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NCT03295994 Clinical Trial

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

— ARC  

Official title:
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03295994
Other study ID # 171863
Secondary ID 1605-354135U34AR
Status Recruiting
Phase N/A
First received
Last updated
Start date March 19, 2018
Est. completion date June 30, 2025

Study information
Verified date September 2023
Source University of Texas Southwestern Medical Center
Contact Hemangi Dhole, MPH
Phone 2146450059
Email hemangi.dhole@utsouthwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.

Description:

This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline. Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date June 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 84 Years
Eligibility Inclusion Criteria: - Aged =>40 years to <85 years - Shoulder pain and/or loss of range of active motion, strength or function - MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension - Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification - Ability and willingness to provide informed consent Exclusion Criteria: - Primary diagnosis is something other than a rotator cuff tear - History (in last 2 years) of shoulder fracture involving the humeral head on affected side - Previous rotator cuff surgery on affected side - Isolated subscapularis &/or teres minor tear on affected side - Acute rotator cuff tear caused by a severe trauma - Shoulder used as a weight-bearing joint - Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.) - Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD - Grade 4 fatty infiltration of rotator cuff (any tendons) - Candidate for shoulder arthroplasty at baseline - Non-English speaking

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Operative
Arthroscopic rotator cuff surgery followed by physical therapy.
• Non-Operative
Physical therapy (without surgery).

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Johns Hopkins Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States University of Texas Southwestern Dallas Texas
United States University of Colorado - Denver Denver Colorado
United States Western Orthopaedics Denver Colorado
United States University of Iowa Iowa City Iowa
United States Ortho Tennessee - Knoxville Orthopedic Clinic Knoxville Tennessee
United States University of Kentucky Lexington Kentucky
United States Vanderbilt University Medical Center Nashville Tennessee
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Ortho Virginia Richmond Virginia
United States Washington University Saint Louis Missouri
United States University of California - San Francisco (UCSF) San Francisco California
United States Orthopedic Institute Sioux Falls South Dakota

Sponsors (3)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Shoulder Pain & Disability Index (SPADI) SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst. Study participants will be followed for 12 months
Secondary American Shoulder and Elbow Surgeons (ASES) ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best. Study participants will be followed for 12 months
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Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Recruiting NCT06120998 - Quality of Life After Arthroscopic Rotator Cuff Repair
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