Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-27 @ 4:45 PM
Study NCT ID:
NCT05203757
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cone Beam CT (CBCT) Arthrogram of the Ankle in Assessement of Osteochondral or Cartilage Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Localisation of the lesions', 'timeFrame': 'at baseline', 'description': 'Localisation of cartilage and osteochondral lesions assessed by CT scan'}, {'measure': 'Number of the lesions', 'timeFrame': 'at baseline', 'description': 'Number of cartilage and osteochondral lesions assessed by CT scan'}, {'measure': 'Size of the lesions', 'timeFrame': 'at baseline', 'description': 'Size of cartilage and osteochondral lesions assessed by CT scan'}, {'measure': 'Unstable displaced lesions', 'timeFrame': 'at baseline', 'description': 'Displaced osteochondral fragment in the joint.'}, {'measure': 'Unstable non-displaced lesions', 'timeFrame': 'at baseline', 'description': 'Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cartilage Lesion', 'Osteochondral Lesion', 'Osteochondral Defect', 'Cone Beam arthrogram', 'CBCT arthrogram', 'CT arthrogram', 'Weight bearing CBCT', 'Ankle'], 'conditions': ['Cartilage Lesion', 'Osteochondral Lesion']}, 'referencesModule': {'references': [{'pmid': '33713874', 'type': 'BACKGROUND', 'citation': 'Lopes R, Geffroy L, Padiolleau G, Ngbilo C, Baudrier N, Mainard D, Benoist J, Leiber Wackenheim F, Cordier G, Dubois Ferriere V, Freychet B, Barbier O, Amouyel T. Proposal of a new CT arthrographic classification system of osteochondral lesions of the talus. Orthop Traumatol Surg Res. 2021 Oct;107(6):102890. doi: 10.1016/j.otsr.2021.102890. Epub 2021 Mar 10.'}, {'pmid': '33280057', 'type': 'BACKGROUND', 'citation': 'Grunz JP, Pennig L, Fieber T, Gietzen CH, Heidenreich JF, Huflage H, Gruschwitz P, Kuhl PJ, Petritsch B, Kosmala A, Bley TA, Gassenmaier T. Twin robotic x-ray system in small bone and joint trauma: impact of cone-beam computed tomography on treatment decisions. Eur Radiol. 2021 Jun;31(6):3600-3609. doi: 10.1007/s00330-020-07563-5. Epub 2020 Dec 5.'}, {'pmid': '33798932', 'type': 'BACKGROUND', 'citation': 'Broos M, Berardo S, Dobbe JGG, Maas M, Streekstra GJ, Wellenberg RHH. Geometric 3D analyses of the foot and ankle using weight-bearing and non weight-bearing cone-beam CT images: The new standard? Eur J Radiol. 2021 May;138:109674. doi: 10.1016/j.ejrad.2021.109674. Epub 2021 Mar 20.'}, {'pmid': '30498800', 'type': 'BACKGROUND', 'citation': 'Posadzy M, Desimpel J, Vanhoenacker F. Staging of Osteochondral Lesions of the Talus: MRI and Cone Beam CT. J Belg Soc Radiol. 2017 Dec 16;101(Suppl 2):1. doi: 10.5334/jbr-btr.1377.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare weight-bearing Cone Beam CT arthrogram and conventional CT arthrogram in assessement of patients with ankle osteo-chondral or cartilage lesions.', 'detailedDescription': 'Weight-bearing Cone Beam CT (CBCT) arthrogram, a technique with less radiation dose than conventional CT, is hypothesized non-inferior to conventional CT arthrogram to diagnose osteo-chondral (OCL) or cartilage lesions of the ankle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 18 years;\n* Patients require CT arthrogram of the ankle;\n* Affiliated to a social security schema;\n* Informed consent signed by patients.\n\nExclusion Criteria:\n\n* Pregnant women;\n* Impossibility of injection of intra-articular contrast product;\n* Hypersensitivity reactions to iodinated contrast agent;\n* Patient refusal;\n* Patient under french AME scheme;\n* Patient under guardianship by tutor or curator.'}, 'identificationModule': {'nctId': 'NCT05203757', 'acronym': 'Arthro-CBCT', 'briefTitle': 'Cone Beam CT (CBCT) Arthrogram of the Ankle in Assessement of Osteochondral or Cartilage Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Weight-Bearing Cone Beam CT Arthrogram of the Ankle: a Lower Radiation Dose Technique to Evaluate Osteo-chondral Lesions or Cartilage Lesions: Is it the Future of the arthroCT?', 'orgStudyIdInfo': {'id': 'APHP211118'}, 'secondaryIdInfos': [{'id': '021-A01771-40', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional CT-arthrogram + CBCT arthrogram', 'description': 'Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram).\n\nRoutine care (arthroCT) and CBCT of ankle.', 'interventionNames': ['Procedure: ArthroCT scan', 'Procedure: CBCT']}], 'interventions': [{'name': 'ArthroCT scan', 'type': 'PROCEDURE', 'description': 'Conventional CT arthrogram as routine care', 'armGroupLabels': ['Conventional CT-arthrogram + CBCT arthrogram']}, {'name': 'CBCT', 'type': 'PROCEDURE', 'description': 'Cone Beam CT scan.', 'armGroupLabels': ['Conventional CT-arthrogram + CBCT arthrogram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Radiological department, Raymond Poincaré hospital, APHP', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Mickael TORDJMAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiological department - Raymond Poincaré hospital - APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}