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

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.

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Key information

Conditions

Tibia Fractures Fractures, Bone Leg Injuries Surgical Planning Tibial Fractures Trauma (Including Fractures) Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age above 18
lower extremity fracture

Treatment and study plan

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

Primary outcomes

Feasibility of incorporating the preoperative software plan based on surgeon's feedback

Time frame: From enrollment to day after surgery

Surgeons will fill out a questionnaire after the surgery to assess the clinical feasibility of the analysis tool.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Sep 26, 2025
Registry last updated: Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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