The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff
IMPROVE
1 other identifier
observational
267
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 10, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedJune 18, 2021
June 1, 2021
5 years
January 10, 2017
June 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Constant Murley Score
1 year following surgery
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, M5C 1R6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Nauth, MD, FRCSC
Unity Health Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2017
First Posted
January 11, 2017
Study Start
January 1, 2017
Primary Completion
January 1, 2022
Study Completion
January 1, 2023
Last Updated
June 18, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share