UMIN-CTR Clinical Trial

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	2022 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	2021 Year 02 Month 01 Day

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