Fracture Malunion, Bone, Fractures, Bone
Conditions
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.
Interventions
DEVICEImage fusion system
Image fusion system for the 3D preoperative planning
Sponsors
Tokyo Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fracture paitents need osteosynthesis
Exclusion criteria
* Fracture patients under 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Implant choices | 1month after the surgery | Reproducibility of the implant choices will be evaluated. |
Countries
Japan
Contacts
Primary ContactYuichi M Yoshii
Outcome results
None listed