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Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial

dc.contributor.authorJain, Nitin B
dc.contributor.authorAyers, Gregory D.
dc.contributor.authorKoudelkova, Helen
dc.contributor.authorArcher, Kristin R.
dc.contributor.authorDickinson, Rebecca
dc.contributor.authorRichardson, Brian
dc.contributor.authorKuhn, John E.
dc.identifier.citationJain NB, Ayers GD, Koudelková H, et al. Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019;2(8):e199050. doi:10.1001/jamanetworkopen.2019.9050en_US
dc.descriptionOnly Vanderbilt University affiliated authors are listed on VUIR. For a full list of authors, access the version of record at
dc.description.abstractIMPORTANCE Rotator cuff disorders remain the most common cause of shoulder pain and are among the most common reasons for patients to seek care in primary and specialty settings. Although operative and nonoperative treatments are offered to patients with atraumatic rotator cuff tears, there is a lack of evidence to support operative vs nonoperative treatment. This paucity of evidence has been highlighted by several professional agencies and experts. OBJECTIVE To perform a pragmatic randomized clinical trial, the Arthroscopic Rotator Cuff trial, comparing pain and functional outcomes in patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears, and assessing heterogeneity of treatment effects by age and tear size. DESIGN, SETTING, AND PARTICIPANTS Trial protocol of the Arthroscopic Rotator Cuff trial. This pragmatic randomized clinical trial of an estimated 700 patients is adequately powered to accomplish its aims with 488 patients. Primary analysis will be conducted on an intent-to-treat population in the context of a mixed model. The multicenter trial started recruitment in 2018 with a 1-year follow-up duration. Patients aged 50 years or older to younger than 85 years with magnetic resonance imaging-confirmed atraumatic rotator cuff tears that are suitable for either operative or nonoperative treatment will be enrolled. Block randomization will be performed and stratified by site, age, and tear size. INTERVENTION Nonoperative treatment consists of an approximately 3-month standardized physical therapy program, whereas operative treatment consists of rotator cuff surgery followed by approximately 4 months of postoperative rehabilitation. MAIN OUTCOMES AND MEASURES The primary outcome is patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score measured at 1 year of follow-up. DISCUSSION The Arthroscopic Rotator Cuff trial is ongoing, and 12 sites with more than 40 physicians are currently recruiting patients. Although there is variation by site, as of May 2, 2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited. Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.en_US
dc.description.sponsorshipFunding/Support: Research reported in this article was partially funded through award 1605-35413 from the Patient-Centered Outcomes Research Institute, award U34AR069201 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, and Clinical and Translational Science Award UL1TR000445 from the National Center for Advancing Translational Sciences. Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.en_US
dc.publisherJAMA Networks Openen_US
dc.rightsOpen Access: This is an open access article distributed under the terms of the CC-BY License. © 2019 Jain NB et al. JAMA Network Open.
dc.titleOperative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trialen_US

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