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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03018210
Acronym
IMPROVE
Enrollment
267
Registered
2017-01-11
Start date
2017-01-31
Completion date
2023-01-31
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

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.

Interventions

PROCEDURESurgical repair of the rotator cuff

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Western Ontario Rotator Cuff Index (WORC)1 year following surgeryThe 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

MeasureTime frame
Constant Murley Score1 year following surgery

Countries

Canada

Contacts

Primary ContactMilena Vicente, RN
vicentem@smh.ca416-864-6060
Backup ContactChristine Schemitsch, BSc
schemitschc@smh.ca416-864-6060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026