Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-31 @ 7:36 AM
Study NCT ID:
NCT02505932
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007593', 'term': 'Joint Instability'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)", 'timeFrame': 'Average during the first week'}], 'secondaryOutcomes': [{'measure': 'Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)', 'timeFrame': 'Daily from day1 to day7'}, {'measure': 'analgesic consumption (Number of pills)', 'timeFrame': 'Daily from day1 to day7'}, {'measure': 'presence of postoperative discomfort symptoms (yes/no)', 'timeFrame': 'Daily from day1 to day7', 'description': 'The presence (yes/no) of incision site pain, nausea, vomiting, vertigo, anxiety'}, {'measure': 'coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan', 'timeFrame': 'Between 3 to 6 months follow-up'}, {'measure': 'Recurrence rate of shoulder instability (number of recurrence/total number of patients)', 'timeFrame': '2-year minimal follow-up'}, {'measure': 'Functional evaluation of patients', 'timeFrame': '2-year minimal follow-up', 'description': 'Western Ontario Score Index (WOSI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shoulder instability'], 'conditions': ['Joint Instability']}, 'descriptionModule': {'briefSummary': 'To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.', 'detailedDescription': 'This prospective comparative study was performed at two centers in 2012. Each center performed one procedure so this study was observational. All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score\\>3) were included. The Latarjet procedure was performed by mini-open approach (set Arthrex, Naples, FL) in the first group, and by arthroscopic approach (set Depuy-Mitek, Raynham, MA) in the second group. The analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score\\>3)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic anterior instability requiring bone grafting (Instability Severity Index Score\\>3)\n\nExclusion Criteria:\n\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02505932', 'acronym': 'Latarjet', 'briefTitle': 'Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Ambroise Paré Paris'}, 'officialTitle': 'Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up', 'orgStudyIdInfo': {'id': 'APR012012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arthroscopic Latarjet procedure', 'description': 'arthroscopic approach (set Depuy-Mitek, Raynham, MA)', 'interventionNames': ['Procedure: Arthroscopic Latarjet procedure']}, {'label': 'Mini-open Latarjet procedure', 'description': 'mini-open approach (set Arthrex, Naples, FL)', 'interventionNames': ['Procedure: Mini-open Latarjet procedure']}], 'interventions': [{'name': 'Arthroscopic Latarjet procedure', 'type': 'PROCEDURE', 'description': 'arthroscopic approach (set Depuy-Mitek, Raynham, MA)', 'armGroupLabels': ['Arthroscopic Latarjet procedure']}, {'name': 'Mini-open Latarjet procedure', 'type': 'PROCEDURE', 'description': 'mini-open approach (set Arthrex, Naples, FL)', 'armGroupLabels': ['Mini-open Latarjet procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92000', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hospital Ambroise Paré Paris', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'city': 'Paris', 'country': 'France', 'facility': 'Clinique des Maussins', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Shahnaz Klouche, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Ambroise Paré Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Ambroise Paré Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician responsible of clinical research', 'investigatorFullName': 'Shahnaz Klouche, MD', 'investigatorAffiliation': 'Hospital Ambroise Paré Paris'}}}}