Arc Trial2022-05-17T12:46:28-06:00

PURPOSE OF THIS STUDY

The ARC study is a randomized clinical trial comparing operative and non-operative treatment for rotator cuff tears that develop over time. This study aims to find out which treatment works better and for whom, in order to help patients in the future select the best treatment for them.

Rotator cuff tears are one of the most common causes of shoulder pain in adults in the United States, accounting for 10.7 million outpatient doctor visits in 2013. Specifically, it is estimated that 65-70% of adults with shoulder pain have an underlying rotator cuff disorder. Rotator cuff injuries are common due to their degenerative nature, meaning that they occur slowly over time as a person ages, often without a distinct injury. These kinds of tears are classified as atraumatic.

The two standard treatments for atraumatic rotator cuff tears are non-operative (physical therapy alone) and operative (surgery followed by physical therapy). The percentage of rotator cuff patients treated with surgery rose from 33.8% to 40.4% from 2005 to 2012, showing an increasing tendency to treat with surgery. It is not clear, however, if this trend has resulted in more successful outcomes for patients. The purpose of the ARC Trial is to help answer this question. We are also studying whether size of tear and age influence which treatment works best. This trial is different from previous observational studies because patients are randomly assigned to a treatment group, which will allow us to better measure the differences between these two treatments without any biases. We believe this study will help patients and providers to make better and more informed decisions in the future.

Study Updates

Recruiting for the study began at Vanderbilt in January of 2018, with 11 more sites brought on board by June 2018 and 4 more at the end of 2019/ beginning of 2020, bringing us to a total of 16 sites currently recruiting. There are two more sites preparing to join the study when recruiting resumes after the COVID-19 pandemic. A couple exciting things that have happened since then; the ARC Trial Protocol was published by the JAMA Network (see our publications page for more information), and we have surpassed 10,000 patients screened and 100 patients enrolled.

Here’s the update as of March 19th, 2020:

  • 120 patients have been enrolled in the study and randomized to a treatment
    • 60 (50%) randomized to operative treatment (surgery), 60 (50%) randomized to non-operative treatment (physical therapy)
    • 57 % female, 43% male
    • 80% White, 12% Black/ African American, 4% Missing data, 1% Asian, 1% American Native
  • Patients who have reached follow-up time points
    • 3 months = 105
    • 6 months = 96
    • 12 months = 66
    • 92% of sent questionnaires are successfully filled out and returned
  • Tear size representation:
    • 69% Less than 2cm
    • 31% Greater than or equal to 2cm
  • Age representation:
    • 55 % less than 65 years old
    • 45% greater than or equal to 65 years old

INTERESTED IN PARTICIPATING?

  • People 40-84 with rotator cuff tears ages who meet all eligibility criteria may participate in this study.
  • You will need to see an ARC shoulder study specialist who can diagnose your shoulder pain and evaluate your eligibility for the study.

FIND A SITE NEAR YOU!

Please click on the site name below or its location on the map for more information!

PATIENT FREQUENTLY ASKED QUESTIONS

Will I be withdrawn from the study if I do not have my assigned treatment?2019-07-17T09:36:29-06:00

No, we will continue to follow you as planned even if you switch treatment groups or do not pursue treatment at all.