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

Status Recruiting

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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