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Comparative Effectiveness of Operative Versus Nonoperative Treatment for Rotator Cuff Tears: A Propensity Score Analysis From the ROW Cohort.

ABSTRACT: BACKGROUND:The evidence to support operative versus nonoperative treatment for rotator cuff tears is sparse and inconclusive. PURPOSE:To assess pain and functional outcomes in patients undergoing operative and nonoperative treatments for rotator cuff tears. STUDY DESIGN:Cohort study; Level of evidence, 3. METHODS:From 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. RESULTS:Adjusted 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. CONCLUSION:In 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.

SUBMITTER: Jain NB

PROVIDER: S-EPMC7325686 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Comparative Effectiveness of Operative Versus Nonoperative Treatment for Rotator Cuff Tears: A Propensity Score Analysis From the ROW Cohort.

Jain Nitin B NB Ayers Gregory D GD Fan Run R Kuhn John E JE Warner Jon J P JJP Baumgarten Keith M KM Matzkin Elizabeth E Higgins Laurence D LD

The American journal of sports medicine 20190913 13

<h4>Background</h4>The evidence to support operative versus nonoperative treatment for rotator cuff tears is sparse and inconclusive.<h4>Purpose</h4>To assess pain and functional outcomes in patients undergoing operative and nonoperative treatments for rotator cuff tears.<h4>Study design</h4>Cohort study; Level of evidence, 3.<h4>Methods</h4>From March 2011 to February 2015, a multicenter cohort of patients with rotator cuff tears undergoing operative and nonoperative treatments was recruited. P ...[more]

PMID: 31518155

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Project description: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.

Project description:BACKGROUND: The single-row and double-row fixation techniques have been widely used for rotator cuff tears. However, whether the double-row technique produces superior clinical or anatomic outcomes is still considered controversial. This study aims to use meta-analysis to compare the clinical and anatomical outcomes between the two techniques. METHODS: The Pubmed, Embase, and Cochrane library databases were searched for relevant studies published before November 1, 2012. Studies clearly reporting a comparison of the single-row and double-row techniques were selected. The Constant, ASES, and UCLA scale systems and the rotator cuff integrity rate were evaluated. The weighted mean differences and relative risks were calculated using a fixed-effects or random-effects model. RESULTS: Eight studies were included in this meta-analysis. The weighted mean differences of the ASES (-0.84; P?=?0.04; I(2)?=?0%) and UCLA (-0.75; P?=?0.007; I(2)?=?0%) scales were significantly low in the single-row group for full-thickness rotator cuff tears. For tear sizes smaller than 3 cm, no significant difference was found between the groups no matter in Constant (P?=?0.95; I(2)?=?0%), ASES (P?=?0.77; I(2)?=?0%), or UCLA (P?=?0.24; I(2)?=?13%) scales. For tear sizes larger than 3 cm, the ASES (-1.95; P?=?0.001; I(2)?=?49%) and UCLA (-1.17; P?=?0.006; I(2)?=?0%) scales were markedly lower in the single-row group. The integrity of the rotator cuff (0.81; P?=?0.0004; I(2)?=?10%) was greater and the partial thickness retear rate (1.93; P?=?0.007; I(2)?=?10%) was less in the double-row group. Full-thickness retears showed no difference between the groups (P?=?0.15; I(2)?=?0%). CONCLUSION: The meta-analysis suggests that the double-row fixation technique increases post-operative rotator cuff integrity and improves the clinical outcomes, especially for full-thickness rotator cuff tears larger than 3 cm. For tear sizes smaller than 3 cm, there was no difference in the clinical outcomes between the two techniques. LEVEL OF EVIDENCE: Level I.

Dataset Information

Comparative Effectiveness of Operative Versus Nonoperative Treatment for Rotator Cuff Tears: A Propensity Score Analysis From the ROW Cohort.

Publications

Comparative Effectiveness of Operative Versus Nonoperative Treatment for Rotator Cuff Tears: A Propensity Score Analysis From the ROW Cohort.

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