Status:
UNKNOWN
Post-Market Clinical Follow-up Study of A-SPINE's Products
Lead Sponsor:
A-Spine Asia Co., Ltd.
Conditions:
Degenerative Disc Disease
Kyphosis
Eligibility:
All Genders
20-80 years
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 clinica...
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 ...
Eligibility Criteria
Inclusion
- Subject is above 20 years of age;
- Subject is indicated for A-SPINE Spinal Fixation System;
- Subject is willing and able to provide informed consent to participate in the study;
- Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits.
Exclusion
- Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion Criteria.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 8 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04848376
Start Date
September 9 2019
End Date
September 8 2022
Last Update
April 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Taichung Tzu Chi Hospital
Taichung, Taiwan, 427213