Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 9:08 AM
Study NCT ID:
NCT06695260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosing Dynamic Scapholunate Instability with Computer Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part 1:\n\nTo assess the normal dynamics of the scapholunate joint in patients without scapholunate instability with CT when the wrist is under loading compared to normal conditions\n\nPart 2:\n\nTo assess the dynamic character of the scapholunate joint in patients with scapholunate instability with CT when the wrist is under loading compared to normal conditions'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-16', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-16', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dorsal radioscaphoid translation', 'timeFrame': 'preop assessment', 'description': 'the translation of the scaphoid due to the instability is measured'}], 'secondaryOutcomes': [{'measure': 'scapholunate distance', 'timeFrame': 'preop assessment', 'description': 'scapholunate distance'}, {'measure': 'scapholunate angle', 'timeFrame': 'preop assessment', 'description': 'scapholunate angle in sagital view'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dynamic', 'scapholunate', 'instability', 'CT'], 'conditions': ['Scapholunate Dissociation']}, 'descriptionModule': {'briefSummary': 'Scapholunate instability can result in debilitating pain, dysfunction, and secondary arthritis. If treatment is required, the instability should ideally be addressed in the dynamic stage, before non-reducible non-repairable deformation occurs. Early diagnosing of instability of the scapholunate joint can be a complex task.\n\nIn this study, the use of computer tomography (CT) scan is evaluatedto reveal the dynamic characteristics of the scapholunate instability. A CT-scan will be performed of the non-stressed wrist and a CT-scan under loading to potentially visualize increase of dorsal scaphoid translation, which is considered as primary cause of dorsoradial radioscaphoid pain in the early stage of scapholunate instability.', 'detailedDescription': 'Part 1: Assessment of the normal scapholunate stability with CT scan with and without loading in patients without symptoms of scapholunate instability\n\n40 patients without scapholunate instability, with normal scaphoid shift test will be included. Radiographs of both wrists will be performed (anteroposterior view in pronation, clenched fist in pronation, ulnar deviation + clenched fist in supination and a sagittal view). Measurements will be the scapholunate, radiolunate, capitolunate angle and the radioscaphoid distance/angle. Then, they will undergo CT scan of both wrists without loading of the wrists (full pronation). Then, a CT scan of both wrists with loading of the wrists (supination, ulnar deviation and clenched fist) will be performed. Segmentation of the CT scans will be performed to be able to compare both CT scans. The measurements will be scapholunate distance, radioscaphoid distance, radiolunate distance, radioscaphoid rotation, radiolunate rotation and scapholunate rotation.\n\nExclusion criteria: \\<18 years, arthritis, previous wrist disorders\n\nPart 2: Assessment of the scapholunate instability with CT scan with and without loading in patients with symptoms of scapholunate instability\n\n40 patients with scapholunate instability, with positive scaphoid shift test will be included. Radiographs of both wrists will be performed (anteroposterior view in pronation, clenched fist in pronation, ulnar deviation + clenched fist in supination and a sagittal view). Measurements will be the scapholunate, radiolunate, capitolunate angle and the radioscaphoid distance/angle. Then, they will undergo CT scan of both wrists without loading of the wrists (full pronation). Then, a CT scan of both wrists with loading of the wrists (supination, ulnar deviation and clenched fist) will be performed. Segmentation of the CT scans will be performed to be able to compare both CT scans. The measurements will be scapholunate distance, radioscaphoid distance, radiolunate distance, radioscaphoid rotation, radiolunate rotation and scapholunate rotation. MRI scan will be performed to reveal the ligament attenuation of the scapholunate complex.\n\nTreatment options will be proposed as usual: conservative (medication, physiotherapy) and surgery (arthroscopic capsuloligamentous repair). If arthroscopy is agreed, arthroscopic assessment of the ligamentous complex will be performed.\n\nCorrelation of the CT findings will be performed with the MRI and arthroscopic findings.\n\nExclusion criteria: \\<18 years, arthritis, previous wrist disorders'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n\nExclusion Criteria:\n\n* Associated fractures or other lesions\n\n * Neurological and severe psychological disorders\n * History of ipsilateral wrist disorders\n * Substance abuse'}, 'identificationModule': {'nctId': 'NCT06695260', 'acronym': 'stressct', 'briefTitle': 'Diagnosing Dynamic Scapholunate Instability with Computer Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Regionaal Ziekenhuis Heilig Hart Tienen'}, 'officialTitle': 'Diagnosing Dynamic Scapholunate Instability with Computer Tomography', 'orgStudyIdInfo': {'id': 'RZ T EC 109'}, 'secondaryIdInfos': [{'id': 'EC 109', 'type': 'OTHER', 'domain': 'RZ Tienen'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with scapholunate instability', 'description': 'to assess the dynamic character of the scapholunate joint in patients with scapholunate instability', 'interventionNames': ['Diagnostic Test: CT scan']}], 'interventions': [{'name': 'CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT will be performed when the wrist is under loading compared to normal conditions. scapholunate kinematics will be examines', 'armGroupLabels': ['patients with scapholunate instability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3370', 'city': 'Boutersem', 'country': 'Belgium', 'facility': 'Regionaal Ziekenhuis Tienen', 'geoPoint': {'lat': 50.84105, 'lon': 4.83367}}], 'centralContacts': [{'name': 'chul ki goorens, medical doctor', 'role': 'CONTACT', 'email': 'cgoorens@msn.com', 'phone': '0032478907124'}, {'name': 'Griet Vandervelpen, medical doctor', 'role': 'CONTACT', 'email': 'griet.vandervelpen@rztienen.be', 'phone': '003216809797'}], 'overallOfficials': [{'name': 'Thierry Scheerlinck, clinical professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionaal Ziekenhuis Heilig Hart Tienen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator, medical doctor', 'investigatorFullName': 'Goorens Chul Ki', 'investigatorAffiliation': 'Regionaal Ziekenhuis Heilig Hart Tienen'}}}}