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Use of Dynamic 3D X-Ray in the Evaluation of Acromioclavicular Joint (ACJ) Dislocations

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000397415
Enrollment
73
Registered
2025-05-02
Start date
2025-05-06
Completion date
2027-05-06
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 th

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.

Sponsors

Andrew McBride - Orthopaedic Consultant at Princess Alexandra Hospital
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients 18-years-old and over, presenting to orthopaedic outpatient clinic with acute ACJ injuries with capacity to consent

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026