Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-07 @ 7:39 AM
Study NCT ID:
NCT03654118
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Review of a Cohort of Arthroscopic Bankart Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of instability recurrence after arthroscopic Bankart intervention', 'timeFrame': 'Through study completion, 2 months on average', 'description': "The rate of instability recurrence 9 years after an arthroscopic Bankart intervention, is derived from the patient's responses to the interview"}], 'secondaryOutcomes': [{'measure': 'Predictive value of the ISIS score in the occurrence of recurrence of instability', 'timeFrame': 'Through study completion, 2 months on average'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthroscopy', 'Bankart', 'Shoulder', 'ISIS'], 'conditions': ['Recurrent Anterior Shoulder Instability']}, 'descriptionModule': {'briefSummary': "Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.\n\nSurgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).\n\nLike in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.\n\nBankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.\n\nThe determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.\n\nThe aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* Patient who already volunteered in a first ISIS study\n\nInclusion Criteria of the ISIS Study:\n\n* Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of the indication of operation an ISIS score of ≤ 4 points (regardless of the positive criteria) (see Annex 2- ISIS score)\n* Age\\> 16 years\n* Supported by a joint arthroscopic technique completed.\n* Patient not objecting to his participation in the study\n\nExclusion Criteria (same as those of the ISIS study)\n\n* First dislocation or resumption of another technique at the time of indication for surgery\n* Voluntary or multidirectional instability at the time of the indication of operation\n* Painful shoulder without instability felt at the time of the operative indication\n* Lesion of the cap (perioperative report)\n* Humeral lesions Avulsion Gleno-humeral Ligament (per-operative finding)\n* Unsuccessful technique\n* Major benefiting from a legal protection measure (safeguard of justice, trusteeship, guardianship)'}, 'identificationModule': {'nctId': 'NCT03654118', 'acronym': 'ISIS-2017', 'briefTitle': 'Long-term Review of a Cohort of Arthroscopic Bankart Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Long-term Review of a Cohort of Arthroscopic Bankart Interventions', 'orgStudyIdInfo': {'id': '35RC17_3025'}, 'secondaryIdInfos': [{'id': '2017-A01665-48', 'type': 'OTHER', 'domain': 'Id-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ISIS cohort', 'description': 'Patients operated between December 2007 and December 2008 for recurrent shoulder instability using the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of indication for surgery an ISIS score ≤ 4 points\n\nPhone follow-up', 'interventionNames': ['Other: Phone follow-up']}], 'interventions': [{'name': 'Phone follow-up', 'type': 'OTHER', 'description': 'Through a short phone interview :\n\n* Determination of a complication (Infection, capsulitis, recurrence)\n* Determination of the Rowe score\n* Determination of the Walch-Duplay score', 'armGroupLabels': ['ISIS cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique parc Rambot Provençale', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '74000', 'city': 'Annecy', 'country': 'France', 'facility': "Clinique Générale d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '59400', 'city': 'Cambrai', 'country': 'France', 'facility': 'Clinique du Cambresis', 'geoPoint': {'lat': 50.17596, 'lon': 3.23472}}, {'zip': '38432', 'city': 'Échirolles', 'country': 'France', 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '76600', 'city': 'Le Havre', 'country': 'France', 'facility': 'Clinique François 1er', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '33700', 'city': 'Mérignac', 'country': 'France', 'facility': 'Clinique du Sport de Bordeaux-Mérignac', 'geoPoint': {'lat': 44.84247, 'lon': -0.64512}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Archet II', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Antoine / APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75008', 'city': 'Paris', 'country': 'France', 'facility': 'Clinique Turin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de RENNES', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Hervé THOMAZEAU, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rennes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}