The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff
NCT ID: NCT03018210
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
267 participants
OBSERVATIONAL
2017-01-31
2023-01-31
Brief Summary
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Detailed Description
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The primary outcome of interest will be the Western Ontario Rotator Cuff Index (WORC) measured at one year following surgery. The WORC is a disease specific, quality of life measurement tool with 21 questions separated into 5 domains: physical symptoms, sports/recreation, work, lifestyle, and emotion. Secondary outcomes of interest will be the Constant Murley Score (CMS), which relies on subjective as well as objective components of scoring, and the EQ-5D-5L which will be used as a general measure of health.
Psychological well-being will be measured using the Patient Health Questionnaire-8 (PHQ-8), the 7-item General Anxiety Disorder scale (GAD-7), the Patient Catastrophizing Scale (PCS) , and the expectations survey from the Musculoskeletal Outcomes Data Evaluation and Management System \[MODEMS\] . Post-operative satisfaction will be measured using the MODEMS satisfaction survey.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Surgical repair of the rotator cuff
Eligibility Criteria
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Inclusion Criteria
* Symptomatic, full-thickness tear of the rotator cuff, confirmed by MRI examination
* Patients undergoing rotator cuff repair
* Symptoms must have been present for 3 or more months
Exclusion Criteria
* Glenohumeral arthritis of Grade 2 or higher
* Patients undergoing revision surgery
* Patients receiving Workplace Safety and Insurance Board (WSIB) benefits
* Neurologic disorder affecting the upper extremity
* Injury to the rotator cuff sustained as a result of polytrauma, or any other significant injuries sustained that the treating surgeon believes will have an effect on the recovery from rotator cuff repair surgery
* Patients involved in a legal case/proceedings or seeking legal advice related to the injury sustained to the rotator cuff
35 Years
80 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Aaron Nauth, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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John Theodoropoulos, MD, FRCSC
Role: primary
Patrick Henry, MD, FRCSC
Role: primary
Christian Veillette, MD, FRCSC
Role: primary
Jas Chahal, MD, FRCSC
Role: primary
Other Identifiers
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IMPROVE_2017
Identifier Type: -
Identifier Source: org_study_id
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