Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair

Abstract

Introduction Rotator cuff tear is a very common and disabling condition that can be related to acute trauma. Rotator cuff tear surgery is a well-established form of treatment in acute rotator cuff tears. Despite its widespread use and almost a gold standard position, the efficacy of an arthroscopic rotator cuff repair is still unknown. The objective of this trial is to investigate the difference in outcome between arthroscopic rotator cuff repair and inspection of the shoulder joint defined as placebo surgery in patients 45-70 years of age with an acute rotator tear related to trauma.Methods and analysis Acute Cuff Tear Repair Trial (ACCURATE) is a randomised, placebo-controlled, multicentre efficacy trial with sample size of 180 patients. Concealed allocation is done in 1: 1 ratio. The randomisation is stratified according to participating hospital, gender and baseline Western Ontario Rotator Cuff Index (WORC). Both groups receive the same standardised postoperative treatment and physiotherapy. The primary outcome measure is the change in WORC score from baseline to 2-year follow-up. Secondary outcome measures include Constant-Murley Score, the Numerical Rating Scale for pain, subjective patient satisfaction and the health-related quality of life instrument 15 dimensions (15D). Patients and outcome assessors are blinded from the allocated intervention. The primary analysis of results will be conducted according to intention-to-treat analysis.Ethics and dissemination The study protocol for this clinical trial has been approved by the Ethics Committee of the Hospital District of Southwest Finland and Regional Ethics Committee in Linkoping Sweden and Regional Committees for Medical and Health Research Ethics South East in Norway. Every recruiting centre will apply local research approvals. The results of this study will be submitted for publication in peer-reviewed journals.