Patients with coxarthrosis', 'interventionNames': ['Procedure: femoral head removal']}], 'interventions': [{'name': 'femoral head removal', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group', 'Osteonecrosis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hospital Salengro CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59462', 'city': 'Lomme', 'country': 'France', 'facility': 'Hospital Group of the Catholic Institute of Lille', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'overallOfficials': [{'name': 'Tristan Pascart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Group of the Catholic Institute of Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}