Post-Market Clinical Follow-up Study of A-SPINE's Products
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deformity
- Degenerative Disc Disease
- Kyphosis
- Pseudoarthrosis of Spine
- Scoliosis
- Stenosis
- Trauma
- Tumor
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
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 clini...
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.
Tracking Information
- NCT #
- NCT04848376
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bryan Huang, MD Taichung Tzu Chi Hospital
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