Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT03018210

Conditions

Rotator Cuff Tear

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Surgical repair of the rotator cuff

Study Details

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.

Conditions

Rotator Cuff Tear

Study ID

NCT03018210

Start date

Jan, 2017

Status verified date

Jun, 2021

Completion date

Jan, 2023

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

267 participants

Anticipated

Interventions and Outcome Measures

Interventions

Surgical repair of the rotator cuff

Primary outcome measure

  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 1 year following surgery ]

Central Contacts and Locations

Central contacts

Milena Vicente, RN

416-864-6060vicentem@smh.ca

Christine Schemitsch, BSc

416-864-6060schemitschc@smh.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

John Theodoropoulos, MD, FRCSC

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Patrick Henry, MD, FRCSC

Women's College Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Jas Chahal, MD, FRCSC

St. Michael's Hospital

Recruiting

Toronto, Canada, M5C 1R6

Contacts

Milena Vicente, RN

416-864-6060vicentem@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Jun 18, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-06-18.