Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT00828256
Status:
UNKNOWN
Last Update Posted:
2009-01-23
First Post:
2009-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D022125', 'term': 'Lacerations'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-22', 'studyFirstSubmitDate': '2009-01-22', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evidence of an anatomic repair of the rotator cuff proved by ultrasound', 'timeFrame': 'immidiate'}], 'secondaryOutcomes': [{'measure': 'high constant score', 'timeFrame': '6 months after surgery'}]}, 'conditionsModule': {'keywords': ['arthroscopic repair', 'rotator cuff', 'tears', 'shoulder', 'chronic tear of rotator cuff'], 'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears in the last decade. Many researches demonstrate equal and even superior outcome with this surgical technique, while others show opposite results.\n\nThe aim of this study is to estimate the anatomic and functional results of the arthroscopic repair among the patients of the orthopedic department at the Soroka University Medical Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair of the rotator cuff is the better surgical technique.\n\nMethods: study population - 80 patients who had had an arthroscopic repair of the rotator cuff between the years 2005-2008 at the SUMC.\n\nInclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation not before 2005.\n\nStudy design:\n\n1. Data base Collection.\n2. Inviting the patients for physical examination + ultrasound examination of the operated shoulder + filling out questionnaires (SF36, CONSTANT SCORE)\n3. Statistical analysis\n4. Publication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 patients, above 18 years of age, who had had an arthroscopic repair of chronic rotator cuff tear between the years 2005-2008.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Arthroscopic repair of chronic rotator cuff tear\n* Operation done after January 2005'}, 'identificationModule': {'nctId': 'NCT00828256', 'briefTitle': 'Outcome of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Outcome Study of Arthroscopic Repair of Chronic Rotator Cuff Tears Between 2005-2008, at the Soroka University Medical Center, Beer Sheva, Israel', 'orgStudyIdInfo': {'id': 'sor477308ctil'}, 'secondaryIdInfos': [{'id': 'isrctn9930305'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'arthroscopy of shoulder', 'type': 'PROCEDURE', 'description': 'arthroscopic repair of chronic rotator cuff tears'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Asaf Acker', 'oldOrganization': 'Soroka University Medical Center, Beer Sheva, Israel'}}}}