Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis (in adults 60 years and over): Differences between Interventions (RAPSODI-AUS)
RAPSODI-AUS Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI): a multi-centre, pragmatic, parallel group, superiority randomised controlled trial; examining Reverse vs conventional (anatomic) shoulder replacement for adults 60 years and over with shoulder osteoarthritis
Deakin University
430 participants
Apr 30, 2023
Interventional
Conditions
Summary
RAPSODI-AUS aims to find the best type of joint replacement for the treatment of painful OA of the shoulder by investigating if reverse Total Shoulder Replacement is better than anatomical Total Shoulder Replacement at improving shoulder pain and function. This is a sister trial with the United Kingdom - RAPSODI-UK - following similar protocols. The study will recruit a total of 430 participants across all participating sites and surgeons in Australia, 215 patients will be randomised to each surgery type. At the end of the study we aim to provide clinical evidence to assist surgeons and their patients to choose the most appropriate replacement procedure to treat their Painful Osteoarthritis of the Shoulder.
Eligibility
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Interventions
In shoulder replacement surgery, Orthopaedic Surgeons remove the damaged parts of the shoulder joint (natural bone) and replace them with plastic or metal parts. For Reverse Total Shoulder Replacement (rTSR) procedures, the arrangement of the ball and socket components are reversed, the metal ball is attached to the inside of the shoulder blade (instead of the humeral stem), making use of the deltoid muscle for movement of the arm. It does not rely on an intact or functioning rotator cuff. This type of surgery is used routinely in Australia and is anticipated to take two to three hours. The surgery will be conducted by skilled Upper-Limb Orthopaedic surgeons and they will be Investigators in the RAPSODI-AUS trial. Patients will be screened by the surgeon and site coordinator to ensure eligibility for the trial, specifically for 60 years of age and over with painful osteoarthritis (OA) of the shoulder joint with an intact rotator cuff and bone stock suitable for shoulder arthroplasty. Eligible patients will be provided with a Patient Information Sheet, surgeon will discuss the trial and obtain informed consent. They will be registered in the online Australian Orthopaedics Association National Joint Replacement Registry (AOANJRR) portal. Details of the implants and techniques used will be recorded in the routinely collected AOANJRR data form, obtained during the procedure. There will also be a number of other Surgeon/Site case report forms (CRFs) and these processes will be monitored for completeness and compliance by the AOANJRR Clinical Studies team for the duration of the study. Patients will also provide responses to questionnaires via an online portal - these will be collected preoperatively, and at 3, 6, 12, 18 and 24 months. They will be invited to complete the surveys via sms text or email, with telephone calls as a back up to assist patients who may need help. There will be an embedded Qualitative substudy of approximately 20 selected patients, participating in semi-structured interviews at 2 months and 12 months. (40 interviews in total). These participants will have indicated willingness to participate at initial consent. Using purposive sampling of 10 from each arm of the study - aTSR and rTSR - and variation in age and geographical location, from a minimum of 4 study sites. This will be to gain a range of perspectives and a rich understanding of participants' experiences and perceptions. Additional participants may be recruited at 12 months, using trial pain/function data to inform selection.
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ACTRN12622001364763