Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04460118
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-04', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-04', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS for pain score', 'timeFrame': '2 years after surgery', 'description': 'The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.'}, {'measure': 'ASES score', 'timeFrame': '2 years after surgery', 'description': "The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints."}], 'secondaryOutcomes': [{'measure': 'Active shoulder ranges of motion', 'timeFrame': '2 years after surgery', 'description': 'internal rotation at the side, and external and internal rotation at 90° of abduction,'}, {'measure': 'Bone block position', 'timeFrame': 'immediately after surgery.', 'description': "Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm."}, {'measure': 'Bone union', 'timeFrame': '3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery', 'description': "Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone was 5 mm or more."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder; Dislocation, Chronic']}, 'descriptionModule': {'briefSummary': 'Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.', 'detailedDescription': 'Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.\n\nPurpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.\n\nStudy Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients undergoing the "Inlay" Bristow surgery in our hospital between June 2015 and February 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a glenoid defect ≥10%\n2. contact sport athletes with a glenoid defect \\< 10%\n3. failure after Bankart repair.\n\nExclusion Criteria:\n\n1. epilepsy\n2. multidirectional shoulder instability\n3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps\n4. Follow-up was less than 2 years or incomplete follow-up data.'}, 'identificationModule': {'nctId': 'NCT04460118', 'briefTitle': 'Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation', 'orgStudyIdInfo': {'id': 'cui1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'screw group', 'description': 'coracoid bone block fixed by the screw', 'interventionNames': ['Procedure: Bristow surgery fixed by the screw']}, {'label': 'button group', 'description': 'coracoid bone block fixed by the suture-button', 'interventionNames': ['Procedure: Bristow surgery fixed by the suture button']}], 'interventions': [{'name': 'Bristow surgery fixed by the screw', 'type': 'PROCEDURE', 'description': 'Bristow surgery fixed by the screw', 'armGroupLabels': ['screw group']}, {'name': 'Bristow surgery fixed by the suture button', 'type': 'PROCEDURE', 'description': 'Bristow surgery fixed by the suture button', 'armGroupLabels': ['button group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'PekingUTH', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Guoqing Cui, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}