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NCT Number: NCT02287090

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

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observational Cohort

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Brigham and Women's Hospital
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Orthopedic Institute, Sioux Falls, SD
  • University of Texas

Registry information

Acronym: ROW

Important dates

Study start
2011
Primary completion
2024
Study completion
2024
First posted
Nov 10, 2014
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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