Preoperative 3D fracture analysis for planning tibial fixation
Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07193524 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age above 18 * lower extremity fracture
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.