Clinical trial NCT03018210: The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff
Official title: The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff Tears: a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tear
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 267
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 1 year following surgery
Secondary outcomes:
measure: Constant Murley Score
timeFrame: 1 year following surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
Study officials:
affiliation: Unity Health Toronto
name: Aaron Nauth, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: