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

NCT02287090 | Completed

• 2 other identifiers: 140857K23AR059199
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain/Function (as measured by the ASES outcome score)

  24 months

• Pain/Function (as measured by the QuickDash outcome score)

  24 months

• Effects of rotator cuff tear size on outcomes (as measured by the SPADI outcome instrument).

  24 months

• Effects of patient age on outcomes (as measured by the SPADI outcome instrument).

  24 months

Other Outcomes (1)

• Sensitivity/specificity of symptoms and physical exam (compared with MRI and expert clinicians' diagnosis)

  24 months

Interventions

Observational Cohort OTHER

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the clinic with rotator cuff tears.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Orthopaedic Institute

Sioux Falls, South Dakota, 57105, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Nitin B Jain, MD, MSPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation and Orthopaedics

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 10, 2014
• Study Start: March 1, 2011
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-10

Locations

US (4)