Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
NCT ID: NCT06933004
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-05-31
2028-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Study Group
Posterior Spinal Fixation System
Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.
Interventions
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Posterior Spinal Fixation System
Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.
Eligibility Criteria
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Inclusion Criteria
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
2. Individuals who are unable or unwilling to return for follow-up assessments.
20 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202402029DIND
Identifier Type: -
Identifier Source: org_study_id
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