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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.

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.

SUBMITTER: Jain NB

PROVIDER: S-EPMC6692688 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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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.

Jain Nitin B NB Ayers Gregory D GD Koudelková Helen H Archer Kristin R KR Dickinson Rebecca R Richardson Brian B Derryberry Marian M Kuhn John E JE

JAMA network open 20190802 8

<h4>Importance</h4>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.<h4>Objective</h4>To perform a pragmati ...[more]

PMID: 31397866

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Project description:PurposeTo determine whether anterior cable tears could be identified at the time of arthroscopic rotator cuff repair and determine the characteristics of the anterior cable tears identified.MethodsFrom 2016 to 2017 all shoulder arthroscopies had data collected prospectively at the time of surgery, specifically including injury to the capsular and tendon zones of insertion on the greater tuberosity. Anterior cable position and degree of injury and medialization were recorded, as well as complete findings of the diagnostic arthroscopy. The inclusion criterion was primary shoulder arthroscopy. The exclusion criterion was any revision shoulder arthroscopy. All arthroscopic rotator cuff repairs (ARCR) were grouped together and all other nonarthroscopic rotator cuff repair surgeries (non-ARCR) were grouped together.ResultsIn total, 118 shoulder arthroscopies had data collected prospectively at the time of surgery: 90 primary shoulder arthroscopies met the inclusion criteria; 28 were excluded because they were revision surgeries. There were 42 patients in the ARCR group (Group 1). Six of these were partial tears, and 36 were full-thickness tears. There were 48 patients in the non-ARCR group (Group 2). The non-ARCR Group 2 served as an anatomic baseline for ARCR Group 1. In all 90 shoulders, the rotator cable and anterior cable were identified. Group 1 (ARCR) incidence of anterior cable tears with abnormal position was 71.4% compared to 2.1% in group 2 (non-ARCR) (P < .001) Group 1 (ARCR) incidence of anterior cable tears with normal anterior cable position (n = 12) was compared to abnormal anterior cable position (n = 30). Injury to the anterior footprint capsular and tendon zones were compared. Normal anterior cable position correlated with no or low-grade injury to anterior footprint capsular zone. (Nimura zone C1). Abnormal anterior cable displacement graded as moderate (n = 20) and severe (n = 10) were compared for injury to the anterior footprint. Moderate displacement correlated with complete or high grade injury to C1 in 85% and complete injury to R1 in 45% (P < .001 and .049). In severe displacement complete C1 injury was 100%, and complete R1 injury was 100% (P < .001 and .001).ConclusionsAnterior cable tears are universally identified in ARCR. Three patterns of medial displacement severity correlated with injury to a crucial insertion zone (C1) at the anterior footprint. The degree of anterior cable disruption at the anterior footprint and displacement was commonly disproportionately greater than the injury to the supraspinatus.Level of evidenceLevel III, diagnostic study.

Project description:BackgroundThe evidence to support operative versus nonoperative treatment for rotator cuff tears is sparse and inconclusive.PurposeTo assess pain and functional outcomes in patients undergoing operative and nonoperative treatments for rotator cuff tears.Study designCohort study; Level of evidence, 3.MethodsFrom March 2011 to February 2015, a multicenter cohort of patients with rotator cuff tears undergoing operative and nonoperative treatments was recruited. Patients completed a detailed history questionnaire, the Shoulder Pain and Disability Index (SPADI), and the American Shoulder and Elbow Surgeons (ASES) standardized form and underwent magnetic resonance imaging. In addition to baseline assessments, patients received follow-up questionnaires at 3, 6, 12, and 18 months. Propensity score weighting was used to balance differences in characteristics of the operative and nonoperative groups.ResultsAdjusted for propensity scores, the operative (n = 50) and nonoperative (n = 77) groups had similar characteristics, as evidenced by the small standardized mean differences between the groups. Adjusted mean differences in the SPADI and ASES scores between the operative and nonoperative groups were -22.0 points (95% CI, -32.1 to -11.8) and -22.2 points (95% CI, -32.8 to -11.6) at 18 months, respectively. The operative group had a significantly higher proportion of patients who showed ≥30% (P = .002) and ≥50% (P < .0001) improvement in SPADI and ASES scores as compared with the nonoperative group.ConclusionIn this prospective cohort study, patients undergoing operative treatment had significantly better pain and functional outcomes as compared with patients undergoing nonoperative treatment for rotator cuff tears. Differences between the 2 groups in SPADI and ASES scores at the 6- to 18-month time points met the minimal clinically important difference (depending on the threshold used). A large randomized controlled trial is needed to answer this question more definitively.

Dataset Information

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

Publications

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

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