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The proposed study will be a multi-centre, prospective, observational cohort to determine if psychological well-being has an impact on the outcome of surgical repair for rotator cuff tears.
This study will take place at multiple centres across the University of Toronto network.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical repair of the rotator cuff | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | 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. | 1 year following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Murley Score | 1 year following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rotator cuff tears confirmed by Magnetic Resonance Imagining (MRI) findings presenting to the out-patient clinic, examined by the treating surgeon for the clinical need for surgical repair.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milena Vicente, RN | Contact | 416-864-6060 | 2608 | vicentem@smh.ca |
| Christine Schemitsch, BSc | Contact | 416-864-6060 | 2608 | schemitschc@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Aaron Nauth, MD, FRCSC | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | Canada |
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| Toronto Western Hospital | Not yet recruiting | Toronto | Ontario | Canada |
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| Women's College Hospital | Recruiting | Toronto | Ontario | Canada |
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| St. Michael's Hospital | Recruiting | Toronto | M5C 1R6 | Canada |
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