Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001364763
Ethics application status
Approved
Date submitted
6/10/2022
Date registered
24/10/2022
Date last updated
25/08/2024
Date data sharing statement initially provided
24/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis (in adults 60 years and over): Differences between Interventions (RAPSODI-AUS)
Scientific title
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
Secondary ID [1] 308024 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
RAPSODI-AUS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Painful Shoulder Osteoarthritis 327703 0
Condition category
Condition code
Musculoskeletal 324783 324783 0 0
Osteoarthritis
Surgery 324986 324986 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324478 0
Treatment: Surgery
Intervention code [2] 324479 0
Rehabilitation
Comparator / control treatment
Anatomical total shoulder replacement (aTSR) is a conventional shoulder replacement which mimics the natural ball and socket structure of the joint and relies on the presence of an intact rotator cuff for useful range of movement. The metal ball is attached to the humerus, and the replacement relies on these small muscles around the shoulder joint working well. If these muscles (rotator cuff) weaken over time, further surgery may be required. The choice of implant will depend on local practice at recruiting sites but will include any anatomical shoulder implant from any manufacturer licensed for use in the Australia implanted using techniques consistent with manufacturer instructions. This type of surgery is used routinely in Australia and is anticipated to take about 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. They will receive routine post-operative care, follow up and physiotherapy, as for any other shoulder replacement surgery patient not participating in the study.
Control group
Active

Outcomes
Primary outcome [1] 332609 0
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.
Timepoint [1] 332609 0
24 months post-procedure
Primary outcome [2] 332789 0
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.
Timepoint [2] 332789 0
24 months post-procedure
Secondary outcome [1] 414044 0
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.
Timepoint [1] 414044 0
Pre-operative/baseline and at 3, 6, 12, and 18 months and over 24 months post-procedure.
Secondary outcome [2] 414501 0
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.
Timepoint [2] 414501 0
preoperative/baseline and 3, 6, 12 and 24 months post-procedure.
Secondary outcome [3] 414502 0
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)
Timepoint [3] 414502 0
24 months post procedure
Secondary outcome [4] 414503 0
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.
Timepoint [4] 414503 0
preoperative/baseline and 3, 6, 12 and 24 months post-procedure
Secondary outcome [5] 414504 0
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.
Timepoint [5] 414504 0
preoperative/baseline; and at 24 months post-procedure
Secondary outcome [6] 414505 0
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)
Timepoint [6] 414505 0
preoperative/baseline and at 24 months post procedure
Secondary outcome [7] 414506 0
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.
Timepoint [7] 414506 0
3, 6, 12 and at 24 months post-procedure
Secondary outcome [8] 414507 0
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.
Timepoint [8] 414507 0
3, 6, 12 and 24 months post-procedure
Secondary outcome [9] 414508 0
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 Index (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.
Timepoint [9] 414508 0
Over 24 months post-procedure
Secondary outcome [10] 414509 0
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.
Timepoint [10] 414509 0
preoperative/baseline and at 3, 6, 12 and 24 months post-procedure.
Secondary outcome [11] 414510 0
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.
Timepoint [11] 414510 0
At 2 months and 12 months post-procedure
Secondary outcome [12] 414714 0
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.
Timepoint [12] 414714 0
Over 24 months post-procedure

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Shoulder replacement surgery contra-indicated.
• A diagnosis of inflammatory arthritis, acute trauma or trauma sequelae.
• Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires.
• Trial participant for TSR for opposite shoulder.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the AOANJRR (holder of the allocation schedule). The allocation schedule will be generated by a senior registry statistician, otherwise not involved in the recruitment or randomisation of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be 1:1, using random permuted blocks of random block size, stratified by age (60-69; 70+) as a surrogate of deteriorating shoulder rotator cuff function.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary comparison of interest is the between-groups difference in SPADI score at 24 months. To make use of all available observations from all time-points in the trial, the estimate for the difference at 24 months will be derived from a constrained longitudinal data analysis (cLDA) model. The model will be a linear mixed-effects model, featuring SPADI score as the outcome, intervention group, time-point (coded as dummy variables to denote the baseline, 3, 6, 12, 18, or 24-month time-points), age and gender as fixed effects, and participant identifier and study site as random effects. A series of group-by-time point interaction effects will be included as fixed effects, thereby making no assumptions about the shape of the SPADI score trajectory over time. The model will be constrained so that the baseline SPADI scores are equal between groups. The model will use maximum likelihood estimation, with an unstructured covariance matrix. The between-groups difference in SPADI score at 24 months will be extracted from this model as the primary outcome and reported with a 95% CI and p-value.

