Recruiting

Fracture Analysis Tool

Sponsor:

Brigham and Women's Hospital

Code:

NCT07193524

Conditions

Tibia Fractures

Trauma (Including Fractures)

Surgical Planning

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D Fracture Analysis Tool

Study Details

Brief 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

Study ID

NCT07193524

Start date

Sep 10, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age above 18
  • lower extremity fracture

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3D Analysis Group

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Derek Stenquist, MD

617-726-9111DSTENQUIST@mgh.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Nishant Suneja, MD

(617) 732-5465NSUNEJA@BWH.HARVARD.EDU

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • 3D
  • Tibia fracture
  • Surgical Planning
  • Fracture Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-26.