CORI 2D-3D Hip Pre-Op Planner
Research type
Research Study
Full title
CORI 2D-3D CORI Hip Pre-Op Planner: Relating 3D Volume with 2D Projection Space Cohort Observation Study
IRAS ID
350773
Contact name
Craig White
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
This is a single site, prospective, basic science, observational imaging study to support a premarket notification (510(k)) submission, capturing x-rays from patients undergoing total hip arthroplasty (THA) to validate the accuracy of a 2D-3D pre-operative planner.
Accurate planning before THA can positively impact patient outcomes by improving implant sizing and positioning, and predicting the risk of future complications (e.g., fracture and dislocation). Currently, this planning involves manual measurements and using x-rays which takes a lot of time and is not very accurate. 3D imaging (e.g., CT scans) can be used but this takes much longer, does not allow for pelvic measurements and increases radiation exposure to patients.
This study aims to test an artificial intelligence (AI) planner to check how successful it is in converting 2D x-ray images into a 3D model that can be used to plan surgery. This AI model has been trained using synthetic x-rays generated from freely available pelvic CT scans.
Adult patients between 18 and 80, on the waiting list to receive a THA within 6 months will be eligible. Patients with existing metal implants will also be eligible to ensure that the AI planner can successfully learn to produce a 3D model in this common situation.
Participants will attend a radiology clinic for 4 functional x-rays and 1 CT scan and complete a short medical history questionnaire. These images can be used for their upcoming surgery and clinical care will not be changed.
The study will last around 15 months, from first recruited participant to collaborative write-up of the final report. All patient identifiable data will be anonymised before being transferred to Smith & Nephew, Inc. for analysis.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0105
Date of REC Opinion
15 May 2025
REC opinion
Further Information Favourable Opinion