Rotator Cuff TearROWNCT02287090
Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial summary
Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Observational Cohort
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to Dec 2024
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the clinic with rotator cuff tears.
Who may be able to join
- Age 45 or older
- Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder
Who cannot join
- History of humeral fractures
- Prior surgery on the same shoulder
- Contraindications to MRI (prior surgical hardware, pacemakers, defibrillators, and claustrophobia)
- Unable or unwilling to give informed consent
- Unable or unwilling to be followed up
- Non-English speaking (as questionnaires have only been validated in English)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Texas Southwestern
Dallas, Texas, 75390
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Orthopaedic Institute
Sioux Falls, South Dakota, 57105
About this study
Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. The investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.
Read the detailed description
Rotator cuff tears account for over one quarter million surgeries annually. They are a leading cause of shoulder pain and disability. Patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. Fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. Prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. As a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. Consequently, clinicians rely heavily on magnetic resonance imaging (MRI) for diagnosing cuff tears, adding considerable expense in the diagnostic process.
The treatment options for rotator cuff tears are operative and non-operative. There is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. Furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears.
We are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.
- Conditions
- Rotator Cuff Tear
- Being tested
- Observational Cohort
- 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.
Observational CohortOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/Function (as measured by the SPADI outcome score)
Comparing patient pain/function [as measured by the Shoulder Pain and Disability Index (SPADI) outcome instrument] between patients undergoing surgery and patients choosing non-operative treatment.
Measured: 24 months
Secondary outcomes (4)
Pain/Function (as measured by the ASES outcome score)
Comparing patient pain/function [as measured by the American Shoulder and Elbow Society (ASES) outcome instrument] between patients undergoing surgery and patients choosing non-operative treatment.
Measured: 24 months
Pain/Function (as measured by the QuickDash outcome score)
Comparing patient pain/function [as measured by the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score] between patients undergoing surgery and patients choosing non-operative treatment.
Measured: 24 months
Effects of rotator cuff tear size on outcomes (as measured by the SPADI outcome instrument).
To determine the effect of rotator cuff size tear (as measured by MRI) on outcome [as measured by the Shoulder Pain and Disability Index (SPADI) outcome instrument], controlling for surgical/non-operative treatment.
Measured: 24 months
Effects of patient age on outcomes (as measured by the SPADI outcome instrument).
To determine if patient age affects their outcome [as measured by the Shoulder Pain and Disability Index (SPADI) outcome instrument], controlling for surgical/non-operative treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2024
- Study completionDec 2024
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 Vanderbilt University Medical CenterThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brigham and Women's Hospital, Orthopedic Institute, Sioux Falls, SD, University of Texas
- Responsible party
- Principal investigator, Nitin Jain, Vanderbilt University
- Investigators
- Nitin B Jain, MD, MSPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287090
- Sponsor's protocol ID
- 140857
- Other IDs
- K23AR059199
- Acronym
- ROW
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2014
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT02287090
- Acronym / sponsor ID
- ROW / 140857
- Conditions
- Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brigham and Women's Hospital, Orthopedic Institute, Sioux Falls, SD, University of Texas
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 10 Nov 2014 (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.
Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. The investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.
Detailed description
Rotator cuff tears account for over one quarter million surgeries annually. They are a leading cause of shoulder pain and disability. Patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. Fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. Prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. As a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. Consequently, clinicians rely heavily on magnetic resonance imaging (MRI) for diagnosing cuff tears, adding considerable expense in the diagnostic process.
The treatment options for rotator cuff tears are operative and non-operative. There is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. Furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears.
We are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the clinic with rotator cuff tears.
Key inclusion criteria (2 listed)
- Age 45 or older
- Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder
Key exclusion criteria (6 listed)
- History of humeral fractures
- Prior surgery on the same shoulder
- Contraindications to MRI (prior surgical hardware, pacemakers, defibrillators, and claustrophobia)
- Unable or unwilling to give informed consent
- Unable or unwilling to be followed up
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 |
|---|---|---|
| Observational Cohort | Other | – |
Primary outcome
Pain/Function (as measured by the SPADI outcome score)
Time frame: 24 months
Comparing patient pain/function [as measured by the Shoulder Pain and Disability Index (SPADI) outcome instrument] between patients undergoing surgery and patients choosing non-operative treatment.
4 secondary outcomes
Pain/Function (as measured by the ASES outcome score)
Time frame: 24 months
Pain/Function (as measured by the QuickDash outcome score)
Time frame: 24 months
Effects of rotator cuff tear size on outcomes (as measured by the SPADI outcome instrument).
Time frame: 24 months
Effects of patient age on outcomes (as measured by the SPADI outcome instrument).
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nitin B Jain, MD, MSPH principal investigator
Vanderbilt University
4 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 Vanderbilt University Medical Center at 4 sites in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain/Function (as measured by the SPADI outcome score) (time frame: 24 months). 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 6 Feb 2025.