Prosthesis versus exercise for rotator cuff tear arthropathy - protocol of a randomised controlled trial

Abstract

Introduction: Reverse total shoulder arthroplasty is a well-established treatment for patients with rotator cuff tear arthropathy. The outcome after reverse total shoulder arthroplasty has been investigated in several studies and national registries. However, the treatment has not been compared to non-surgical treatment. The primary aim of this trial is to investigate whether reverse total shoulder arthroplasty is superior to exercise in patients with rotator cuff tear arthropathy who are eligible for reverse total shoulder arthroplasty.

Methods: In this Nordic multicentre, randomised, controlled clinical trial, 102 patients with rotator cuff tear arthropathy who are eligible for reverse total shoulder arthroplasty will be allocated (1:1) to either reverse total shoulder arthroplasty followed by usual care or to an exercise intervention. The exercise intervention comprises 12 weeks of exercise with one weekly physiotherapist-supervised session and two home-based exercises. The primary outcome is the total Western Ontario Osteoarthritis of the Shoulder index score at a 12-month follow-up.

Conclusions: The ongoing randomised controlled trial will provide insights into treatment decisions for patients with rotator cuff tear arthropathy.

Funding: This study is funded by Aarhus University, the Health Research Foundation of the Central Denmark Region, the Danish Rheumatism Association, the Association of Danish Physiotherapists, the Health Foundation (Helsefonden), the Hartmann's Foundation and the Emil Hertz Foundation in Denmark.

Clinicaltrials: gov ID: NCT04864158.