Journal Article

Subacromial balloon spacer for irreparable rotator cuff tears

Chokotho, Linda, Beard, David

2022

Overview

REACTS trial2 serves three important purposes: first, it provides rigorous evidence for the efficacy of a potentially new treatment for patients with a rotator cuff tear; second, it demonstrates a new adaptive design, which might prove useful for future surgical trials; third, it highlights the development of scientific evaluation in surgery and device assessment. By contrast, much surgical device uptake is often rapid with minimal governance; the result has been a trail of poorly evaluated, flawed, and failed devices and procedures, which sadly have had negative effects on patients.4–6 Surgical evaluation, in terms of optimum sequencing, has lagged behind the tightly controlled pharmaceutical industry for too long. Dr P Marazzi/Science Photo Library This trial is a good example of how well surgical research has changed and responded to the disparaging, but ultimately catalytic and helpful, words of The Lancet's Editor-in-Chief Richard Horton, who, in 1996, called for major improvements in the quality of clinical trials in surgery.7 Driven by Derek Alderson, Dion Morton, Peter Hutchinson, and colleagues at the Royal College of Surgeons of England, and the inception of dedicated surgical trials units in the UK and globally during the past 15 years, surgical science is almost unrecognisable from the past.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Clinical trials / Debridement / Design / Evaluation / Humans / Injuries / Innovations / Orthopedics / Patients / Pharmaceutical industry / Range of Motion, Articular / Rotator cuff / Rotator Cuff Injuries - surgery / Surgery / Surgical apparatus & instruments / Treatment Outcome