An interventional study of 3D Fracture Analysis Tool in Tibia Fractures, Trauma (Including Fractures) and Surgical Planning, sponsored by Brigham and Women's Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 40 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Device: 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
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
Plan to share: Yes — IPD used in the results publication.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brigham and Women's Hospital