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Post-Market Clinical Follow-up Study of A-SPINE's Products

Trauma Clinical Trial

Official title:
Post-Market Clinical Follow-up Study of A-SPINE's Products

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04848376
Study type Observational
Source A-Spine Asia Co., Ltd.
Contact Shu-Ting LIU, MS
Phone +886-2-29267088
Email charlotte@aspine.com.tw
Status Recruiting
Phase
Start date September 9, 2019
Completion date September 8, 2022
View Details
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