Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-06 @ 9:55 AM
Study NCT ID:
NCT03184051
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2017-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the correlation between the Time of Flight (TOF) of ultrasounds between the two interfaces (bone / cartilage and cartilage / water) and the real thickness of the cartilage measured by Magnetic Resonance Imaging (MRI).', 'timeFrame': '5 months', 'description': 'Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.', 'timeFrame': '5 months', 'description': 'Correlation coefficients between the US propagation velocity measurements and OA progression according to the seven groups of the OARSI scale.\n\nPosition indicators of US propagation velocity measurements of the 2 groups "early stage" (0 \\<= OARSI \\<= 2) and "advanced stage" (3 \\<= OARSI \\<= 6).'}, {'measure': 'Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data', 'timeFrame': '5 months', 'description': 'Correlation coefficient between surface area of samples and defects estimated from ultrasound data and those derived from MRI data.\n\nCorrelation coefficients between surface volumes of samples and defects estimated from ultrasound data and those derived from MRI data.'}, {'measure': 'Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.', 'timeFrame': '5 months', 'description': 'Correlation coefficients between thickness measurements estimated from MRI data and those estimated from histological data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee', 'Osteoarthritis', 'Ultrasonography evaluation/ultrasound', 'Articular cartilage', 'UltraSound Speed Of Sound (US-SOS)', 'UltraSound Time of Flight (US-TOF)'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cic-it.fr/cic-it-grenoble.php', 'label': 'Description: Clinical Investigation Centre for Innovative Technology Network website'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.', 'detailedDescription': 'Knee osteoarthritis (OA) is a common degenerative disease of synovial joint becoming more frequent with age. Among techniques have been used to diagnose and classify the severity of knee OA, the imaging techniques, such as ultrasonography (US), provide physical quantitative informations for better understanding and assessing of the pathology of the knee joint.\n\nThe present study aim to investigate the diagnostic performance of ultrasonography for femoral condyle cartilage evaluation using MRI and histology analysis as reference tools. To validate this approach, evaluations are conducted to determine, whether the UltraSound Speed Of Sound (US-SOS) propagation is associated with the variation of the arthrosis stage, in order to improve the diagnosis of the surgeon. For this purpose, measurements are conducted using selected human cartilage samples with different stage of OA (early stage and advanced stage).\n\nThis research is the first "preclinical" study of a new unlabelled medical device developed by Cartimage Medical SAS. Cartilage is a prospective, monocentric, unrandomized and uncontrolled study. This study doesn\'t modify the medical care of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with knee osteoarthritis with an indication of total arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient over 18 year old\n* knee osteoarthritis which total knee arthroplasty indication\n* who have signed a non-objection form.\n\nExclusion Criteria:\n\n* person who refuse to sign a non-objection form\n* person deprived of liberty by judicial or administrative decision\n* person under legal protection or unable to express their consent\n* person hospitalized for psychiatric care'}, 'identificationModule': {'nctId': 'NCT03184051', 'acronym': 'CARTILAGE', 'briefTitle': 'Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis', 'orgStudyIdInfo': {'id': '38RC17.074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound assessment', 'description': 'All subject of the study have a knee osteoarthritis (OA) and are going to have a total arthroplasty. Diagnostic performance of ultrasonography is evaluated on ex vivo cartilage samples (2 samples per patient are selected with different stage of OA : 1 with early stage and 1 with advanced stage).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Orthopedic Surgery Department, University Hospital, Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Alexandre Moreau -Gaudry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIMC-IMAG', 'class': 'OTHER'}, {'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}