Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-04-12 @ 5:47 AM
Study NCT ID:
NCT02401568
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2015-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphologic and Biomechanical Analysis of the Carpal Ligaments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007593', 'term': 'Joint Instability'}, {'id': 'D014954', 'term': 'Wrist Injuries'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-27', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scapholunate diastasis (mm)', 'timeFrame': '1 day', 'description': 'The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed'}, {'measure': 'Scapholunate angle', 'timeFrame': '1 day', 'description': 'the variation in the scapholunate angle during the maneuvers performed will be assessed'}, {'measure': 'Lunocapitate angle', 'timeFrame': '1 day', 'description': 'the variation in the lunocapitate angle during the maneuvers performed will be assessed'}, {'measure': 'Posterior radio scaphoid angle', 'timeFrame': '1 Day', 'description': 'The angle formed between the posterior most point of the scaphoid in the sagittal plane and the ventral and dorsal rims of the distal radius will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Joint Instability', 'Wrist Injuries']}, 'referencesModule': {'references': [{'pmid': '25656096', 'type': 'BACKGROUND', 'citation': 'Gondim Teixeira PA, Gervaise A, Louis M, Lecocq S, Raymond A, Aptel S, Blum A. Musculoskeletal wide detector CT: principles, techniques and applications in clinical practice and research. Eur J Radiol. 2015 May;84(5):892-900. doi: 10.1016/j.ejrad.2014.12.033. Epub 2015 Jan 17.'}, {'pmid': '23571486', 'type': 'BACKGROUND', 'citation': 'Garcia-Elias M, Alomar Serrallach X, Monill Serra J. Dart-throwing motion in patients with scapholunate instability: a dynamic four-dimensional computed tomography study. J Hand Surg Eur Vol. 2014 May;39(4):346-52. doi: 10.1177/1753193413484630. Epub 2013 Apr 8.'}, {'pmid': '22137722', 'type': 'BACKGROUND', 'citation': 'Halpenny D, Courtney K, Torreggiani WC. Dynamic four-dimensional 320 section CT and carpal bone injury - a description of a novel technique to diagnose scapholunate instability. Clin Radiol. 2012 Feb;67(2):185-7. doi: 10.1016/j.crad.2011.10.002. Epub 2011 Dec 3. No abstract available.'}, {'pmid': '23863544', 'type': 'BACKGROUND', 'citation': 'Troupis JM, Amis B. Four-dimensional computed tomography and trigger lunate syndrome. J Comput Assist Tomogr. 2013 Jul-Aug;37(4):639-43. doi: 10.1097/RCT.0b013e31828b68ec.'}, {'pmid': '37698480', 'type': 'DERIVED', 'citation': 'Orkut S, Gillet R, Granero J, Hossu G, Douis N, Athlani L, Blum A, Gondim Teixeira PA. Assessment of Scapholunate Instability on 4D CT Scans in Patients with Inconclusive Conventional Images. Radiology. 2023 Sep;308(3):e230193. doi: 10.1148/radiol.230193.'}]}, 'descriptionModule': {'briefSummary': 'Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.', 'detailedDescription': 'Patients referred for the evaluation of wrist pain with CT arthrography will be eligible for inclusion. Patients will benefit from dynamic CT acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. Patients will also benefit from a wrist MR study on a 3 tesla scanner.\n\nThe morphology of the carpal ligaments will be evaluated on static imaging (MR and CT arthrograph) and on dynamic CT arthrography.\n\nDistance and angular measurements will be obtained from dynamic CT studies using an appropriate post processing tool (4D-Ortho).\n\nData obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical signs of wrist instability or wrist pain\n* Previous medical examination\n* Informed consent\n* Must have a social security number\n\nExclusion Criteria:\n\n* MR or CT contra-indications\n* No prior surgery\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02401568', 'acronym': 'EDLIS', 'briefTitle': 'Morphologic and Biomechanical Analysis of the Carpal Ligaments', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT', 'orgStudyIdInfo': {'id': '2014-A00845-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Normal subjects', 'description': 'No morphologic changes in carpal ligaments or clinical signs of wrist instability.\n\nDynamic CT of the wrist will be performed before and after arthrography.', 'interventionNames': ['Device: Dynamic CT', 'Procedure: Arthrography']}, {'type': 'OTHER', 'label': 'Wrist instability', 'description': 'Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.', 'interventionNames': ['Device: Dynamic CT', 'Procedure: Arthrography']}], 'interventions': [{'name': 'Dynamic CT', 'type': 'DEVICE', 'description': 'Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion).', 'armGroupLabels': ['Normal subjects', 'Wrist instability']}, {'name': 'Arthrography', 'type': 'PROCEDURE', 'description': 'percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints', 'armGroupLabels': ['Normal subjects', 'Wrist instability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'CentralHNF', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Alain Blum, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}