Non-inferiority and cost-effectiveness trial of isolated biceps tenotomy versus tenotomy with rotator cuff repair in patients with stage 2-3 Goutallier fatty degenerative cuff lesions (TenCuRe study): protocol of a multicentre randomised controlled trial.

Introduction: For patients who are diagnosed with lesions of the rotator cuff that present advanced levels of fatty degeneration, arthroscopic repair of the rotator cuff remains controversial. This controversy can be attributed to the frequently reported high failure rate of the tendon fixation and the fact that it remains unclear why repair for these tears results in significant clinical improvement independent of the occurrence of such a re-tear. Recent publications have reported comparable clinical improvements when merely a tenotomy of the long head of the biceps tendon was performed and the rotator cuff tear was left untreated. These observations raise questions on the value of performing the more extensive cuff repairs in degenerative cuff tears. Even more, rehabilitation after an isolated tenotomy is much less cumbersome as compared with rehabilitation after rotator cuff repair and, therefore, might result in improved patient satisfaction. The goal of this trial is to study function and quality-of-life of patients undergoing arthroscopic biceps tenotomy with or without an additional cuff repair and to include an economic evaluation.
Methods and Analysis: This multicentre randomised controlled non-inferiority trial, including an economic evaluation, is designed to compare the short-term and long-term outcome of patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair. We will include 172 patients with stage 2-3 Goutallier fatty infiltration cuff tears and with clinical symptoms of biceps pathology. Primary outcome is the rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index) on the short term (6 months postoperatively). Secondary outcomes are quality-of-life 1, 2 and 5 year postoperatively and function (Constant-Murley score, glenohumeral range of motion), recovery status, pain (visual analogue scale), economic evaluation, satisfaction of treatment on the short-term and long-term and re-tear rate at 6 months determined with an ultrasound.
Ethics and Dissemination: This trial has been approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands (NL54313.100.15) and will be performed in accordance with the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results of this study will be reported in peer-reviewed journals and at (inter)national conferences. Furthermore, we will share our findings with the appropriate guideline committees.
Trial Registration Number: The Dutch Trial Registry (NL4010).
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)