UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058431 |
|---|---|
| Receipt number | R000066808 |
| Scientific Title | Clinical recarch of 3D-printed Spinal Orthoses for practical use |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/14 12:34:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical recarch of 3D-printed Spinal Orthoses for practical use
Acronym
Clinical recarch of 3D-printed Spinal Orthoses
Scientific Title
Clinical recarch of 3D-printed Spinal Orthoses for practical use
Scientific Title:Acronym
Clinical recarch of 3D-printed Spinal Orthoses
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, the development of 3D printers has led to their use in the fabrication of spinal orthoses prescribed for the treatment of patients with spinal disorders. Because 3D printers can rapidly fabricate prostheteses and orthoses, it is expected that they will improve the effectiveness of treatment, shorten hospital stays, and reduce medical costs.However, spinal orthoses fabricated with 3D printers (hereinafter referred to as 3D-printed spinal orthoses) have not been shown to have the same strength, durability, wearability, and safety in terms of their effects on the skin as spinal orthoses fabricated using conventional methods (hereinafter referred to as conventional spinal orthoses).Therefore, the purpose of this study is to produce 3D-printed spinal orthoses for five healthy adults and verify them.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 3D printed spinal orthoses were worn by the subjects for three hours per day for three months, and evaluated weekly using a five-point face scale for the following evaluation items: 1) strength and durability (damage status), 2) comfort, 3) effect on skin, and 4) stainability.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wear for 9 months. Wear for 3 hours per day.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Being healthy
Key exclusion criteria
If you experience pain when wearing the Orthosis
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | YUKIO |
| Middle name | |
| Last name | AGARIE |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics & Orthotics and Assistive Technology, Faculty of Reahbilitation
Zip code
9503198
Address
1398 Shimami-cho, kitaku, Niigata-cty, Niigata
TEL
0252574576
agarie@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | YUKIO |
| Middle name | |
| Last name | AGARIE |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics & Orthotics and Assistive Technology, Faculty of Reahbilitation
Zip code
9503198
Address
1398 Shimami-cho, kitaku, Niigata-cty, Niigata
TEL
0252574576
Homepage URL
agarie@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
YUKIO AGARIE
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, kitaku, Niigata-cty, Niigata
Tel
0252574576
agarie@nuhw.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
新潟県
Institutions
Institutions
新潟医療福祉大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066808
