Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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)
Query!
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
Query!
Secondary ID [1]
308024
0
Nil Known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RAPSODI-AUS
Query!
Linked study record
None
Query!
Health condition
Health condition(s) or problem(s) studied:
Painful Shoulder Osteoarthritis
327703
0
Query!
Condition category
Condition code
Musculoskeletal
324783
324783
0
0
Query!
Osteoarthritis
Query!
Surgery
324986
324986
0
0
Query!
Surgical techniques
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
324478
0
Treatment: Surgery
Query!
Intervention code [2]
324479
0
Rehabilitation
Query!
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.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
332609
0
Query!
Timepoint [1]
332609
0
24 months post-procedure
Query!
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.
Query!
Assessment method [2]
332789
0
Query!
Timepoint [2]
332789
0
24 months post-procedure
Query!
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.
Query!
Assessment method [1]
414044
0
Query!
Timepoint [1]
414044
0
Pre-operative/baseline and at 3, 6, 12, and 18 months and over 24 months post-procedure.
Query!
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.
Query!
Assessment method [2]
414501
0
Query!
Timepoint [2]
414501
0
preoperative/baseline and 3, 6, 12 and 24 months post-procedure.
Query!
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)
Query!
Assessment method [3]
414502
0
Query!
Timepoint [3]
414502
0
24 months post procedure
Query!
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.
Query!
Assessment method [4]
414503
0
Query!
Timepoint [4]
414503
0
preoperative/baseline and 3, 6, 12 and 24 months post-procedure
Query!
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.
Query!
Assessment method [5]
414504
0
Query!
Timepoint [5]
414504
0
preoperative/baseline; and at 24 months post-procedure
Query!
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)
Query!
Assessment method [6]
414505
0
Query!
Timepoint [6]
414505
0
preoperative/baseline and at 24 months post procedure
Query!
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.
Query!
Assessment method [7]
414506
0
Query!
Timepoint [7]
414506
0
3, 6, 12 and at 24 months post-procedure
Query!
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.
Query!
Assessment method [8]
414507
0
Query!
Timepoint [8]
414507
0
3, 6, 12 and 24 months post-procedure
Query!
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.
Query!
Assessment method [9]
414508
0
Query!
Timepoint [9]
414508
0
Over 24 months post-procedure
Query!
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.
Query!
Assessment method [10]
414509
0
Query!
Timepoint [10]
414509
0
preoperative/baseline and at 3, 6, 12 and 24 months post-procedure.
Query!
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.
Query!
Assessment method [11]
414510
0
Query!
Timepoint [11]
414510
0
At 2 months and 12 months post-procedure
Query!
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.
Query!
Assessment method [12]
414714
0
Query!
Timepoint [12]
414714
0
Over 24 months post-procedure
Query!
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.
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/02/2023
Query!
Actual
3/05/2023
Query!
Date of last participant enrolment
Anticipated
1/02/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
1/02/2027
Query!
Actual
Query!
Sample size
Target
430
Query!
Accrual to date
1
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Query!
Recruitment hospital [1]
23304
0
St John of God Hospital, Geelong - Geelong
Query!
Recruitment hospital [2]
23305
0
Barwon Health - Geelong Hospital campus - Geelong
Query!
Recruitment hospital [3]
23306
0
Wagga Wagga Base Hospital - Wagga Wagga
Query!
Recruitment hospital [4]
23324
0
Gold Coast University Hospital - Southport
Query!
Recruitment hospital [5]
23325
0
Robina Hospital - Robina
Query!
Recruitment hospital [6]
25554
0
Royal Brisbane & Womens Hospital - Herston
Query!
Recruitment hospital [7]
25555
0
The Prince Charles Hospital - Chermside
Query!
Recruitment hospital [8]
25556
0
Surgical Treatment and Rehabilitation Service (STARS) - Herston
Query!
Recruitment hospital [9]
25557
0
Redcliffe Hospital - Redcliffe
Query!
Recruitment hospital [10]
26977
0
Calvary Health Care Tasmania - Hobart - Lenah Valley
Query!
Recruitment hospital [11]
26978
0
Coffs Harbour Base Hospital - Coffs Harbour
Query!
Recruitment hospital [12]
26979
0
Baringa Private Hospital - Coffs Harbour
Query!
Recruitment hospital [13]
26980
0
Sunshine Coast University Private Hospital - Birtinya
Query!
Recruitment hospital [14]
26981
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [15]
26982
0
Nambour General Hospital - Nambour
Query!
Recruitment hospital [16]
26983
0
St John of God Hospital, Murdoch - Murdoch
Query!
Recruitment hospital [17]
26984
0
Calvary Private Hospital - Wagga Wagga
Query!
Recruitment hospital [18]
26985
0
Eastern Health - Box Hill
Query!
Recruitment hospital [19]
26986
0
Maroondah Hospital - Ringwood East
Query!
Recruitment hospital [20]
26987
0
Frankston Hospital - Frankston
Query!
Recruitment hospital [21]
26988
0
St George Hospital - Kogarah
Query!
Recruitment hospital [22]
26989
0
The Sutherland Hospital - Caringbah
Query!
Recruitment postcode(s) [1]
38677
0
3220 - Geelong
Query!
