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

Sponsor
Tokyo Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03764501
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
79.4
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Image fusion system
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
Actual Study Start Date :
May 21, 2018
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.)

Outcome Measures

Primary Outcome Measures

  1. Reduction accuracy [1month after the surgery]

    Reproducibility of the reduction shape will be measured.

  2. Implant placement [1month after the surgery]

    Reproducibility of the implant placement will be evaluated.

  3. Implant choices [1month after the surgery]

    Reproducibility of the implant choices will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Fracture paitents need osteosynthesis
Exclusion Criteria:
  • Fracture patients under 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tokyo Medical University Ibaraki Medical Center Ami Ibaraki Japan 300-0395

Sponsors and Collaborators

  • Tokyo Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuichi Yoshii, Associate Professor, Department of Orthopaedic Surgery, Tokyo Medical University
ClinicalTrials.gov Identifier:
NCT03764501
Other Study ID Numbers:
  • 18-19
First Posted:
Dec 5, 2018
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fractures, Bone
Fractures, Malunited

Study Results

No Results Posted as of Apr 27, 2022