Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI-UK)

Plain English Summary

Background and study aims
The aim of this study is to find the best type of joint replacement for the treatment of painful osteoarthritis of the shoulder.

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:
1. Anatomic Total Shoulder Replacement which relies on the tendons (Rotator Cuff) around the shoulder to be intact and healthy
2. Reverse Total Shoulder Replacement, which is usually used when the rotator cuff becomes weaker or torn

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. We will investigate which type of surgery gives value for money and the best outcome.

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 the 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 the 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.

Who can participate?
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.

What does the study involve?
Before their operation, participants will fill in questionnaires about pain and function. At the time of surgery, 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 (like tossing a coin). 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.

What are the possible benefits and risks of participating?
Shoulder replacements can only be improved with the help of patients. So taking part in this study means that patients may help improve the care of future patients who need shoulder replacements. Patients may also have more support taking part in the study because of the wider team involved. There is no increased risk for patients taking part in the study. The NHS has treated patients with the types of shoulder replacements being compared in this study for many years. Patients taking part will face the same risks of surgery and receive the same care as patients who have one of these shoulder replacements without taking part in the study. Any adverse events that patients taking part may experience will be followed-up according to regulatory requirements.

Where is the study run from?
Wrightington, Wigan, and Leigh Teaching Hospitals NHS Foundation Trust (UK) in collaboration with York Trials Unit (UK)

When is the study starting and how long is it expected to run for?
From March 2022 to April 2027

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) (UK)

Who is the main contact?
The study team can be contacted at ytu-rapsodi@york.ac.uk

Study website

Contact information

Prof Ian Trail
Principal Investigator

Wrightington, Wigan & Leigh NHS Foundation Trust
Hall Lane
Appley Bridge
Wigan
WN6 0XT
United Kingdom

ORCID ID	0000-0003-1874-019X
Phone	+44 (0)1257 488213
Email	Ian.Trail@wwl.nhs.uk

Prof Joseph Dias
Principal Investigator

Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

ORCID ID	0000-0001-5360-4543
Phone	+44 (0)116 258 4702
Email	joseph.dias@uhl-tr.nhs.uk

Dr Stephen Brealey
Public, Scientific

Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom

ORCID ID	0000-0001-9749-7014
Phone	+44 (0)7450027363
Email	stephen.brealey@york.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Wrightington, Wigan and Leigh NHS Foundation Trust
Hospital/treatment centre

Hall Lane
Appley Bridge
Wigan
WN6 0XT
England
United Kingdom

Phone	+44 (0)1257 488213
Email	Helen.Spickett@wwl.nhs.uk
Website	http://www.wwl.nhs.uk/
"ROR"	https://ror.org/028mrxf52

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

11/04/2025: Contact details updated.
29/08/2024: Protocol added.
27/08/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2024 to 30/04/2026.
2. The following study participating centres were added: Airedale General Hospital, Musgrave Park Hospital, Belfast, Royal Berkshire Hospital Foundation Trust, Sandwell and West Birmingham Hospital, Southmead Hospital, Bristol
West Suffolk Hospital, University Hospital of Wales, St James' University Hospital, The Countess of Chester Hospital NHS FT
Chesterfield Royal Hospital, Colchester Hospital, University Hospital Coventry, Royal Derby Hospital, Prince Phillip Hospital (Wales), Ipswich Hospital, Leicester Royal Infirmary, Broadgreen Hospital Liverpool, Trafford General Hospital, Milton Keynes University Hospital, Furness General Hospital, Morecambe Bay, Musgrove Park Hospital, Somerset, Norfolk and Norwich University Hospital, North Tyneside General Hospital, Northumbria, City Hospital, Nottingham, Nuffield Orthopaedic Centre, Oxford, Peterborough City Hospital, Northern General Hospital Sheffield, Royal National Orthopaedic Hospital, Princess Royal Hospital (West Sussex), Wrightington Hospital, Yeovil District Hospital.
18/12/2023: Individual participant data (IPD) sharing plan and summary added.
11/11/2022: The following changes have been updated in the trial record:
1. The recruitment start date has been changed from 01/09/2022 to 01/11/2022.
2. Ethics approval added.
04/08/2022: Internal review.
13/07/2022: Trial’s existence confirmed by the NIHR.