NCT06933004

Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a long-term follow-up of postoperative clinical outcomes in patients with lumbar spine disorders, monitoring spine implants SmartMIS Spinal Fixation System and ASA Spinal Fixation System. Patients will be selected based on inclusion and exclusion criteria. The informed consent process will be initiated by the physician. A questionnaire-based survey will be conducted, which includes the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Fusion Rate. Subjects will complete the same questionnaire assessments preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively. The total number of subjects to be enrolled is 120. The total duration of the study is expected to be 4 years.

Conditions

• Lumbar Disease

Interventions

Type	Name	Description
DEVICE	Posterior Spinal Fixation System	Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: Taiwan