NCT03295994

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 40 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic Rotator Cuff Surgery	Arthroscopic rotator cuff surgery
PROCEDURE	Physical Therapy	Physical therapy

Timeline

• Start date: 2018-03-19
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2017-09-28
• Last updated: 2026-03-30

Locations

19 sites across 1 country: United States