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

Recruitingn/aAges 20 Years - 80 YearsAllNational Taiwan University Hospital
NCT06933004 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged between 20 and 80 years. 2. Patients with lumbar spine disorders requiring surgical treatment. 3. Able to understand the study content after explanation, capable of expressing their experiences, and willing to sign the written informed consent form. Exclusion Criteria: 1. Individuals with impaired decision-making capacity or from vulnerable populations. 2. Individuals who are unable or unwilling to return for follow-up assessments.
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What it tests

  • Posterior Spinal Fixation System
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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