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NCT03764501 Clinical Trial

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

Fractures, Bone Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03764501
Other study ID # 18-19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 21, 2018
Est. completion date December 31, 2024

Study information
Verified date April 2022
Source Tokyo Medical University
Contact Yuichi M Yoshii
Phone 81298871161
Email yy12721@yahoo.co.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Fracture paitents need osteosynthesis Exclusion Criteria: - Fracture patients under 18 years old

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Image fusion system
Image fusion system for the 3D preoperative planning

Locations
Country Name City State
Japan Tokyo Medical University Ibaraki Medical Center Ami Ibaraki

Sponsors (1)
Lead Sponsor Collaborator
Tokyo Medical University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction accuracy Reproducibility of the reduction shape will be measured. 1month after the surgery
Primary Implant placement Reproducibility of the implant placement will be evaluated. 1month after the surgery
Primary Implant choices Reproducibility of the implant choices will be evaluated. 1month after the surgery
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