RecruitingACTRN12624000724572

A comparison of x-ray imaging and low-dose computed tomography (CT) scans for ankle imaging following surgery (total ankle replacements -TARs).

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.

Sponsor

The University of Auckland

Enrollment

30 participants

Start Date

Aug 14, 2024

Study Type

Interventional

Conditions

Total ankle replacements Osteoarthritis

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Total ankle replacement (TAR) is a surgical option for people with severe ankle arthritis that preserves more movement than traditional ankle fusion. After surgery, patients typically have X-rays to check how well the implant is positioned and whether there are any complications. However, standard X-rays of ankle implants can be difficult to interpret and often require multiple attempts to get a clear image. A newer option — low-dose CT scanning — can produce three-dimensional images that may give doctors a clearer and more accurate view. This study is comparing ankle X-rays and low-dose CT scans taken six weeks after total ankle replacement surgery, to see whether CT scans identify problems or misalignments that X-rays miss, and whether they can be obtained more efficiently. Participants will receive both types of imaging at their routine six-week follow-up appointment. You may be eligible if you are 18 or older and are having a total ankle replacement at Mercy Hospital Dunedin or Te Whatu Ora Southern during the study period. Pregnant women and patients who have had significant prior radiation exposure would not be eligible.

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Interventions

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: Obser

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.