Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-28 @ 3:32 AM
Study NCT ID:
NCT01532492
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2012-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
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': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the WORC', 'timeFrame': '6 months', 'description': 'Reliability of the WORC is tested by comparing the results at T0 with T1. T1 is planned 2-3 weeks after T0, because we expect that the symptoms do not change between these two moments and the time span is large enough to forget initial responses to the questions. In order to signal change in severity of the symptoms, at both moments patients are asked to rate their shoulder hindrance. To determine test-retest reliability, intraclass correlation coefficients (ICC) are used.'}], 'secondaryOutcomes': [{'measure': 'Criterion validity of the WORC', 'timeFrame': '6 months', 'description': 'Criterion validity is measured by comparing WORC with a general quality of life questionnaire (SF-36) and a commonly used clinical shoulder score (Constant Score) both at T0 and T1. Bland Altman plots will be used to estimate 95% boundaries of concurrence.'}, {'measure': 'Responsiveness of the WORC', 'timeFrame': '6 months', 'description': 'Responsiveness will be determined by calculating the standardized response means and effect sizes on T0 and T2 scores on WORC, SF-36 and Constant scores for the subgroups.'}, {'measure': 'Differentiation between patient groups', 'timeFrame': '6 months', 'description': "A comparison of WORC scores between the three distinct groups is made, to see whether WORC scores can differentiate between them. WORC scores will be compared with SF-36 to investigate whether the noted differences correlate with notable clinical differences and can be expressed as MCID's (minimal clinical important differences)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Questionnaire', 'WORC', 'Rotator cuff', 'Reliability', 'Validity', 'Responsiveness'], 'conditions': ['Rotator Cuff Lesion', 'Disorder of Rotator Cuff', 'Other Instability, Shoulder']}, 'referencesModule': {'references': [{'pmid': '24359231', 'type': 'DERIVED', 'citation': 'Wessel RN, Wolterbeek N, Fermont AJ, van Mameren H, Sonneveld H, Griffin S, de Bie RA. The conceptually equivalent Dutch version of the Western Ontario Rotator Cuff Index (WORC)(c). BMC Musculoskelet Disord. 2013 Dec 21;14:362. doi: 10.1186/1471-2474-14-362.'}]}, 'descriptionModule': {'briefSummary': "Arthroscopic rotator cuff repair is described as being a successful procedure. These results are often derived from clinical general shoulder examinations, which are then classified as 'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications vary and sometimes modified scores are used.\n\nArthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease specific health-related quality of life patient-administered questionnaires are needed. The WORC is a quality of life questionnaire designed for patients with disorders of the rotator cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair specifically.\n\nThe aim of this study is to investigate reliability, validity and responsiveness of WORC in patients undergoing arthroscopic rotator cuff repair.", 'detailedDescription': 'An approved translation of the WORC into Dutch is used. In this prospective study three groups of patients are used: 1.Arthroscopic rotator cuff repair; 2.Disorders of the rotator cuff without rupture; 3.Shoulder instability.\n\nThe WORC, SF-36 and the Constant Score are obtained twice before therapy is started to measure reliability and validity. Responsiveness is tested by obtaining the same tests after therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients undergoing arthroscopic rotator cuff repair. These patients have a clinical suspicion of a symptomatic rotator cuff tear and a partial or full thickness lesion seen on MRI or Ultrasound and confirmed during the arthroscopic repair procedure.\n2. Patients diagnosed as having non-Ruptured DRC. They have a clinical suspicion of DRC and no rupture of the rotator cuff on MRI or Ultrasound.\n3. Patients will be diagnosed with shoulder instability', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* written informed consent\n* diagnosis for group 1, 2 or 3\n\nExclusion Criteria:\n\n* lack of understanding the Dutch language\n* not able to complete questionnaires independently\n* additional shoulder pathology like adhesive capsulitis, AC-pathology and osteoarthritis\n* previous shoulder surgery'}, 'identificationModule': {'nctId': 'NCT01532492', 'acronym': 'WORC', 'briefTitle': 'Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair', 'orgStudyIdInfo': {'id': 'LTME/Z-11.19/WORC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rotator cuff repair group', 'description': 'Patients undergoing an arthroscopic rotator cuff repair'}, {'label': 'DRC without rupture', 'description': 'Disorders of the rotator cuff without rupture'}, {'label': 'Shoulder instability', 'description': 'Shoulder instability'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Department of Orthopedics, St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Ronald N Wessel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}, {'name': 'Henk van Mameren, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Epidemiology, Caphri research school, Maastricht University'}, {'name': 'Rob A de Bie, PhD, MA, RPt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Epidemiology, Caphri research school, Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ronald Wessel', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}