Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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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
Trial registered on ANZCTR


Registration number
ACTRN12624000413527
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Return to sport following shoulder stabilisation surgery
Scientific title
Return to play post anterior shoulder stabilisation, a prospective observational trial assessing physical and psychological parameters affecting post operative outcomes
Secondary ID [1] 311583 0
None
Universal Trial Number (UTN)
Trial acronym
RTPPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior shoulder dislocation 332964 0
Condition category
Condition code
Musculoskeletal 329677 329677 0 0
Other muscular and skeletal disorders
Injuries and Accidents 329878 329878 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Physical testing and questionnaires
At 6 months post operatively participants will undergo physical strength testing of their shoulder, using previously validated assessment measures. These include ASH (Athletic Shoulder Test) test, SARTs (Return to sport) testing, hand held dynamometry strength testing of internal and external rotation. The questionnaires that will be used are the SIRSI (shoulder instability-return to sport after injury) and the Western Ontario Shoulder Instability Index (WOSI). The testing and questionnaires are completed within 60 minutes.
Then at 12 and 24 months participants complete a 5 minute online questionnaire assessing return to play, recurrent instability and a quality of life questionnaire (WOSI).
Intervention code [1] 328035 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337459 0
Recurrent dislocation
Assessment method [1] 337459 0
- Recurrent instability - participant selects one of the following responses. The results will be recorded as yes or no based on the response (No if select responses 1 or 2 and Yes is select responses 3, 4 or 5). Recurrent shoulder instability event 1. No - Participant has had no further episodes of shoulder instability 2. No - Participant has had pain or felt increased movement in shoulder, but shoulder has not come out of its socket 3. Yes - Shoulder has come of out its socket and was relocated without the application of external force 4. Yes - Shoulder has come out of its socket and has required assistance/the application of external force from non-medical personnel (family or friends) to relocate shoulder 5. Yes - Shoulder has come out of its socket and has required assistance of doctor (or other medical personnel) to relocate shoulder
Timepoint [1] 337459 0
12 months and 24 months operatively
Secondary outcome [1] 431953 0
Return to sport
Assessment method [1] 431953 0
- Return to sport - questionnaire made for study assessing if participant has returned to sport and if it is at a lower, same or higher level compared to preoperatively
Timepoint [1] 431953 0
12 and 24 months post-operatively
Secondary outcome [2] 433371 0
Self assessment of shoulder function for patients with a background of shoulder instability
Assessment method [2] 433371 0
WOSI questionnaire
Timepoint [2] 433371 0
baseline, 6, 12 and 24 months
Secondary outcome [3] 433591 0
Shoulder strength
Assessment method [3] 433591 0
ASH (Athletic Shoulder Test) test - this is a shoulder strength test
Timepoint [3] 433591 0
6 months only
Secondary outcome [4] 433592 0
Strength and function of shoulder
Assessment method [4] 433592 0
SARTs (Return to sport) testing - reliable and reproducible battery of 4 physical tests (line hops, push up claps, side hold rotation and ball holds with press
Timepoint [4] 433592 0
6 months only
Secondary outcome [5] 433593 0
Strength of shoulder in internal and external rotation
Assessment method [5] 433593 0
Hand held dynamometry strength testing of internal and external rotation of shoulder at both 0 and 90 degrees of abduction - reliable and reproducible
Timepoint [5] 433593 0
6 months only
Secondary outcome [6] 433594 0
Psychological readiness to return to sport
Assessment method [6] 433594 0
Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire - validated
Timepoint [6] 433594 0
6 months only

Eligibility
Key inclusion criteria
- One or more previous traumatic anterior dislocation
- Age 16 to 40 years inclusive
- Involved in weekly sport before injury
- Intending to return to weekly sport following surgery
- Undergoing anterior shoulder stabilization surgery (Arthroscopic, Open, Latarjet)
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient unable to provide informed consent
- Previous operation to the affected joint
- HAGL repair

Study design
Purpose
Screening
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
165
Accrual to date
45
Final
Recruitment outside Australia
Country [1] 26162 0
New Zealand
State/province [1] 26162 0

Funding & Sponsors
Funding source category [1] 315886 0
Charities/Societies/Foundations
Name [1] 315886 0
Taranaki Medical Foundation
Country [1] 315886 0
New Zealand
Funding source category [2] 315887 0
Charities/Societies/Foundations
Name [2] 315887 0
Wishbone Orthopaedic Rsearch Foundation
Country [2] 315887 0
New Zealand
Funding source category [3] 315888 0
Charities/Societies/Foundations
Name [3] 315888 0
New Zealand Physiotherapy Society
Country [3] 315888 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Taranaki Medical Foundation
Country
New Zealand
Secondary sponsor category [1] 318031 0
Charities/Societies/Foundations
Name [1] 318031 0
Wishbone Orthopaedic Research Foundation
Country [1] 318031 0
New Zealand
Secondary sponsor category [2] 318032 0
Charities/Societies/Foundations
Name [2] 318032 0
New Zealand Physiotherapy Society
Country [2] 318032 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314731 0
University of Otago Human Ethics Committee
Ethics committee address [1] 314731 0
Ethics committee country [1] 314731 0
New Zealand
Date submitted for ethics approval [1] 314731 0
29/03/2022
Approval date [1] 314731 0
30/03/2022
Ethics approval number [1] 314731 0
H22/022

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 132554 0
Dr Rachel Basevi
Address 132554 0
Taranaki Base Hospital, David Street, Westown, New Plymouth 4310
Country 132554 0
New Zealand
Phone 132554 0
+64 2108709924
Email 132554 0
rachel.basevi@gmail.com
Contact person for public queries
Name 132555 0
Rachel Basevi
Address 132555 0
Taranaki Base Hospital, David Street, Westown, New Plymouth 4310
Country 132555 0
New Zealand
Phone 132555 0
+64 2108709924
Email 132555 0
rachel.basevi@gmail.com
Contact person for scientific queries
Name 132556 0
Rachel Basevi
Address 132556 0
Taranaki Base Hospital, David Street, Westown, New Plymouth 4310
Country 132556 0
New Zealand
Phone 132556 0
+64 2108709924
Email 132556 0
rachel.basevi@gmail.com

Data sharing statement
Will the study consider sharing individual participant data?
No


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.