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

Rotator Cuff Tear Clinical Trial

— ROW  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02287090
• Other study ID #: 140857
• Secondary ID: K23AR059199
• Status: Active, not recruiting
• Start date: March 2011
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Other:
• Observational Cohort

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Texas Southwestern	Dallas	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Orthopaedic Institute	Sioux Falls	South Dakota

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Brigham and Women's Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Orthopedic Institute, Sioux Falls, SD, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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