NCT04848376

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: A-Spine Asia Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disc Disease
• Kyphosis
• Scoliosis
• Trauma
• Tumor
• Stenosis
• Pseudoarthrosis of Spine
• Deformity

Interventions

Type	Name	Description
DEVICE	(1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L	As long as there are patients using the above device, conduct questionnaire interview.

Timeline

• Start date: 2019-09-09
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2021-04-19
• Last updated: 2021-04-19

Locations

1 site across 1 country: Taiwan