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

NCT ID: NCT03764501

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fractures, Bone Fracture Malunion, Bone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Image fusion group (Image fusion)

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

Group Type ACTIVE_COMPARATOR

Image fusion system

Intervention Type DEVICE

Image fusion system for the 3D preoperative planning

Control group (ZedTrauma)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Image fusion system

Image fusion system for the 3D preoperative planning

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fracture paitents need osteosynthesis

Exclusion Criteria

* Fracture patients under 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tokyo Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yuichi Yoshii

Associate Professor, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuichi M Yoshii

Role: CONTACT

81298871161 ext. 81298871161

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuichi Yoshii

Role: primary

81298871161

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34193171 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31694677 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.