Spots Global Cancer Trial Database for Post-Market Clinical Follow-up Study of A-SPINE's Products
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Trial Identification
Brief Title: Post-Market Clinical Follow-up Study of A-SPINE's Products
Official Title: Post-Market Clinical Follow-up Study of A-SPINE's Products
Study ID: NCT04848376
Study Description
Brief Summary: This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.
Detailed Description: The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Taichung Tzu Chi Hospital, Taichung, , Taiwan
Contact Details
Name: Bryan Huang, MD
Affiliation: Taichung Tzu Chi Hospital
Role: PRINCIPAL_INVESTIGATOR
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