3D Fracture Analysis Tool for Broken Leg

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for individuals with specific leg injuries: peroneal nerve injury, diaphyseal tibial fractures, or a broken leg. It's focused on those needing preoperative planning before screw and plate fixation surgery.

Inclusion Criteria

I am over 18 years old.

I have a broken bone in my leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Planning

Evaluation of a preoperative fracture analysis tool using 3D visualization and biomechanical modeling to assist in surgical planning

1 week

Surgery

Surgical procedure using the preoperative plan developed with the analysis tool

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery, including feedback on the tool's feasibility

1 week

What Are the Treatments Tested in This Trial?

Interventions

• 3D Fracture Analysis Tool

Trial Overview The study tests a new 3D Fracture Analysis Tool designed to help surgeons plan complex bone surgeries. Using patient CT scans, it simulates different surgical strategies to find the most stable fix without changing usual treatment.

How Is the Trial Designed?

Group I: 3D Analysis Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+