Actively Recruiting
Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool
Led by Brigham and Women's Hospital · Updated on 2025-09-26
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a preoperative fracture analysis tool designed to assist surgeons in planning screw and plate fixation for complex tibial plateau fractures. This tool uses 3D visualization and biomechanical modeling based on patient-specific CT scans to simulate different fixation strategies. The study aims to explore the tool's ability to improve surgical planning by providing insights into construct stability and reducing uncertainty during surgery, while assessing its feasibility in current clinical workflows without changing standard care. The intervention involves a 3D fracture analysis device that segments and aligns fractured bone fragments from preoperative CT scans of the proximal tibia. Bone material properties are derived from the CT data, and screws and implants are modeled based on manufacturer designs. Surgeons can define up to three different implant placement approaches, which are visualized in 3D and analyzed for stability to support personalized surgical planning. Participants will be involved from enrollment through the day after surgery, during which the feasibility of incorporating the software's surgical plan will be evaluated based on surgeon feedback. The study monitors how well the tool fits into surgical workflows without affecting standard treatment. This approach helps researchers measure the practical use of the analysis tool during real surgical cases involving lower extremity fractures, focusing on tibia fractures.
CONDITIONS
Brief Title
Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 18
- Lower extremity fracture
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment to day after surgery
Participants undergo a preoperative 3D fracture analysis using a specialized software tool based on their CT scans to plan surgical treatment.
1 visit (in-person) before surgery and 1 visit (in-person) day after surgery
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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