NCT03764501

Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tokyo Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

Detailed description

The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.

Conditions

• Fractures, Bone
• Fracture Malunion, Bone

Interventions

Type	Name	Description
DEVICE	Image fusion system	Image fusion system for the 3D preoperative planning

Timeline

• Start date: 2018-05-21
• Primary completion: 2024-03-31
• Completion: 2024-12-31
• First posted: 2018-12-05
• Last updated: 2022-04-27

Locations

1 site across 1 country: Japan