UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037570 |
|---|---|
| Receipt number | 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 | 2021/02/01 16:51:20 |
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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
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
hoki@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Department of Orthopaedics and Rehabilitation medicine Faculty of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
