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

NCT03764501 | Unknown

• 1 other identifier: 18-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fractures, Bone; Fracture Malunion, Bone

Outcome Measures

Primary Outcomes (3)

• Reduction accuracy

  Reproducibility of the reduction shape will be measured.

  1month after the surgery

• Implant placement

  Reproducibility of the implant placement will be evaluated.

  1month after the surgery

• Implant choices

  Reproducibility of the implant choices will be evaluated.

  1month after the surgery

Study Arms (2)

Image fusion group (Image fusion)

ACTIVE COMPARATOR

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

Device: Image fusion system

Control group (ZedTrauma)

NO INTERVENTION

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

Interventions

Image fusion system DEVICE

Image fusion system for the 3D preoperative planning

Image fusion group (Image fusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fracture paitents need osteosynthesis

You may not qualify if:

• Fracture patients under 18 years old

Sponsors & Collaborators

• Tokyo Medical University: lead

Study Sites (1)

Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, 300-0395, Japan

RECRUITING

Related Publications (2)

• 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.

  PMID: 34193171 DERIVED

• 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.

  PMID: 31694677 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Fractures, Malunited

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Yuichi M Yoshii

CONTACT

81298871161; yy12721@yahoo.co.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopaedic Surgery

Model Details: Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: May 21, 2018
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)