NCT03018210

The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff

The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff Tears: a Prospective Cohort

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 267 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	Surgical repair of the rotator cuff

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2017-01-11
• Last updated: 2021-06-18

Locations

5 sites across 1 country: Canada