Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
- Conditions
- Fracture Malunion, BoneFractures, Bone
- Interventions
- Device: Image fusion system
- Registration Number
- NCT03764501
- Lead Sponsor
- Tokyo Medical University
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Fracture paitents need osteosynthesis
- Fracture patients under 18 years old
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Image fusion group (Image fusion) Image fusion system Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)
- Primary Outcome Measures
Name Time Method Implant choices 1month after the surgery Reproducibility of the implant choices will be evaluated.
Reduction accuracy 1month after the surgery Reproducibility of the reduction shape will be measured.
Implant placement 1month after the surgery Reproducibility of the implant placement will be evaluated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tokyo Medical University Ibaraki Medical Center
🇯🇵Ami, Ibaraki, Japan