Rotator Cuff TearIMPROVENCT03018210
The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff
An observational study of Rotator Cuff Tear, run by Unity Health Toronto at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Surgical repair of the rotator cuff
- Type of treatment
- Surgery or procedure
- How many people
- 267 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2017to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
John Theodoropoulos, MD, FRCSC
John Theodoropoulos, MD, FRCSC
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Patrick Henry, MD, FRCSC
Patrick Henry, MD, FRCSC
- Not yet recruiting
Toronto Western Hospital
Toronto, Ontario
Christian Veillette, MD, FRCSC
Christian Veillette, MD, FRCSC
- Recruiting
Women's College Hospital
Toronto, Ontario
Jas Chahal, MD, FRCSC
Jas Chahal, MD, FRCSC
- Recruiting
St. Michael's Hospital
Toronto, M5C 1R6
Milena Vicente, RN, 416-864-6060 ext. 2608, vicentem@smh.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Surgical repair of the rotator cuff
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repair of the rotator cuffProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year following surgery
Secondary outcomes (1)
Constant Murley Score
Measured: 1 year following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Nauth, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018210
- Sponsor's protocol ID
- IMPROVE_2017
- Acronym
- IMPROVE
- Status last verified
- Jun 2021
- First submitted
- 10 Jan 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff Tears: a Prospective Cohort
- ClinicalTrials.gov ID
- NCT03018210
- Acronym / sponsor ID
- IMPROVE / IMPROVE_2017
- Conditions
- Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical repair of the rotator cuff | Procedure or surgery | – |
Primary outcome
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 secondary outcome
Constant Murley Score
Time frame: 1 year following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Nauth, MD, FRCSC principal investigator
Unity Health Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Unity Health Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milena Vicente, RN (416-864-6060 ext. 2608, vicentem@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (WORC) (time frame: 1 year following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.