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Introduction
Background and rationale {6a}
Rotator cuff pathology is common and increases with age, affecting many people over the age of 45 years and most people over the age of 60, with more than half having shoulder pain [1, 2]. Shoulder pain is common (22% prevalence in adults) and makes up approximately 1% of all primary care presentations, 85% of which will have rotator cuff pathology [3, 4, 5–6]. Large acute tears may occur as a result of significant trauma (such as a shoulder dislocation) but most tears are not acute.
The two most common surgical procedures for patients with shoulder pain are subacromial decompression and rotator cuff repair (suturing and anchoring the torn tendon to the humeral head insertion), either separately or in combination.
Subacromial decompression is performed arthroscopically and involves removal of bursal tissue and the bony under-surface of the acromion to decompress the passage of the rotator cuff tendons through the subacromial space. The effectiveness of subacromial decompression as stand-alone treatment for rotator cuff disease (excluding full thickness tears) has been called into question based upon high-certainty evidence that it provides no clinically important benefits over placebo in pain or function [7, 8–9] with a BMJ guideline panel making a strong recommendation against use of this surgery for shoulder pain [10].
The Australian Rotator Cuff (ARC) study investigates the effectiveness of a strategy to surgically repair full thickness, non-acute tears. Such lesions make up over 75% of all tears [11] and are often treated with surgery following failed non-operative management. Rotator cuff repair is the most common surgical procedure performed in the shoulder, with rates increasing [12, 13, 14, 15, 16–17]. The rationale for surgical repair is to improve symptoms (pain and function) which are believed to arise from the tear and to prevent the tear from becoming larger.
In contrast to subacromial decompression, results from a randomised placebo-controlled trial of rotator cuff repair have not been reported. A 2019 Cochrane review that included nine randomised trials involving 1007 participants comparing rotator cuff repair with or without decompression to other (non-surgical) active interventions noted that all trials were at high risk of bias, most notably for selection and performance bias due to failure to blind both participants and study personnel to treatment...