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

April 25, 2022 updated by: Yuichi Yoshii, Tokyo Medical University
Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Ibaraki
      • Ami, Ibaraki, Japan, 300-0395
        • Recruiting
        • Tokyo Medical University Ibaraki Medical Center
        • Contact:
          • Yuichi Yoshii
          • Phone Number: 81298871161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fracture paitents need osteosynthesis

Exclusion Criteria:

  • Fracture patients under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Image fusion group (Image fusion)
Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)
Device: Image fusion system
Image fusion system for the 3D preoperative planning
No Intervention: Control group (ZedTrauma)
only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction accuracy
Time Frame: 1month after the surgery
Reproducibility of the reduction shape will be measured.
1month after the surgery
Implant placement
Time Frame: 1month after the surgery
Reproducibility of the implant placement will be evaluated.
1month after the surgery
Implant choices
Time Frame: 1month after the surgery
Reproducibility of the implant choices will be evaluated.
1month after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2018

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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