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

NCT07193524 | Recruiting FDA Device

• 1 other identifier: 2024P003282
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

3D; Tibia fracture; Surgical Planning; Fracture Analysis

Outcome Measures

Primary Outcomes (1)

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

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

  From enrollment to day after surgery

Study Arms (1)

3D Analysis Group

EXPERIMENTAL

Device: 3D Fracture Analysis Tool

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

3D Analysis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18
• lower extremity fracture

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: September 26, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)