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

Primary Purpose

Fractures, Bone, Fracture Malunion, Bone

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Image fusion system
Sponsored by
Tokyo Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fracture paitents need osteosynthesis

Exclusion Criteria:

  • Fracture patients under 18 years old

Sites / Locations

  • Tokyo Medical University Ibaraki Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Image fusion group (Image fusion)

Control group (ZedTrauma)

Arm Description

Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)

only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.)

Outcomes

Primary Outcome Measures

Reduction accuracy
Reproducibility of the reduction shape will be measured.
Implant placement
Reproducibility of the implant placement will be evaluated.
Implant choices
Reproducibility of the implant choices will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2018
Last Updated
April 25, 2022
Sponsor
Tokyo Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03764501
Brief Title
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
Official Title
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone, Fracture Malunion, Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Image fusion group (Image fusion)
Arm Type
Active Comparator
Arm Description
Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)
Arm Title
Control group (ZedTrauma)
Arm Type
No Intervention
Arm Description
only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.)
Intervention Type
Device
Intervention Name(s)
Image fusion system
Intervention Description
Image fusion system for the 3D preoperative planning
Primary Outcome Measure Information:
Title
Reduction accuracy
Description
Reproducibility of the reduction shape will be measured.
Time Frame
1month after the surgery
Title
Implant placement
Description
Reproducibility of the implant placement will be evaluated.
Time Frame
1month after the surgery
Title
Implant choices
Description
Reproducibility of the implant choices will be evaluated.
Time Frame
1month after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fracture paitents need osteosynthesis Exclusion Criteria: Fracture patients under 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuichi M Yoshii
Phone
81298871161
Ext
81298871161
Email
yy12721@yahoo.co.jp
Facility Information:
Facility Name
Tokyo Medical University Ibaraki Medical Center
City
Ami
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Yoshii
Phone
81298871161

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34193171
Citation
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.
Results Reference
derived
PubMed Identifier
31694677
Citation
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.
Results Reference
derived

Learn more about this trial

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

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