Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis
Research type
Research Study
Full title
Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis - Differences between Interventions: a multi-centre, pragmatic, parallel group, superiority randomised controlled trial
IRAS ID
313848
Contact name
Ian A Trail
Contact email
Sponsor organisation
Wrightington, Wigan & Leigh NHS Foundation Trust
ISRCTN Number
ISRCTN12216466
Duration of Study in the UK
5 years, 1 months, 30 days
Research summary
RAPSODI aims find the best type of joint replacement for the treatment of painful shoulder osteoarthritis. With increasing age, shoulder osteoarthritis is common and causes severe pain and stiffness making everyday activities difficult. After trying non-surgical treatments, a shoulder replacement may be offered, of which there are two types: Anatomic Total Shoulder Replacement (aTSR) which retains the normal shoulder joint anatomy and relies on the tendons (Rotator Cuff) around the shoulder being intact and functional. Alternatively, a Reverse Total Shoulder Replacement (rTSR) is usually used when the rotator cuff becomes weaker or torn.
The most common reason for revision of aTSR is rotator cuff failure. Increasingly in patients aged 60 years and older, surgeons offer a rTSR even when the patient’s rotator cuff is intact. To date there are no randomised controlled trials (RCT) comparing the two types of implant in this patient group, and no guidance to recommend if one type of shoulder joint replacement is superior for patient outcomes.
We aim to recruit 430 patients who are aged 60 years or over who have a diagnosis of painful shoulder osteoarthritis and a functional rotator cuff across a minimum of 28 NHS sites in England, Wales and Northern Ireland. We will investigate if rTSR is superior to aTSR as primarily measured by patient rated pain and function using the Shoulder Pain and Disability Index (SPADI) at 24 months, and whether this is a cost-effective treatment option. Secondary outcomes include assessment of adverse events, global change, range of movement, and strength. It includes an eight-month internal pilot as well as a full health economic analysis, data linkage to the National Joint Registry, and a nested qualitative interview study to explore patients' experiences of the two types of replacement and their recovery.REC name
London - Queen Square Research Ethics Committee
REC reference
22/LO/0617
Date of REC Opinion
4 Oct 2022
REC opinion
Further Information Favourable Opinion