The between-group differences for combined SPADI score at 3, 6, 12 and 18 months, and over 24 months will also be extracted from the primary analysis model as secondary outcomes. The other secondary continuous outcomes (e.g. SPADI pain and function subscale scores, OSS) will be analysed using an identical mixed-effects model to the primary outcome analysis, with the same covariates and covariance structure. The outcome in these models will be replaced with each of the secondary outcomes of interest. The OSS model will not feature an 18-month time point, as this outcome is not collected at this time. While also a continuous secondary outcome, the EQ-5D-5L will exclusively be used in the economic evaluation.
Range of movement and strength are collected at two time-points (baseline and 24 months). The 24-month outcomes for these measures will be compared via a mixed-effects linear regression model with intervention group as the predictor variable, as well as age, gender and baseline value of the outcome, and site as a random effect.
The ordinal outcome of global shoulder score at 24 months will be analysed using mixed-effects ordinal logistic regression, adjusting for age, gender, and baseline combined SPADI score, with site as a random effect.
Time-to-event outcomes (time to revision/re-operation/death) will be explored by comparing restricted mean survival times between intervention groups (as we suspect that proportional hazards-type analyses may be inappropriate for these outcomes).
Safety outcomes (adverse event rate, complication rate and types of complication) will be summarised across all time-points at which they are collected.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
3/05/2023
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
430
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment hospital [1] 23304 0
St John of God Hospital, Geelong - Geelong
Recruitment hospital [2] 23305 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [3] 23306 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [4] 23324 0
Gold Coast University Hospital - Southport
Recruitment hospital [5] 23325 0
Robina Hospital - Robina
Recruitment hospital [6] 25554 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [7] 25555 0
The Prince Charles Hospital - Chermside
Recruitment hospital [8] 25556 0
Surgical Treatment and Rehabilitation Service (STARS) - Herston
Recruitment hospital [9] 25557 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [10] 26977 0
Calvary Health Care Tasmania - Hobart - Lenah Valley
Recruitment hospital [11] 26978 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [12] 26979 0
Baringa Private Hospital - Coffs Harbour
Recruitment hospital [13] 26980 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [14] 26981 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [15] 26982 0
Nambour General Hospital - Nambour
Recruitment hospital [16] 26983 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [17] 26984 0
Calvary Private Hospital - Wagga Wagga
Recruitment hospital [18] 26985 0
Eastern Health - Box Hill
Recruitment hospital [19] 26986 0
Maroondah Hospital - Ringwood East
Recruitment hospital [20] 26987 0
Frankston Hospital - Frankston
Recruitment hospital [21] 26988 0
St George Hospital - Kogarah
Recruitment hospital [22] 26989 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 38677 0
3220 - Geelong
Recruitment postcode(s) [2] 38680 0
4215 - Southport
Recruitment postcode(s) [3] 38697 0
4226 - Robina
Recruitment postcode(s) [4] 41376 0
4029 - Herston
Recruitment postcode(s) [5] 41377 0
4032 - Chermside
Recruitment postcode(s) [6] 41378 0
4020 - Redcliffe
Recruitment postcode(s) [7] 43052 0
7008 - Lenah Valley
Recruitment postcode(s) [8] 43053 0
2450 - Coffs Harbour
Recruitment postcode(s) [9] 43054 0
4575 - Birtinya
Recruitment postcode(s) [10] 43055 0
4560 - Nambour
Recruitment postcode(s) [11] 43056 0
6150 - Murdoch
Recruitment postcode(s) [12] 43057 0
2650 - Wagga Wagga
Recruitment postcode(s) [13] 43058 0
3128 - Box Hill
Recruitment postcode(s) [14] 43059 0
3135 - Ringwood East
Recruitment postcode(s) [15] 43060 0
3199 - Frankston
Recruitment postcode(s) [16] 43061 0
2217 - Kogarah
Recruitment postcode(s) [17] 43062 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 312288 0
Government body
Name [1] 312288 0
NHMRC
Country [1] 312288 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Locked Bag 20000
Geelong VIC 3220
Australia
Country
Australia
Secondary sponsor category [1] 313832 0
None
Name [1] 313832 0
Address [1] 313832 0
Country [1] 313832 0
Other collaborator category [1] 282440 0
Other
Name [1] 282440 0
Australian Orthopaedic Association National Joint Replacement Registry
Address [1] 282440 0
Level 4,
South Australian Health and Medical Research Institute (SAHMRI),
North Terrace,
Adelaide SA 5000
Country [1] 282440 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311657 0
St John of God HREC
Ethics committee address [1] 311657 0
Ethics committee country [1] 311657 0
Australia
Date submitted for ethics approval [1] 311657 0
31/10/2022
Approval date [1] 311657 0
02/12/2022
Ethics approval number [1] 311657 0
Ethics committee name [2] 313391 0
Queensland Metro North HREC B
Ethics committee address [2] 313391 0
Ethics committee country [2] 313391 0
Australia
Date submitted for ethics approval [2] 313391 0
25/01/2023
Approval date [2] 313391 0
30/06/2023
Ethics approval number [2] 313391 0
HREC/2023/MNHB/92133
Ethics committee name [3] 315983 0
Ramsay Health Care Human Research Ethics Committee A
Ethics committee address [3] 315983 0
Ethics committee country [3] 315983 0
Australia
Date submitted for ethics approval [3] 315983 0
04/01/2024
Approval date [3] 315983 0
02/04/2024
Ethics approval number [3] 315983 0
HREC ID: 2024/ETH/0000
Ethics committee name [4] 315984 0
Calvary Health Care Tasmania - Chair Clinical Research and Ethics Committee -CREC
Ethics committee address [4] 315984 0
Ethics committee country [4] 315984 0
Australia
Date submitted for ethics approval [4] 315984 0
07/03/2024
Approval date [4] 315984 0
22/03/2024
Ethics approval number [4] 315984 0
n/a

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121882 0
Prof Richard Page
Address 121882 0
Geelong Orthopaedics
Specialist Centre
St John Of God Hospital
83 Myers Street
Geelong
Victoria 3220
Country 121882 0
Australia
Phone 121882 0
+61 3 5222 5777
Fax 121882 0
+61 3 5229 1283
Email 121882 0
richard.page@deakin.edu.au
Contact person for public queries
Name 121883 0
Dianne Buranyi-Trevarton
Address 121883 0
AOANJRR,
Level 4,
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Country 121883 0
Australia
Phone 121883 0
+61881284214
Fax 121883 0
Email 121883 0
ethics@aoanjrr.org.au
Contact person for scientific queries
Name 121884 0
Dianne Buranyi-Trevarton
Address 121884 0
AOANJRR,
Level 4,
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Country 121884 0
Australia
Phone 121884 0
+61881284214
Fax 121884 0
Email 121884 0
ethics@aoanjrr.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.