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

Mass General Brigham

Status: Enrolling

Conditions: Tibia Fractures; Surgical Planning; Trauma (Including Fractures)

Treatments: Device: 3D Fracture Analysis Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07193524

2024P003282

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age above 18
• lower extremity fracture

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

3D Analysis Group

Experimental group

Treatment:

Device: 3D Fracture Analysis Tool