Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis (in adults 60 years and over): Differences between Interventions (RAPSODI-AUS)

INTERVENTION: 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 CONDITION: Musculoskeletal ‐ Osteoarthritis Painful Shoulder Osteoarthritis; ; Painful Shoulder Osteoarthritis Surgery ‐ Surgical techniques PRIMARY OUTCOME: Combined pain and disability score: measured via the combined SPADI score at preoperative/baseline and at 3, 6, 12, 18 months and over 24 months post‐procedure. This will be assessed as a composite outcome.[24 months post‐procedure] Patient‐reported shoulder pain and function as assessed by the combined Shoulder Pain and Disability Index (SPADI) score. ; The 13‐item SPADI is a validated and sensitive instrument for use in shoulder arthroplasty that assesses two domains; pain (5 items) and functional activities (8 items) on numerical rating scales, to provide a combined score.[24 months post‐procedure] SECONDARY OUTCOME: Change in shoulder: patient opinion about the change in their shoulder will be assessed using the global shoulder score at 24 months via the question “Compared with just before the operation for your shoulder replacement at the start of the study, how would you say that your shoulder is now?”. Responses will be on a 5‐point Likert scale with the following options: much improved, improved, same, worse, and much worse. This will only be asked at the end of the study (24 months post‐procedure)[24 months post procedure] Complications: Expected complications related to the affected shoulder will be recorded and will include (but are not limited to) deep and superficial wound infection, re‐hospitalisation, implant, nerve and skin problems. Complications (including glenoid loosening and scapula notching) will be recorded at 3, 6, 12 and 24 months post‐procedure as Surgeon‐reported Complications Case Report Forms (CRFs) in the AOANJRR online portal.[3, 6, 12 and at 24 months post‐procedure] Embedded Qualitative Study: 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. ; Interview topics will include patients’ priorities and expectations, experiences of recovery (including pain and functioning) and thoughts on the acceptability of each type of shoulder replacement. Patients’ experiences of the trial will also be explored. ; [At 2 months and 12 months post‐procedure] Health‐related quality of life: measured at 3, 6, 12 and 24 months via the EQ‐5D‐5L, a validated measure of health‐related quality of life in terms of 5 dimensions (mobility, ability to self‐care, ability to undertake usual activities, pain and discomfort, anxiety and depression) each with 5 levels of severity. The EQ‐5D‐5L will be used to calculate quality‐adjusted life years (QALYs) according to the National Institute for Health and Care Excellence (NICE) best practice guidance at the time of the analysis. [preoperative/baseline and 3, 6, 12 and 24 months post‐procedure] Individual pain and disability scores: measured via the subscale scores of the SPADI at 3, 6, 12, 18 and 24 months and over post‐procedure. This will be assessed as a composite outcome.[Pre‐operative/baseline and at 3, 6, 12, and 18 months and over 24 months post‐procedure.] Mortality Rates: Rates of patient mortality over the 24‐month follow‐up will be collected from hospital through the routine AOANJRR data and NDI linkage to identify patients where Death is not recorded in the hospital records. [Over 24 months post‐procedure] Pain and function: measured via the Oxford Shoulder Score (OSS), which is a 12‐item patient‐reported outcome measure of shoulder pain and function with 5 response categories and overall scale ranging from 0 (worst) to 48 (best). The OSS will be collected at preoperative/baseline and 3, 6, 12 and 24 months post‐procedure. [preoperative/baseline and 3, 6, 12 and 24 months post‐procedure. ] Range of shoulder movement: The range of shoulder flexion, abduction, internal and external rotation will be assessed by a suitably trained blinded assessor at 24 months using a hand‐held goniometer following trial specific instructions and recorded as continuous measurements except for internal rotation that will be assessed according to the position of the thumb to the spine. This will be assessed as a composite outcome.[preoperative/baseline; and at 24 months post‐procedure] Re‐operations: An operation to correct the complications of a previous operation due to, for example, an infection or dislocation. Re‐operations will be recorded at 3, 6, 12 and 24 months as Surgeon‐reported complications CRFs in the AOANJRR online portal. These outcomes will also be supported for completeness by the AOANJRR through normal registry reporting.[3, 6, 12 and 24 months post‐procedure] Resource use (Health economics analysis): Data on resource use will be collected to inform the economic evaluation (e.g. length of hospital stay, re‐hospitalisation, physiotherapy). Data will also be recorded about use of private care, and days lost to work and normal activities. These data will be collected from participants and hospital records at preoperative/baseline and at 3, 6, 12 and 24 months post‐procedure.[preoperative/baseline and at 3, 6, 12 and 24 months post‐procedure.] Revision Rates: Rates of implant revision over the 24‐month follow‐up will be collected from hospital through the routine AOANJRR data and National Death Inde X(NDI) linkage to identify patients in whom revision was undertaken elsewhere that is not recorded in the hospital records. A revision will be defined as for all joints in the AOANJRR which is any operation where one or more components are added to, removed or modified in a joint replacement or if a Debridement And Implant Retention (DAIR) with or without modular exchange is performed.[Over 24 months post‐procedure] Strength of shoulder: Shoulder strength will be measured at baseline and 24 months using a spring balance as described for the Constant Murley Score by a suitably trained blinded assessor. ; This will be done for both shoulders and repeated three times and will only be completed if the arm can be elevated to 90 degrees (abduction)[preoperative/baseline and at 24 months post procedure] INCLUSION CRITERIA: Inclusion criteria • Aged 60 years and over. • Diagnosis of painful osteoarthritis of the glenohumeral joint using routine radiographs not controlled by previous interventions. • An intact rotator cuff determined by pre‐operative advanced imaging (Ultrasound, MRI, or CT). • Minimal glenoid erosion determined by pre‐operative CT or other imaging in whom a non‐augmented replacement is appropriate. • Able to give informed consent.