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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040998
Receipt No. R000046813
Scientific Title Development and clinical application of next-generation navigation system in osteosynthesis and osteotomy
Date of disclosure of the study information 2020/07/04
Last modified on 2021/07/07

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Basic information
Public title Development and clinical application of next-generation navigation system in osteosynthesis and osteotomy
Acronym Next-generation navigation system for osteosynthesis and osteotomy
Scientific Title Development and clinical application of next-generation navigation system in osteosynthesis and osteotomy
Scientific Title:Acronym Next-generation navigation system for osteosynthesis and osteotomy
Region
Japan

Condition
Condition Fracture, fracture malunion
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a three-dimensional bone morphology and position estimation system for based on X-ray fluoroscopic images, and a real-time registration system with a 3D preoperative planning image to help osteosynthesis and osteotomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Image evaluations before and after surgery
Key secondary outcomes Clinical evaluations before and after surgery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Osteosynthesis and osteotomy using navigation system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients indicated for osteosynthesis and osteotomy
Key exclusion criteria Patients with a pathological fractures, deformity of the same bone that may affect the performance of surgery, fractures, osteomyelitis, or patients who are unable to express their intentions due to consciousness disorder, etc.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yuichi
Middle name
Last name Yoshii
Organization Tokyo Medical University Ibaraki Medical Center
Division name Orthopaedic surgery
Zip code 300-0395
Address 3-20-1 Chuo, Ami, Inashiki, Ibaraki, Japan
TEL 0298871161
Email yyoshii@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Yoshii
Organization Tokyo Medical University Ibaraki Medical Center
Division name Orthopaedic surgery
Zip code 300-0395
Address 3-20-1 Chuo, Ami, Inashiki, Ibaraki, Japan
TEL 029-887-1161
Homepage URL
Email yyoshii@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization AMED, Japan Society for the promotion of science, Terumo, JA
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical University
Address 6-7-1, Nishishinjuku, Shinjuku, Tokyo, Japan
Tel 03-3342-6111
Email adm_irb@tokyo-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Reproducibility evaluation of 3D preoperative planning based on 3D reference points.
Established a method to evaluate the 3D reproducibility of 3D preoperative planning in osteosynthesis using a measurement index based on the 3D reference point of the fractured part. The reproducibility of the 3D preoperative plan for distal radius fracture osteosynthesis was clinically evaluated. As a result, it was found that each reference point can be reproduced with an error of 1.9-2.2 mm.
Results date posted
2021 Year 07 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Distal radius fracture patients
Participant flow Visit hospital
Adverse events No
Outcome measures Reproducibility of reference poiunts
Plan to share IPD N/A
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 17 Day
Date of IRB
2020 Year 01 Month 23 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 04 Day
Last modified on
2021 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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