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

Rotator Cuff Tear Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018210
• Other study ID #: IMPROVE_2017
• Status: Recruiting
• Start date: January 2017
• Est. completion date: January 2023

Study information

• Verified date: June 2021
• Source: Unity Health Toronto
• Contact: Milena Vicente, RN
• Phone: 416-864-6060
• Email: vicentem[@]smh.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 267
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• Surgical repair of the rotator cuff

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Constant Murley Score		1 year following surgery