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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Orthopaedic Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the clinic with rotator cuff tears.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity/specificity of symptoms and physical exam (compared with MRI and expert clinicians' diagnosis)	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.	24 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Brigham and Women's Hospital; University of Texas; Orthopedic Institute, Sioux Falls, SD
• Investigators: Principal Investigator: Nitin B Jain, MD, MSPH, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimated): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 140857; K23AR059199 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No