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Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
Sponsor: National Taiwan University Hospital
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.
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-05
Completion Date
2028-03-31
Last Updated
2025-04-17
Healthy Volunteers
No
Conditions
Interventions
Posterior Spinal Fixation System
Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan