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Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool
Sponsor: Brigham and Women's Hospital
Summary
This study aims to evaluate a preoperative fracture analysis tool that uses 3D visualization and biomechanical modeling to assist surgeons in planning screw and plate fixation for complex tibial plateau fractures. By simulating different fixation strategies based on patient-specific CT data, the tool provides insights into construct stability, potentially improving surgical precision and reducing intraoperative uncertainty. The study also investigates the tool's feasibility within current clinical workflows without altering the standard of care.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-10
Completion Date
2028-09
Last Updated
2025-09-26
Healthy Volunteers
No
Interventions
3D Fracture Analysis Tool
Based on a pre-operative computed tomography (CT) scan, fractured bone fragments of a proximal tibia are segmented and aligned to achieve adequate fracture reduction. Bone material properties for each fragment are derived from Hounsfield Units (HU) of the CT scan, based on internal density calibration with air, fat, muscle, and cortical bone. Screws and implants are then modelled based on the manufacturer's design and material properties Placement of off-the-shelf plate and screws can be analyzed and support a personalized plan on how to individually treat a patient with a specific fracture pattern and anatomical biometric data. Surgeons can define up to three approaches (different placement of implants and screws) to be visualized and analyzed for construct stability. The surgeons will receive a visualization of the fracture, fracture-reduction, implant and screw placement in 3D as well as a comparison of construct stabilites of the submitted approaches
Locations (2)
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States