Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)
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|ClinicalTrials.gov Identifier: NCT03295994|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : May 26, 2021
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295994
|Principal Investigator:||Nitin Jain, MD,MSPH||Vanderbilt University Medical Center|