Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT04459858
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2020-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Constant Score', 'timeFrame': '1 year (before surgery and 1 year after surgery)', 'description': 'This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately.\n\nThe subjective variables are pain and activity of daily life (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 Points (the higher the score the better the shoulder function).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Shoulder Angle (CSA)', 'Greater Tuberosity Angle (GTA)'], 'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.', 'detailedDescription': 'A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff tears. This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated for traumatic or degenerative rotator cuff lesion at the University Hospital Basel between January 2015 and January 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient after an arthroscopic rotator cuff repair\n* 1 to 4 years postoperative\n* Presence of pre-operative radiography of the shoulder\n\nExclusion Criteria:\n\n* Massive irreparable cuff tear\n* Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic repair\n* Absence of pre-operative radiography in neutral rotation'}, 'identificationModule': {'nctId': 'NCT04459858', 'acronym': 'GTA', 'briefTitle': 'The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'GTA-The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear - a Comparative Study.', 'orgStudyIdInfo': {'id': '2020-01201; ch20Taha2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rotator cuff lesion', 'description': 'patients treated for traumatic or degenerative rotator cuff lesion', 'interventionNames': ['Other: data analysis']}], 'interventions': [{'name': 'data analysis', 'type': 'OTHER', 'description': 'Data is extracted from the existing medical records and from the Rotator Cuff Repair Database (RCR\\_USB). The GTA (determined as the angle between a "line parallel to the humerus diaphysis passing through the humeral head center of rotation and a line connecting the upper border of the humeral head to the most superolateral edge of the greater tuberosity") is determined.', 'armGroupLabels': ['rotator cuff lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Department of Orthopaedics and Traumatology, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Mohy Taha, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics and Traumatology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}