RecruitingACTRN12622001364763

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


Sponsor

Deakin University

Enrollment

430 participants

Start Date

Apr 30, 2023

Study Type

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

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study, called RAPSODI-AUS, is looking at the best way to replace a shoulder joint that has been worn down by osteoarthritis — the kind of joint damage where the smooth cartilage covering the bones gradually breaks down, causing pain and stiffness. There are two main types of shoulder replacement surgery available: an "anatomical" replacement that closely mirrors the natural shoulder structure, and a "reverse" replacement where the ball-and-socket is flipped, which can work better for some types of shoulder damage. Surgeons have debated for years which approach gives better outcomes, and this trial aims to settle that question with solid evidence. The trial will recruit 430 adults aged 60 and over across Australian hospital sites, with half receiving each type of surgery. Participants will be followed over time to measure pain, shoulder function, and quality of life. Australia is running this study in parallel with a similar UK trial (RAPSODI-UK) to build an even stronger evidence base. You may be eligible if you are 60 or older, have been diagnosed with shoulder osteoarthritis that has not responded to other treatments, have an intact rotator cuff (confirmed by imaging), and do not have inflammatory arthritis or a recent shoulder injury. If both your shoulders need replacing, you cannot participate if you have already been enrolled for the other shoulder.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(25)

St John of God Hospital, Geelong - Geelong

NSW,QLD,TAS,WA,VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

NSW,QLD,TAS,WA,VIC, Australia

Wagga Wagga Base Hospital - Wagga Wagga

NSW,QLD,TAS,WA,VIC, Australia

Gold Coast University Hospital - Southport

NSW,QLD,TAS,WA,VIC, Australia

Robina Hospital - Robina

NSW,QLD,TAS,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,TAS,WA,VIC, Australia

The Prince Charles Hospital - Chermside

NSW,QLD,TAS,WA,VIC, Australia

Surgical Treatment and Rehabilitation Service (STARS) - Herston

NSW,QLD,TAS,WA,VIC, Australia

Redcliffe Hospital - Redcliffe

NSW,QLD,TAS,WA,VIC, Australia

Calvary Health Care Tasmania - Hobart - Lenah Valley

NSW,QLD,TAS,WA,VIC, Australia

Coffs Harbour Base Hospital - Coffs Harbour

NSW,QLD,TAS,WA,VIC, Australia

Baringa Private Hospital - Coffs Harbour

NSW,QLD,TAS,WA,VIC, Australia

Sunshine Coast University Private Hospital - Birtinya

NSW,QLD,TAS,WA,VIC, Australia

Sunshine Coast University Hospital - Birtinya

NSW,QLD,TAS,WA,VIC, Australia

Nambour General Hospital - Nambour

NSW,QLD,TAS,WA,VIC, Australia

St John of God Hospital, Murdoch - Murdoch

NSW,QLD,TAS,WA,VIC, Australia

Calvary Private Hospital - Wagga Wagga

NSW,QLD,TAS,WA,VIC, Australia

Eastern Health - Box Hill

NSW,QLD,TAS,WA,VIC, Australia

Maroondah Hospital - Ringwood East

NSW,QLD,TAS,WA,VIC, Australia

Frankston Hospital - Frankston

NSW,QLD,TAS,WA,VIC, Australia

St George Hospital - Kogarah

NSW,QLD,TAS,WA,VIC, Australia

The Sutherland Hospital - Caringbah

NSW,QLD,TAS,WA,VIC, Australia

Footscray Hospital - Footscray

NSW,QLD,TAS,WA,VIC, Australia

Williamstown Hospital - Williamstown

NSW,QLD,TAS,WA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

NSW,QLD,TAS,WA,VIC, Australia

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ACTRN12622001364763