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Trial registered on ANZCTR


Registration number
ACTRN12624000724572
Ethics application status
Approved
Date submitted
17/05/2024
Date registered
12/06/2024
Date last updated
2/09/2024
Date data sharing statement initially provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of x-ray imaging and low-dose computed tomography (CT) scans for ankle imaging following surgery (total ankle replacements -TARs).
Scientific title
A Comparative Analysis of Six Week Postoperative Ankle X-rays and Low-Dose Computed Tomography (CT) Scans for Evaluation of Total Ankle Replacement Complications, Prosthesis Alignment and the Radiation Dose Delivered.
Secondary ID [1] 312137 0
Nil known
Universal Trial Number (UTN)
U1111-1307-9431
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total ankle replacements 333791 0
Osteoarthritis 333792 0
Condition category
Condition code
Surgery 330463 330463 0 0
Other surgery
Musculoskeletal 330484 330484 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition observed: Patients undergoing Total Ankle Replacement (TAR) surgery.

Exposure: Post-operative imaging with low dose CT scan.
Brief name: Low Dose CT imaging.
Procedure/Activities: Observation of patients undergoing post-operative ankle CT imaging.
Who delivers the Intervention: Radiographer (Medical Imaging Technologist) will acquire the images and the radiologist will report the images.
Mode of Delivery: In-person, in the hospital Radiology Department.
Number of times delivered: Once, at six weeks following surgery.
Location: Mercy Hospital, Radiology Department
Duration of Observation: the CT scan is expected to last about 10 mins.

Scan Procedures for Participants
X-ray Imaging
-Participants will be positioned to get clear images of their ankles. This usually means standing on a flat surface, sometimes with slight adjustments to angle the foot properly.
- The X-ray process is quick, usually just a few minutes.

CT Imaging
- Participants will lie on a table that slides into the CT scanner.
- The scanner takes detailed cross-sectional images of the ankle.
- The process is non-invasive and takes about 10-15 minutes.

No injection of tracer/imaging agents will be used.

Monitoring Adherence

Electronic Medical Records (EMRs)
- We'll use EMRs to track and document all your imaging procedures.
- This includes recording dates and times of scans

Follow-ups
- Patients will have a scheduled follow-up visit approximately one week following their imaging to ensure the post-operative imaging is completed and to discuss any findings with their surgeon.
- Our study coordinator will send reminders and check in to ensure everything is on track.
Intervention code [1] 328586 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.

Low dose CT scans will be compared to ankle x-ray imaging. All participants will have their routine six week post-operative x-rays. Additionally, they will have a CT ankle scan. The findings of the x-rays and the CT scans will be compared. Currently, ankle x-rays only are performed at six weeks following a total ankle replacement. A CT scan would only be considered for patients who were having problems with their ankle replacement. The ankle x-rays will be taken in a weight-bearing position.
Control group
Active

Outcomes
Primary outcome [1] 338240 0
Compare low-dose ankle CT scans to ankle X-ray imaging as a baseline imaging modality to assess the alignment of a TAR six weeks following a TAR.
Timepoint [1] 338240 0
6 weeks following surgery (baseline)
Primary outcome [2] 338262 0
Compare the radiation dose of a two-view ankle x-ray imaging and a low-dose ankle CT scan.
Timepoint [2] 338262 0
6 weeks following surgery (baseline)
Primary outcome [3] 338349 0
To compare low-dose ankle CT scans to ankle X-ray imaging as a baseline imaging modality to assess postoperative complications of a TAR six weeks post-surgery
Timepoint [3] 338349 0
6 weeks following surgery (baseline)
Secondary outcome [1] 435571 0
There are no secondary outcomes
Timepoint [1] 435571 0
Nil

Eligibility
Key inclusion criteria
All patients undergoing a total ankle replacement surgery at Mercy Hospital Dunedin (New Zealand) or Te Whata Ora Southern between the 29th of July 2024 and the 2nd of April 2025. This is the timeframe of the study. All patients having a TAR during this time will have the opportunity to participate in the study. Patients must be 18 years or older. Patients must be able and willing to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women will be excluded from the study due to radiation dose concerns. However, this is unlikely as most patients expect to be past child-bearing age. Patients who are unable/unwilling to give consent. Patients who have been exposed to a large amount of radiation previously.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Consultation was made with the statistician from the University of Auckland. The sample size calculation has been meticulously planned to ensure inclusivity and representativeness. This approach aims to capture a comprehensive snapshot of the patient population, enhancing the study's validity i.e. all patients who have a TAR during the study period will be invited to participate in the study. Additionally, TARs are not performed every week; therefore, advice was sought to ensure that the study is statistically significant. It was concluded that enough data could be collected over a period of 8-10 months for a statistically significant study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
14/08/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
11/04/2025
Actual
Sample size
Target
30
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 26307 0
New Zealand
State/province [1] 26307 0
Otago

Funding & Sponsors
Funding source category [1] 316498 0
Other
Name [1] 316498 0
Radiology Holding Company New Zealand (RHCNZ)
Country [1] 316498 0
New Zealand
Funding source category [2] 316515 0
Other
Name [2] 316515 0
New Zealand Institute of Medical Radiation Technologists
Country [2] 316515 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318789 0
None
Name [1] 318789 0
Address [1] 318789 0
Country [1] 318789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315290 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315290 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 315290 0
New Zealand
Date submitted for ethics approval [1] 315290 0
15/04/2024
Approval date [1] 315290 0
25/07/2024
Ethics approval number [1] 315290 0
Study ID: 19766

Summary
Brief summary
The purpose of this project is to compare ankle x-ray imaging and low-dose computed tomography (CT) scans for the evaluation of total ankle replacements after surgery. Currently, ankle x-rays are performed six weeks following surgery. They are sub-optimal due to how the images are taken and presented and generally require several attempts before the correct image is obtained. With the current advanced technology of CT, three-dimensional imaging can be obtained at a low dose. CT scans could potentially assess the alignment of the implant more accurately, identify more complications and/or identify complications more quickly.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134242 0
Dr Dr. Sibusiso Mdletshe
Address 134242 0
The University of Auckland, Level B, Room B38C, M&HS Building 505, 85 Park Rd, GRAFTON, AUCKLAND, 1023.
Country 134242 0
New Zealand
Phone 134242 0
+6421327469
Fax 134242 0
Email 134242 0
[email protected]
Contact person for public queries
Name 134243 0
Ashleigh Hammer
Address 134243 0
Pacific Radiology, 72 Newington Avenue, Dunedin 9011
Country 134243 0
New Zealand
Phone 134243 0
+64 278565103
Fax 134243 0
Email 134243 0
[email protected]
Contact person for scientific queries
Name 134244 0
Dr. Sibusiso Mdletshe
Address 134244 0
The University of Auckland, Level B, Room B38C, M&HS Building 505, 85 Park Rd, GRAFTON, AUCKLAND, 1023.
Country 134244 0
New Zealand
Phone 134244 0
+6421327469
Fax 134244 0
Email 134244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The decision not to share IPD is due to concerns regarding patient privacy and confidentiality. Despite de-identification efforts, there remains a risk of re-identification, which could compromise the privacy of participants. Additionally, there are no current plans or infrastructure in place to support the secure and ethical sharing of this 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.