Title: Reverse or Anatomical (replacement) for Painful Shoulder Osteoarthritis: Differences between Interventions._x000D_ Acronym; RAPSODI
Funder: Department of Health and Social Care

Abstract: Aim- To find the best type of joint replacement for the treatment of painful osteoarthritis of the shoulder._x000D_ Background- With increasing age, shoulder osteoarthritis is common and causes severe pain and stiffness making everyday activities difficult. A shoulder replacement is an effective solution, reducing pain and allowing the shoulder to move better. The operation replaces damaged bone with new metal and plastic parts. There are two types of shoulder replacement; _x000D_ 1.Anatomic Total Shoulder Replacement which relies on the tendons (Rotator Cuff) around the shoulder to be intact and healthy. _x000D_ 2.Reverse Total Shoulder Replacement, which is usually used when the rotator cuff becomes weaker or torn._x000D_ The rotator cuff can weaken with age which may cause an anatomic replacement to stop working. This could mean a further operation to change the shoulder to a reverse total shoulder replacement. For this reason, an increasing number of patients are offered reverse shoulder replacements even when their rotator cuff is intact. Currently, there is no scientific evidence to support this change and no guidance to recommend which is the best type of shoulder joint replacement. _x000D_ Study Design- People over the age of 60 who would benefit from a shoulder replacement and have an attached working rotator cuff will be asked to take part in the study. Before their operation they will fill in questionnaires about pain and function. The type of replacement given will be decided by a process called randomisation. This means that the patient may be allocated to have either an anatomic or reverse total shoulder replacement with equal chance of either type of replacement. Participants will not know which treatment group they are in until the end of the study. Clinic visits after the operation will happen as normal but with the addition of remote questionnaires at 3, 6, 12, 18 and 24 months. A subgroup of about 20 participants will be interviewed at 2 and 12 months after their operations to share experiences and thoughts about their recovery. We will investigate which type of surgery gives value for money and the best outcome. _x000D_ Patient and Public Involvement (PPI)- The local PPI Group played a central role in designing this study. They felt that this is an important question to answer, and that with surgery it is vital to get ‘it’ right first time both for the patient and for economic reasons. We therefore asked 34 surgeons in a survey about their practice and found 87% already perform or would consider a reverse shoulder in patients with an intact rotator cuff and 74% would be willing to change practice based on the results of study evidence. Fourteen people who are volunteers for the hospital completed a survey containing a study information sheet. Thirteen said that they would consider being randomised to a study of this type. The PPI group influenced the choice of outcome measure and suggested the addition of a linked qualitative study. A member of the group has agreed to be a co-applicant for the study. All participant documentation will be written with input from the PPI group, strengthened with support from diversity and inclusion experts. _x000D_ Dissemination- We will share study results through clinical networks, at national and international conferences, and publish in high quality journals. We will also make certain that information is available to future patients through a variety of accessible sources.

Lay abstract: Background_x000D_ Currently patients who have painful osteoarthritis of the shoulder joint and have an intact rotator cuff, having exhausted conservative treatments, are offered a shoulder replacement. Usually an anatomical replacement (aTSR) is done. It closely mirrors the normal anatomy and needs intact tendons around the shoulder (rotator cuff) to allow the patient to lift the arm above shoulder height. The most common reason for revision of aTSR is rotator cuff failure. Increasingly in patients aged > 60 years surgeons are using a reverse total shoulder replacement (rTSR), which can be used in patients with rotator cuff failure. Surgeons believe that patients recover more quickly, outcomes are more consistent and there is lower risk of revision. To date there are no randomised controlled trials (RCT) comparing the two types of implant in this patient group. A Cochrane review (2020) reported a lack of high-quality studies and it is uncertain whether rTSR has better outcomes than aTSR._x000D_ _x000D_ Aims and objectives_x000D_ The trial aims to investigate whether rTSR is superior to aTSR for the treatment of painful osteoarthritis of the glenohumeral joint with an intact rotator cuff in patients over the age of sixty years as measured by patient rated pain and function using the Shoulder Pain and Disability Index (SPADI) at 24 months adjusted for baseline SPADI score, and whether this is a cost-effective treatment option. _x000D_ _x000D_ Additional objectives are analysis of secondary outcomes including the Oxford Shoulder Score, rate of recovery of pain and function, adverse events and EQ-5D-5L to estimate cost-effectiveness, and a qualitative exploration of patients’ experiences, goals, and perceptions of acceptability of shoulder arthroplasty and recovery over time. We will report the rate of revision and mortality._x000D_ _x000D_ Methods_x000D_ The trial is a pragmatic multi-centre two-parallel group superiority RCT with masking of patients and assessors. It includes an eight-month internal pilot together with a full health economic analysis and a nested qualitative interview study. The research will be undertaken in NHS shoulder arthroplasty units in England and Wales. Patients will be screened for eligibility (suitable for shoulder arthroplasty and intact rotator cuff) and invited for recruitment prior to surgery. We need data from 364 participants at 24 months to provide 90% statistical power to establish the superiority of rTSR over aTSR, determined by a greater than 8 points SPADI difference between the two implants._x000D_ _x000D_ Timelines for delivery_x000D_ The study will be of 62 months duration: 6 months set up, 8 months internal pilot; 16 months main trial recruitment; 24 months follow up; 8 months data cleaning, checking, analysis and reporting._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ This trial will improve decision making about which type of shoulder replacement to offer patients aged 60 years and over with osteoarthritis and an intact rotator cuff._x000D_ Targets for dissemination will include NICE, Clinical Commissioning Groups, Department of Health and Social Care and the Specialty Advisory Committee (for the curriculum for clinicians who do these procedures). Results will be presented at professional meetings and published in high impact journals. A summary of results will be developed in plain English for patient focused outlet.

Research activity codes: 6.4 SURGERY
Health categories: MUSCULOSKELETAL