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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037570
Receipt No. R000042235
Scientific Title Fundamental study on custom implant for deformation disease on the hand and foot created by three-dimensional additive manufacturing
Date of disclosure of the study information 2019/08/01
Last modified on 2019/08/01

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Basic information
Public title Fundamental study on custom implant for deformation disease on the hand and foot created by three-dimensional additive manufacturing
Acronym Fundamental study on custom implant for deformation disease on the hand and foot created by three-dimensional additive manufacturing
Scientific Title Fundamental study on custom implant for deformation disease on the hand and foot created by three-dimensional additive manufacturing
Scientific Title:Acronym Fundamental study on custom implant for deformation disease on the hand and foot created by three-dimensional additive manufacturing
Region
Japan

Condition
Condition CM Arthrosis of Thumb
Hallux Valgus
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will verify whether the implant as designed can be created based on the DICOM data of CT using three-dimensional stacking technology. With regard to the CM CM custom-made spacer for the thumb, it is possible to move the joint passively and observe whether there is no dislocation or interference with the soft tissue easily, and the physical stability and mobility of the implant within the joint. The purpose is to clarify. With regard to custom-made plates for fixation of hallux valgus correction osteotomy, the purpose is to clarify the contact area with the base bed bone, stability of the bone base, and the difference in correction angle between the preoperative plan and the intraoperative period.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes There is no direct benefit for patients newly in this study, but there may be indirect benefits in the future.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Checking Fittings for Custom Made Implants
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Surgical indication for hallux valgus or thumb CM arthrosis
Key exclusion criteria Patients who have had a history of trauma or surgery on their feet or hands
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hisashi
Middle name
Last name Oki
Organization University of Fukui
Division name Department of Orthopaedics and Rehabilitation medicine Faculty of Medical Sciences
Zip code 910-1193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, JAPAN
TEL 0776-61-8383
Email hoki@u-fukui.ac.jp

Public contact
Name of contact person
1st name Hisashi
Middle name
Last name Oki
Organization University of Fukui
Division name Department of Orthopaedics and Rehabilitation medicine Faculty of Medical Sciences
Zip code 910-1193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, JAPAN
TEL 0776-61-8383
Homepage URL
Email hoki@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Department of Orthopaedics and Rehabilitation medicine Faculty of Medical Sciences
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Department of Orthopaedics and Rehabilitation medicine Faculty of Medical Sciences University of Fukui
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, JAPAN
Tel 0776-61-8383
Email hoki@u-fukui.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
2019 Year 08 Month 01 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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 04 Month 02 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2021 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
2019 Year 08 Month 01 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042235

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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