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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3D Fracture Analysis Tool — DEVICE
  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

Study Details

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 Dates

Start date

Sep 10, 2025

Status verified

Sep 2025

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 3D Analysis Group

Primary Outcome Measure

Feasibility of incorporating the preoperative software plan based on surgeon's feedback [ Time Frame: From enrollment to day after surgery ]

Locations (2)

Find similar trials in Boston, MA

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