Clinical Trial

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

Recruiting
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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.
Trial Details
NCT Number NCT06933004
Lead Sponsor National Taiwan University Hospital
Conditions Lumbar Disease
Enrollment 120 participants
Start Date 2025-05
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-17