Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000397415p
Ethics application status
Submitted, not yet approved
Date submitted
15/04/2025
Date registered
2/05/2025
Date last updated
2/05/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Dynamic 3D X-Ray in the Evaluation of Acromioclavicular Joint (ACJ) Dislocations
Scientific title
Ability to Detect Acromioclavicular Joint (ACJ) Dislocations using Dynamic 3D Stress X-Ray compared to 2D Alexander View X-Ray in the Outpatient Orthopaedic Department
Secondary ID [1] 314173 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromioclavicular Joint Dislocation 337026 0
Condition category
Condition code
Musculoskeletal 333479 333479 0 0
Other muscular and skeletal disorders
Injuries and Accidents 333611 333611 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dynamic 3D stress x-rays of bilateral shoulders using a twin robotic x-ray scanner (Multitom Rax, Siemens Healthcare), performed in the Princess Alexandra Hospital (PAH) orthopaedic outpatient setting at an initial appointment that is less than 3-weeks since time of injury. Following inclusion and at an outpatient appointment less than 3-weeks since time of injury, patient's will have history and clinical examination of the shoulders recorded by an orthopaedic fellow or consultant trained in the methods of the study, at this appointment they will also have a 3D stress and 3D non-stress x-ray of both shoulders (4 x-rays in total, 2 X-rays per shoulder) using the Multitom RAX scanner as part of the intervention. These images are expected to take no more than 30-minutes in total and will be performed by a trained radiographer who is both trained in the methods of the study and operation of the Multitom RAX scanner. The order of images will be at the discretion of the radiographer based on factors such as machine availability and work-flow.
All patient's will be included in the intervention and comparator groups using a crossover method, with comparator images (2D Alexander view x-ray) taken immediately before or after the intervention images. Repeat images at subsequent outpatient appointments will not be performed for the purpose of this study.
All images will then be reviewed by a radiology fellow or consultant who is trained in the methods of the study.
Intervention code [1] 330776 0
Diagnosis / Prognosis
Comparator / control treatment
For all imaging modalities, the patient's reported injured shoulder will be compared to their uninjured shoulder in order to assess the presence or absence of vertical and horizontal ACJ instability.
Presence or absence of vertical and horizontal ACJ instability on 2D Alexander view x-ray (gold standard) will be used to compare to the results of dynamic 3D stress x-ray of the shoulder within patients, using a crossover method
Patient reported outcome measures including visual analog scale (VAS) for pain; disability of the arm, shoulder and hand score (DASH); and oxford shoulder instability score (OSIS) will be recorded using patient completed questionnaires at first appointment following inclusion, 6-weeks, 3-months, 6-months, and 1-year post shoulder injury.
Control group
Active

Outcomes
Primary outcome [1] 341123 0
Presence of occult hotizontal / vertical ACJ instability not evident on plain films
Timepoint [1] 341123 0
At initial presentation to orthopaedic outpatient clinic
Primary outcome [2] 341124 0
Rockwood classification of ACJ injury
Timepoint [2] 341124 0
At initial presentation to orthopaedic outpatient clinic
Secondary outcome [1] 446365 0
Difference in sensitivity between 3D stress x-ray and Alexander view x-ray for detection of ACJ instability
Timepoint [1] 446365 0
At initial presentation to orthopaedic outpatient clinic
Secondary outcome [2] 446366 0
Difference in specificity between 3D stress x-ray and Alexander view x-ray for detection of ACJ instability
Timepoint [2] 446366 0
At initial presentation to orthopaedic outpatient clinic
Secondary outcome [3] 446715 0
Patient reported shoulder pain
Timepoint [3] 446715 0
At initial presentation; and at 6 weeks, 3 months, 6 months, and 12 months since injury
Secondary outcome [4] 446716 0
Patient reported shoulder instability
Timepoint [4] 446716 0
At initial presentation; and at 6 weeks, 3 months, 6 months, and 12 months since injury
Secondary outcome [5] 446717 0
Patient reported upper limb disability
Timepoint [5] 446717 0
At initial presentation; and at 6 weeks, 3 months, 6 months, and 12 months since injury

Eligibility
Key inclusion criteria
Patients 18-years-old and over, presenting to orthopaedic outpatient clinic with acute ACJ injuries with capacity to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Injury >3 weeks ago
Younger than 18-years old
Pregnancy
No Capacity to consent
Claustrophobia
Inability to perform stress exam (gentle placement of hand on opposite shoulder)
History of injury to contralateral ACJ
Concomitant injury to superior shoulder suspensory complex
Rockwood type 1 or type 2 injury as determined by imaging performed by Emergency Department
Presence of metal hardware within the neck and thoracic region

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2025
Actual
Date of last participant enrolment
Anticipated
6/05/2027
Actual
Date of last data collection
Anticipated
6/05/2028
Actual
Sample size
Target
73
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27736 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43926 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 318689 0
Hospital
Name [1] 318689 0
Princess Alexandra Hospital - Metro South Health
Country [1] 318689 0
Australia
Primary sponsor type
Individual
Name
Andrew McBride - Orthopaedic Consultant at Princess Alexandra Hospital
Address
Country
Australia
Secondary sponsor category [1] 321119 0
None
Name [1] 321119 0
Address [1] 321119 0
Country [1] 321119 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317300 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317300 0
Ethics committee country [1] 317300 0
Australia
Date submitted for ethics approval [1] 317300 0
17/04/2025
Approval date [1] 317300 0
Ethics approval number [1] 317300 0

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

Contacts
Principal investigator
Name 140614 0
Dr Andrew McBride
Address 140614 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 140614 0
Australia
Phone 140614 0
+61 438 030563
Fax 140614 0
Email 140614 0
[email protected]
Contact person for public queries
Name 140615 0
Ciaran McDonald
Address 140615 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 140615 0
Australia
Phone 140615 0
+61 07 31762111
Fax 140615 0
Email 140615 0
[email protected]
Contact person for scientific queries
Name 140616 0
Ciaran McDonald
Address 140616 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 140616 0
Australia
Phone 140616 0
+61 07 31762111
Fax 140616 0
Email 140616 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After completion of first data analysis
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.