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

June 16, 2021 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Milena Vicente, RN
  • Phone Number: 2608 416-864-6060
  • Email: vicentem@smh.ca

Study Contact Backup

  • Name: Christine Schemitsch, BSc
  • Phone Number: 2608 416-864-6060
  • Email: schemitschc@smh.ca

Study Locations

  • Canada
      • Toronto, Canada, M5C 1R6
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Milena Vicente, RN
          • Phone Number: 2608 416-864-6060
          • Email: vicentem@smh.ca
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • John Theodoropoulos, MD, FRCSC
        • Principal Investigator:
          • John Theodoropoulos, MD, FRCSC
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
          • Patrick Henry, MD, FRCSC
        • Principal Investigator:
          • Patrick Henry, MD, FRCSC
      • Toronto, Ontario, Canada
        • Recruiting
        • Women's College Hospital
        • Contact:
          • Jas Chahal, MD, FRCSC
        • Principal Investigator:
          • Jas Chahal, MD, FRCSC
        • Sub-Investigator:
          • Timothy Dwyer, MD, FRCSC
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Toronto Western Hospital
        • Contact:
          • Christian Veillette, MD, FRCSC
        • Principal Investigator:
          • Christian Veillette, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year following surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Constant Murley Score
Time Frame: 1 year following surgery
1 year following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPROVE_2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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