Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-28 @ 3:12 AM
Study NCT ID:
NCT05102357
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-31', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual analog scale for pain, disabilities of the arm, shoulder and hand questionnaire and Patient-Rated Wrist Evaluation scores from baseline and at first year', 'timeFrame': 'Baseline and 1 year', 'description': 'Visual analog scale for pain scored from 0 to 10, disabilities of the arm, shoulder and hand questionnaire scored and Patient-Rated Wrist Evaluation scores from from 0 to 100 were scaled at initial admission, before treatment and at their first year recruitment after treatment for assessment conservative treatment success.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scapholunate interosseous ligament, Extrinsic wrist ligaments, Carpal instability, MRI of wrist, Wrist ligamentous injury,'], 'conditions': ['Scapholunate Ligament Partial Tears']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate scapholunate ligament partial tears regarding tear localization, extrinsic ligament accompaniment in stable wrist and accordingly to scrutinize conservative treatment response.', 'detailedDescription': 'Patients admitted with radial sided wrist pain without carpal instability were retrospectively evaluated. Scapholunate interosseous ligament (SLIOL) tear localization, grade of injury and associated extrinsic ligament injuries were examined on MRI. Patients treated conservatively and recalled at their first year for re-evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '109 of 311 patients admitted with radial sided wrist pain had SLL and/or extrinsic ligament injury on MRI, 49,5% (n:55) were female, 50,5% (n:56) male with mean age 34 ± 10 (age range, 12-67 years).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scapholunate ligament Injury\n* Wrist Extrinsic Ligament Injury\n\nExclusion Criteria:\n\n* Scapholunate Dissociation\n* Radiological and clinical instable wrist\n* Carpal bone fracture\n* MRI imaging artefact'}, 'identificationModule': {'nctId': 'NCT05102357', 'briefTitle': 'Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Retrospective Trial, Scapholunate Ligament Partial Tears in Stable Wrist', 'orgStudyIdInfo': {'id': 'Scapholunate Ligament Tear'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Conservative Treatment (splint)', 'type': 'PROCEDURE', 'description': 'splint 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Başakşehir', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Banu Karaalioğlu', 'geoPoint': {'lat': 41.106, 'lon': 28.791}}], 'overallOfficials': [{'name': 'Adnan Kara', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University Hospital Department of Orthopedics'}, {'name': 'Banu Karaalioğlu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University Hospital Department of Radiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Banu Karaalioglu, MD', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}