Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)
|ClinicalTrials.gov Identifier: NCT03295994|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: Operative Procedure: Non-Operative||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Active Comparator: Operative
surgery + post-operative physical therapy
Arthroscopic rotator cuff surgery followed by physical therapy.
Active Comparator: Non-Operative
non-operative physical therapy
Physical therapy (without surgery).
- Shoulder Pain & Disability Index (SPADI) [ Time Frame: Study participants will be followed for 12 months ]SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
- American Shoulder and Elbow Surgeons (ASES) [ Time Frame: Study participants will be followed for 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295994
|Principal Investigator:||Nitin Jain, MD,MSPH||Vanderbilt University Medical Center|