Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058431) titled 'Clinical recarch of 3D-printed Spinal Orthoses for practical use' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - Healthy people
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Wear for 9 months. Wear for 3 hours per day.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male
Key inclusion criteria - Being healthy
Key exclusion criteria - If you experience pain when wearing the Orthosis
Target Size - 5
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 01 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066808
Disclaimer: Curated by HT Syndication.
