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

Unity Health Toronto

Status: Unknown

Conditions: Rotator Cuff Tear

Treatments: Procedure: Surgical repair of the rotator cuff

Study type: Observational

Funder types: Other

Identifiers

NCT03018210

IMPROVE_2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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