Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT02725320
Status:
UNKNOWN
Last Update Posted:
2019-04-26
First Post:
2016-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rotator Cuff Surgical Outcomes in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-03-27', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario Rotator Cuff score (WORC)', 'timeFrame': '1 year', 'description': 'WORC scores will be compared at 12 months between the groups (males versus females)'}], 'secondaryOutcomes': [{'measure': 'Overall change in WORC (male versus female)', 'timeFrame': '1 year', 'description': 'Evaluation of the overall change in WORC score by gender'}, {'measure': 'Rate of change in WORC (male versus female)', 'timeFrame': '1 year', 'description': 'Evaluation of the rate of change in WORC score over 1 year between male and female'}, {'measure': 'Rate of change in visual analogue scale (VAS) (male versus female)', 'timeFrame': '1 year', 'description': 'Evaluation of the rate of change in VAS score over 1 year between male and female'}, {'measure': 'Rate of change in SF-36 (short-form 36) response scores (male versus female)', 'timeFrame': '1 year', 'description': 'Evaluation of the rate of change in SF-36 scores over 1 year between male and female'}, {'measure': 'Rate of change of satisfaction with surgical outcome (male versus female)', 'timeFrame': '1 year', 'description': 'Evaluation of the rate of change in satisfaction with surgical outcome between male and female over 1 year'}, {'measure': 'Prevalence of anxiety and depression at baseline', 'timeFrame': 'Baseline data', 'description': 'Evaluation of the HADS (Hospital Anxiety and Depression Scale) at baseline to determine the prevalence of mood disorder'}, {'measure': 'Prevalence of catastrophizing at baseline', 'timeFrame': 'Baseline data', 'description': 'Evaluation of the PCS (Pain Catastrophizing Score) at baseline to determine the prevalence catastrophizing'}, {'measure': 'Improvement in HADS', 'timeFrame': '1 year', 'description': 'Evaluation of HADS scores over 1 year to determine improvement from baseline'}, {'measure': 'Height (males versus females)', 'timeFrame': 'baseline', 'description': 'Evaluation of the difference in height between genders'}, {'measure': 'Change in reach over time', 'timeFrame': '1 year', 'description': 'Evaluation of forward reach to determine the change from baseline to one year'}, {'measure': 'WORC score by HADS score', 'timeFrame': '1 year'}, {'measure': 'WORC score by PCS score', 'timeFrame': '1 year'}, {'measure': 'WORC score by forward reach', 'timeFrame': '1 year'}, {'measure': 'WORC score correlated to gender, PCS, HADS', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rotator cuff', 'shoulder reconstruction'], 'conditions': ['Injury of Shoulder Region', 'Rotator Cuff Syndrome']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this work is to use a prospective cohort study to examine patient-specific but shoulder-extrinsic factors and how they influence the results of rotator cuff surgery. There are undoubtedly many factors that play a role in patient outcome, however, this project will focus on three: the effect of gender on outcome, the effect of mood disorders and coping style on outcome, and the effect of patient height and reach on outcome after rotator cuff surgery. It is hypothesized that these factors will have a significant influence over outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants for this study will be selected from the practice of three shoulder reconstruction surgeons in their embedded clinical research practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for surgical treatment of predominantly unilateral rotator cuff syndrome\n\nExclusion Criteria:\n\n* unable to speak or read English\n* unable to complete 12 month follow-up\n* significant cervicogenic arm and shoulder pain in the affected arm\n* significant chronic pain diagnoses felt at least as likely to be the cause of the symptoms as the rotator cuff condition as evaluated by the surgeon'}, 'identificationModule': {'nctId': 'NCT02725320', 'acronym': 'RCSOW', 'briefTitle': 'Rotator Cuff Surgical Outcomes in Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Rotator Cuff Surgical Outcomes in Women', 'orgStudyIdInfo': {'id': 'REB15-1229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female Rotator Cuff Surgical Group', 'description': 'Females, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome'}, {'label': 'Male Rotator Cuff Surgical Group', 'description': 'Males, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'South Health Campus', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Marlis Sabo, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Marlis Sabo', 'investigatorAffiliation': 'University of Calgary'}}}}