International impact of large multi-centre surgical trials of arthroscopic subacromial decompression

Objectives To examine temporal trends in incidence of arthroscopic subacromial decompression (ASAD) surgery internationally during conduct and after publication of placebo controlled trials finding no evidence of meaningful benefit of ASAD for shoulder impingement. Design Observational study of incidence rates. Setting Large routinely collected datasets were used: outpatient data from Belgium and UK, and insurance claims and outpatient data from US. UK data were from Clinical Practice Research Datalink and Belgium and US data were from IQVIA. US and UK data spanned 2005 - 2019 and Belgium data 2011 - 2019. Participants Patients were eligible for inclusion in the study if they had at least one visit recorded in the database in a given year and cases were defined as patients undergoing ASAD for the first time in their records in a given year. Outcome measures We calculated incidence of ASAD over time, overall and stratified by age and sex. Characteristics of patients undergoing ASAD were also assessed over time. Results UK incidence has fallen since a peak of 4.7 per 10,000 person years in 2011 (when the CSAW trial began) to 1.8 in 2019. US incidence shows no clear pattern and remains consistently higher than the UK, at 11.5 per 100,000 person years in 2019. Changes in incidence patterns were similar across different age groups and sexes. The number of cases in Belgium was too small for meaningful conclusions. Conclusions We found ASAD rates have fallen in the UK during conduct and after publication of two large surgical RCTs from the UK and Finland that questioned the effectiveness of ASAD for shoulder impingement. A similar impact on clinical practice has not been seen in US. Further work to understand the barriers or concerns preventing international uptake of high quality evidence into clinical practice is needed.

Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up

Background Arthroscopic subacromial decompression is one of the most commonly performed shoulder surgeries in the world. It is performed to treat patients with suspected shoulder impingement syndrome, i.e., subacromial pain syndrome. Only few studies have specifically assessed return-to-work rates after subacromial decompression surgery. All existing evidence comes from open, unblinded study designs and this lack of blinding introduces the potential for bias. We assessed return to work and its predictors in patients with shoulder impingement syndrome in a secondary analysis of a placebo-surgery controlled trial. Methods One hundred eighty-four patients in a randomised trial had undergone arthroscopic subacromial decompression (n = 57), diagnostic arthroscopy, a placebo surgical intervention, (n = 59), or exercise therapy (n = 68). We assessed return to work, defined as having returned to work for at least two follow-up visits by the primary 24-month time point, work status at 24 and 60 months, and trajectories of return to work per follow-up time point. Patients and outcome assessors were blinded to the assignment regarding the arthroscopic subacromial decompression vs. diagnostic arthroscopy comparison. We assessed the treatment effect on the full analysis set as the difference between the groups in return-to-work rates and work status at 24 months and at 60 months using Chi-square test and the predictors of return to work with logistic regression analysis. Results There was no difference in the trajectories of return to work between the study groups. By 24 months, 50 of 57 patients (88%) had returned to work in the arthroscopic subacromial decompression group, while the respective figures were 52 of 59 (88%) in the diagnostic arthroscopy group and 61 of 68 (90%) in the exercise therapy group. No clinically relevant predictors of return to work were found. The proportion of patients at work was 80% (147/184) at 24 months and 73% (124/184) at 60 months, with no difference between the treatment groups (p-values 0.842 and 0.943, respectively). Conclusions Arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy or exercise therapy on return to work in patients with shoulder impingement syndrome. We did not find clinically relevant predictors of return to work either. Trial registration ClinicalTrials.gov identifier NCT00428870.

Should We be Routinely Performing Arthroscopic Subacromial Decompression During Rotator Cuff Repair (RCR)?

Symptomatic rotator cuff tears cause pain and impaired function. Arthroscopic rotator cuff repair is an established treatment when nonoperative management fails. However, debate exists regarding the requirement of concurrent subacromial decompression. This review aims to answer pertinent questions and outline relevant literature in the role of arthroscopic subacromial decompression in rotator cuff repair. Keywords: Decompression, Cuff, Arthroscopic, Repair.

The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study

Background Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment are common in clinical trials and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions: (i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure? (ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by supplementing written consent materials with a brief visual animation that outlines the details of the trial? And (iii) exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved? Methods This study aims to recruit 80 patients on the waiting list for ASD. Participants will be randomised (1:1) to either view a brief video animation explaining the hypothetical placebo-controlled trial in addition to written information or to written information only. Participants in both groups will be required to state if they would be willing to opt-in to the hypothetical ASD trial after immediately being presented with the consent material and again 1 week after completion of the consent process. Patients in both groups will also be required to complete a measure of trial literacy. Twenty participants will be purposively sampled to take part in an embedded qualitative study exploring understanding of trial concepts and factors contributing to willingness to opt-in. Discussion This feasibility study will provide evidence for optimising participant recruitment into a placebo-controlled trial of ASD by consenting patients using animated trial information in addition to written information. This pilot and feasibility data may also be relevant to placebo-controlled surgical trials more broadly, which are characterised by recruitment challenges. Trial registration ANZCTR, ACTRN12620001132932, date October 30, 2020

Morphology of the Undersurface of the Anterolateral Acromion and Its Relationship to Surrounding Structures

Background: A better understanding of the morphology underneath the acromion is needed to prevent complications after arthroscopic subacromial decompression. The precise correlations between the morphologic features underneath the acromion and the surrounding structures including the attachment of the coracoacromial ligament (CAL) and the origin of the deltoid middle head have not yet been determined in the absence of artifacts on the bony surface caused by dissection techniques. Moreover, anatomic findings in previous studies using only older-aged cadavers or dried bones may not reflect the morphologic features of younger and healthy specimens. Purpose: To characterize the anterolateral structures morphologically in the inferior aspect of the acromion, assess the relationships of these structures with surrounding structures without dissection artifacts on the bony surface, and verify the cadaveric data in the asymptomatic shoulders of living middle-aged patients. Study Design: Descriptive laboratory study. Methods: We initially analyzed the relationship between the morphology of the anterolateral structures and surrounding structures in 18 cadaveric shoulders (mean age, 81.8 years), 15 of which were subjected to macroscopic investigation of the CAL attachment and 3-dimensional micro—computed tomography investigation with radiopaque markers and 3 of which were subjected to histologic examination. We also analyzed the morphology underneath the anterolateral acromion in 24 asymptomatic shoulders of middle-aged patients (mean age, 54.8 years) to verify the cadaveric data. In both the cadaveric shoulders and the asymptomatic shoulders of live patients, the long axis, width, and height of the anterolateral prominence were measured by use of 3-dimensional CT imaging. Results: In cadavers, the anterolateral prominence underneath the acromion corresponded to the attachment of the CAL. Histologic evaluation revealed that the CAL was continuous to the deep layer of the deltoid middle head in the lateral acromion. The study in asymptomatic shoulders of middle-aged patients revealed bony prominences similar to those observed in cadavers. Conclusion: The anterolateral prominence, which corresponds to the attachment of the CAL below the acromion, may be a native structure below the acromion. Moreover, the CAL is continuous to the deep layer of the deltoid middle head in the lateral acromion.