Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 8:23 PM
Study NCT ID:
NCT01805050
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Study: HAGL-lesion (HAGL:Humeral Avulsion Glenohumeral Ligament)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2013-03-04', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOSI-Score', 'timeFrame': 'expected average of 2 years'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic Dates', 'timeFrame': 'expected average of 2 years'}, {'measure': 'x-ray images', 'timeFrame': 'expected average of 2 years'}, {'measure': 'Constant-Murley Score', 'timeFrame': 'expected average of 2 years'}, {'measure': 'Rowe - Score', 'timeFrame': 'expected average of 2 years'}, {'measure': 'SSV (Simple Shoulder Value)', 'timeFrame': 'expected average of 2 years'}, {'measure': 'SST (Simple Shoulder Test)', 'timeFrame': 'expected average of 2 years'}, {'measure': 'Measurement of the abduction strength', 'timeFrame': 'expected average of 2 years'}, {'measure': 'Measurement of the external rotation strength', 'timeFrame': 'expected average of 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HAGL', 'Shoulder instability'], 'conditions': ['Shoulder Injuries and Disorders']}, 'descriptionModule': {'briefSummary': 'This study shows a new technique which has been implemented at the schulthess clinic to improve the outcome after an correction of an anterior instability in the shoulder joint due to a HAGL lesion.', 'detailedDescription': 'The aim of the study is to describe and document the results of a case serie after an arthroscopically intervention to correct the anterior instability in the shoulder joint with one primary parameter (WOSI-Score) and several secondary parameters, which are used in the daily clinical routine (e.g.clinical examination, several questionnaires). The results of these parameters will be used to document the mid-term results (\\> 1 year after surgery).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent surgical repair of the anterior instability due an HAGL lesion at the Schulthess Klinik and have been performed surgery by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* arthroscopically repair of the anterior instability of the shoulder due an HAGL lesion (performed by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey at the Schulthess Klinik)\n* patients ≥18 years\n* written informed consent\n\nExclusion Criteria:\n\n* additional surgeries at the affected side after the index surgery (arthroscopically repair of the anterior instability due an HAGL lesion)\n* non-compliance\n* disorders which handicap or inhibit the patient to follow the orders of the clinical testers\n* request of the patient'}, 'identificationModule': {'nctId': 'NCT01805050', 'briefTitle': 'Case Study: HAGL-lesion (HAGL:Humeral Avulsion Glenohumeral Ligament)', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Arthroscopically Repair of the Anterior Instability of the Shoulder Due an HAGL - Lesion - A Case Serie', 'orgStudyIdInfo': {'id': 'HAGL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New Technique', 'description': 'All patients who underwent surgical repair of the anterior instability due an HAGL lesion.', 'interventionNames': ['Procedure: Arthroscopically repair of the anterior shoulder instability']}], 'interventions': [{'name': 'Arthroscopically repair of the anterior shoulder instability', 'type': 'PROCEDURE', 'description': 'Arthroscopically repair of the anterior shoulder instability', 'armGroupLabels': ['New Technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'state': 'Canton of Zürich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Matthias Flury, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Upper Extremities Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator (Department of Upper Extremity)', 'investigatorFullName': 'Matthias Flury', 'investigatorAffiliation': 'Schulthess Klinik'}}}}