Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Preoperative 3D fracture analysis for planning tibial fixation

Official title: Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool

Run by Brigham and Women's Hospital · NCT07193524 · Data updated 2026-11-12

This project will try a 3D CT-based tool that helps surgeons plan screw and plate fixation for adults with complex tibial plateau fractures to see if it fits into usual care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorBrigham and Women's Hospital
Academic / other
Locations2 sites (Boston, Massachusetts and 1 other locations)
StatusRecruiting
StartedSeptember 10, 2025
Main results expectedSeptember 2027
Study endsSeptember 2028
Registry record updatedSeptember 26, 2025
Trial IDNCT07193524 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with lower extremity fractures, particularly complex tibial plateau fractures, who have preoperative CT imaging and receive care at the participating hospitals are the ideal candidates.

Probably not a fit

Patients under 18, those without preoperative CT scans, or those with simple fractures that do not require complex fixation are unlikely to benefit from this tool.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The tool creates patient-specific 3D visualizations from CT scans and uses biomechanical modeling to simulate different screw and plate fixation strategies for tibial fractures. Surgeons review simulated constructs and stability metrics preoperatively to inform their planned fixation approach. The study tests whether this workflow can be integrated into usual preoperative planning at two Boston academic centers without changing the standard of care. Feasibility outcomes focus on workflow fit, surgeon usability, and whether the tool changes preoperative plans.

Why it matters

Potential benefit: If successful, the tool could help surgeons choose more stable fixation plans, potentially reducing intraoperative uncertainty, operative time, and fixation-related complications.

How similar studies have gone: Prior work using 3D modeling and biomechanical simulation in orthopedic planning has shown promising technical results, though clear clinical outcome improvements and broad adoption are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age above 18
* lower extremity fracture

Where it's running

  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.