Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posterior Spinal Fixation System.
- Who it may be relevant to
- Registry conditions: Lumbar Disease. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Posterior Spinal Fixation System
Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.
Primary outcome measures
- Visual Analog Scale (VAS) [Time frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.]
Secondary outcome measures (2)
- Oswestry Disability Index (ODI) [Time frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.]
- Fusion Rate [Time frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.]
Eligibility criteria
Inclusion criteria
- Aged between 20 and 80 years.
- Patients with lumbar spine disorders requiring surgical treatment.
- Able to understand the study content after explanation, capable of expressing their experiences, and willing to sign the written informed consent form.
Exclusion criteria
- Individuals with impaired decision-making capacity or from vulnerable populations.
- Individuals who are unable or unwilling to return for follow-up assessments.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06933004 · 202402029DIND