NCT07193524

Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tibia Fractures
• Trauma (Including Fractures)
• Surgical Planning

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study