Recruitment postcode(s) [2]
38680
0
4215 - Southport
Query!
Recruitment postcode(s) [3]
38697
0
4226 - Robina
Query!
Recruitment postcode(s) [4]
41376
0
4029 - Herston
Query!
Recruitment postcode(s) [5]
41377
0
4032 - Chermside
Query!
Recruitment postcode(s) [6]
41378
0
4020 - Redcliffe
Query!
Recruitment postcode(s) [7]
43052
0
7008 - Lenah Valley
Query!
Recruitment postcode(s) [8]
43053
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [9]
43054
0
4575 - Birtinya
Query!
Recruitment postcode(s) [10]
43055
0
4560 - Nambour
Query!
Recruitment postcode(s) [11]
43056
0
6150 - Murdoch
Query!
Recruitment postcode(s) [12]
43057
0
2650 - Wagga Wagga
Query!
Recruitment postcode(s) [13]
43058
0
3128 - Box Hill
Query!
Recruitment postcode(s) [14]
43059
0
3135 - Ringwood East
Query!
Recruitment postcode(s) [15]
43060
0
3199 - Frankston
Query!
Recruitment postcode(s) [16]
43061
0
2217 - Kogarah
Query!
Recruitment postcode(s) [17]
43062
0
2229 - Caringbah
Query!
Funding & Sponsors
Funding source category [1]
312288
0
Government body
Query!
Name [1]
312288
0
NHMRC
Query!
Address [1]
312288
0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Query!
Country [1]
312288
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Deakin University
Query!
Address
Deakin University
Locked Bag 20000
Geelong VIC 3220
Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
313832
0
None
Query!
Name [1]
313832
0
Query!
Address [1]
313832
0
Query!
Country [1]
313832
0
Query!
Other collaborator category [1]
282440
0
Other
Query!
Name [1]
282440
0
Australian Orthopaedic Association National Joint Replacement Registry
Query!
Address [1]
282440
0
Level 4,
South Australian Health and Medical Research Institute (SAHMRI),
North Terrace,
Adelaide SA 5000
Query!
Country [1]
282440
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
311657
0
St John of God HREC
Query!
Ethics committee address [1]
311657
0
St John of God Health Care Level 1, 556 Wellington Street Perth WA 6000
Query!
Ethics committee country [1]
311657
0
Australia
Query!
Date submitted for ethics approval [1]
311657
0
31/10/2022
Query!
Approval date [1]
311657
0
02/12/2022
Query!
Ethics approval number [1]
311657
0
Query!
Ethics committee name [2]
313391
0
Queensland Metro North HREC B
Query!
Ethics committee address [2]
313391
0
Metro North Health Human Research Ethics Committee Metro North Office of Research Level 7, Block 7, RBWH Campus Herston Qld 4029
Query!
Ethics committee country [2]
313391
0
Australia
Query!
Date submitted for ethics approval [2]
313391
0
25/01/2023
Query!
Approval date [2]
313391
0
30/06/2023
Query!
Ethics approval number [2]
313391
0
HREC/2023/MNHB/92133
Query!
Ethics committee name [3]
315983
0
Ramsay Health Care Human Research Ethics Committee A
Query!
Ethics committee address [3]
315983
0
https://www.ramsayhealth.com.au/Ramsay-Research/Reseach-Ethics-at-Ramsay
Query!
Ethics committee country [3]
315983
0
Australia
Query!
Date submitted for ethics approval [3]
315983
0
04/01/2024
Query!
Approval date [3]
315983
0
02/04/2024
Query!
Ethics approval number [3]
315983
0
HREC ID: 2024/ETH/0000
Query!
Ethics committee name [4]
315984
0
Calvary Health Care Tasmania - Chair Clinical Research and Ethics Committee -CREC
Query!
Ethics committee address [4]
315984
0
Tony Brennan Regional Director of Mission Acting Chair Clinical Research and Ethics Committee GPO Box 1523, HOBART TAS 7001
Query!
Ethics committee country [4]
315984
0
Australia
Query!
Date submitted for ethics approval [4]
315984
0
07/03/2024
Query!
Approval date [4]
315984
0
22/03/2024
Query!
Ethics approval number [4]
315984
0
n/a
Query!
Summary
Brief 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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
121882
0
Prof Richard Page
Query!
Address
121882
0
Geelong Orthopaedics
Specialist Centre
St John Of God Hospital
83 Myers Street
Geelong
Victoria 3220
Query!
Country
121882
0
Australia
Query!
Phone
121882
0
+61 3 5222 5777
Query!
Fax
121882
0
+61 3 5229 1283
Query!
Email
121882
0
[email protected]
Query!
Contact person for public queries
Name
121883
0
Dianne Buranyi-Trevarton
Query!
Address
121883
0
AOANJRR,
Level 4,
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Query!
Country
121883
0
Australia
Query!
Phone
121883
0
+61881284214
Query!
Fax
121883
0
Query!
Email
121883
0
[email protected]
Query!
Contact person for scientific queries
Name
121884
0
Dianne Buranyi-Trevarton
Query!
Address
121884
0
AOANJRR,
Level 4,
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide SA 5000
Query!
Country
121884
0
Australia
Query!
Phone
121884
0
+61881284214
Query!
Fax
121884
0
Query!
Email
121884
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF