Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears (ROW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02287090
Recruitment Status : Active, not recruiting
First Posted : November 10, 2014
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Brigham and Women's Hospital
Orthopedic Institute, Sioux Falls, SD
Information provided by (Responsible Party):
Nitin Jain, Vanderbilt University

Brief 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, 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.

Condition or disease Intervention/treatment
Rotator Cuff Tear Other: Observational Cohort

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears
Study Start Date : March 2011
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain/Function (as measured by the ASES outcome score) [ Time Frame: 24 months ]
    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.

  2. Pain/Function (as measured by the QuickDash outcome score) [ Time Frame: 24 months ]
    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.

  3. Effects of rotator cuff tear size on outcomes (as measured by the SPADI outcome instrument). [ Time Frame: 24 months ]
    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.

  4. Effects of patient age on outcomes (as measured by the SPADI outcome instrument). [ Time Frame: 24 months ]
    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.


Other Outcome Measures:
  1. Sensitivity/specificity of symptoms and physical exam (compared with MRI and expert clinicians' diagnosis) [ Time Frame: 24 months ]
    To determine the sensitivity/specificity of symptoms and physical examination as compared with MRI and expert clinicians' diagnosis for the detection of rotator cuff tears.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the clinic with rotator cuff tears.
Criteria

Inclusion Criteria:

  • Age 45 or older
  • Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287090


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, South Dakota
Orthopaedic Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Brigham and Women's Hospital
Orthopedic Institute, Sioux Falls, SD
Investigators
Layout table for investigator information
Principal Investigator: Nitin B Jain, MD, MSPH Vanderbilt University

Layout table for additonal information
Responsible Party: Nitin Jain, Associate Professor of Physical Medicine and Rehabilitation and Orthopaedics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02287090     History of Changes
Other Study ID Numbers: 140857
K23AR059199 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries