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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acromioclavicular Joint Dislocation

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

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]

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]

Presence of occult hotizontal / vertical ACJ instability not evident on plain films

Timepoint [1]

At initial presentation to orthopaedic outpatient clinic

Primary outcome [2]

Rockwood classification of ACJ injury

Timepoint [2]

At initial presentation to orthopaedic outpatient clinic

Secondary outcome [1]

Difference in sensitivity between 3D stress x-ray and Alexander view x-ray for detection of ACJ instability

Timepoint [1]

At initial presentation to orthopaedic outpatient clinic

Secondary outcome [2]

Difference in specificity between 3D stress x-ray and Alexander view x-ray for detection of ACJ instability

Timepoint [2]

At initial presentation to orthopaedic outpatient clinic

Secondary outcome [3]

Patient reported shoulder pain

Timepoint [3]

At initial presentation; and at 6 weeks, 3 months, 6 months, and 12 months since injury

Secondary outcome [4]

Patient reported shoulder instability

Timepoint [4]

At initial presentation; and at 6 weeks, 3 months, 6 months, and 12 months since injury

Secondary outcome [5]

Patient reported upper limb disability

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Alexandra Hospital - Metro South Health

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Andrew McBride - Orthopaedic Consultant at Princess Alexandra Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

https://metrosouth.health.qld.gov.au/research/about-us/hrec

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/04/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The ACJ is prone to injuries from falls, hits, and overuse, leading to ACJ injuries involving the three ligaments inside the shoulder. 
Currently patients receive CT scans and X-rays as standard of care to detect and diagnose ACJ instability. However, some findings suggest that horizontal instability is underdiagnosed using these modes of imaging, which can impact the types of treatment offered to the patient and thus negatively affect the patient’s overall outcomes. 
The Multitom RAX (Siemens Healthcare) is a twin robotic x-ray system which has movable arms allowing for imaging in the standing and lying position and further has the ability to compose 3D X-ray images similar to CT, whilst using lower ionising radiation doses compared to conventional CT. 
We postulate that 3D X-ray stress views of the ACJ could improve radiographic detection of ACJ instability and our protocol design captures this. Improvements in radiographic assessment of the condition, will benefit the patient through appropriate clinical treatment options and overall patient outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew McBride

Address

Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102

Country

Australia

Phone

+61 438 030563

Fax

[email protected]

Contact person for public queries

Name

Ciaran McDonald

Address

Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102

Country

Australia

Phone

+61 07 31762111

Fax

[email protected]

Contact person for scientific queries

Name

Ciaran McDonald

Address

Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102

Country

Australia

Phone

+61 07 31762111

Fax

[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?

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.

Trial Review

Documents added manually

Documents added automatically