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

ConditionsTibia Fractures Trauma (Including Fractures)Surgical Planning

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age above 18

lower extremity fracture

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: 3D Analysis GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment to day after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Source ClinicalTrials.gov

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