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Clinical Trials/NCT03018210
NCT03018210
Unknown
N/A

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

Unity Health Toronto5 sites in 1 country267 target enrollmentJanuary 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rotator Cuff Tear
Sponsor
Unity Health Toronto
Enrollment
267
Locations
5
Primary Endpoint
Western Ontario Rotator Cuff Index (WORC)
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
January 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males and females aged 35-80
  • 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

  • Patients undergoing subacromial decompression alone
  • 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

Outcomes

Primary Outcomes

Western Ontario Rotator Cuff Index (WORC)

Time Frame: 1 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

  • Constant Murley Score(1 year following surgery)

Study Sites (5)

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