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

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2028

Conditions
Tibia FracturesTrauma (Including Fractures)Surgical Planning
Interventions
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"

Trial Locations (2)

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Brigham and Women's Hospital

OTHER

NCT07193524 - Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool | Biotech Hunter | Biotech Hunter