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

Abstract

Importance: 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.

Trial registration: ClinicalTrials.gov identifier: NCT03295994.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Jain reported grants from the Vanderbilt Institute for Clinical and Translational Research during the conduct of the study. Dr Archer reported personal fees from the American Physical Therapy Association, Pacira, and Palladian Health outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Distributions of 12-Month Change in Shoulder Pain and Disability Index (SPADI) Scores by Treatment Group

Density is defined as relative frequency of SPADI scores.

Figure 2.. Power Curves for 3 Different Tests for Shoulder Pain and Disability Index

Power curves are shown for primary treatment comparison (solid lines) and interactions (dashed lines) from covariate adjusted complete case (navy lines), imputed case (orange lines), and unadjusted (cyan lines) models.