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

June 16, 2021 updated by: Unity Health Toronto

The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff Tears: a Prospective Cohort

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Milena Vicente, RN
  • Phone Number: 2608 416-864-6060
  • Email: vicentem@smh.ca

Study Contact Backup

  • Name: Christine Schemitsch, BSc
  • Phone Number: 2608 416-864-6060
  • Email: schemitschc@smh.ca

Study Locations

  • Canada
      • Toronto, Canada, M5C 1R6
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Milena Vicente, RN
          • Phone Number: 2608 416-864-6060
          • Email: vicentem@smh.ca
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • John Theodoropoulos, MD, FRCSC
        • Principal Investigator:
          • John Theodoropoulos, MD, FRCSC
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
          • Patrick Henry, MD, FRCSC
        • Principal Investigator:
          • Patrick Henry, MD, FRCSC
      • Toronto, Ontario, Canada
        • Recruiting
        • Women's College Hospital
        • Contact:
          • Jas Chahal, MD, FRCSC
        • Principal Investigator:
          • Jas Chahal, MD, FRCSC
        • Sub-Investigator:
          • Timothy Dwyer, MD, FRCSC
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Toronto Western Hospital
        • Contact:
          • Christian Veillette, MD, FRCSC
        • Principal Investigator:
          • Christian Veillette, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Western Ontario Rotator Cuff Index (WORC)
Time Frame: 1 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.
1 year following surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Constant Murley Score
Time Frame: 1 year following surgery
1 year following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMPROVE_2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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