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Utility of image fusion system for the fracture and fracture malunion management will be evaluated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image fusion group (Image fusion) | Active Comparator | Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.) |
|
| Control group (ZedTrauma) | No Intervention | only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image fusion system | Device | Image fusion system for the 3D preoperative planning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction accuracy | Reproducibility of the reduction shape will be measured. | 1month after the surgery |
| Implant placement | Reproducibility of the implant placement will be evaluated. | 1month after the surgery |
| Implant choices | Reproducibility of the implant choices will be evaluated. | 1month after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuichi M Yoshii | Contact | 81298871161 | 81298871161 | yy12721@yahoo.co.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical University Ibaraki Medical Center | Recruiting | Ami | Ibaraki | 300-0395 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34193171 | Derived | Yoshii Y, Ogawa T, Hara Y, Totoki Y, Ishii T. An image fusion system for corrective osteotomy of distal radius malunion. Biomed Eng Online. 2021 Jun 30;20(1):66. doi: 10.1186/s12938-021-00901-8. | |
| 31694677 | Derived | Yoshii Y, Totoki Y, Sashida S, Sakai S, Ishii T. Utility of an image fusion system for 3D preoperative planning and fluoroscopy in the osteosynthesis of distal radius fractures. J Orthop Surg Res. 2019 Nov 6;14(1):342. doi: 10.1186/s13018-019-1370-z. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D017759 | Fractures, Malunited |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
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