NCT06933004 Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
| NCT ID | NCT06933004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Lumbar Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-05 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06933004 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Lumbar Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06933004 currently recruiting?
Yes, NCT06933004 is actively recruiting participants. Contact the research team at fxiao@ntu.edu.tw for enrollment information.
Where is the NCT06933004 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06933004 clinical trial?
NCT06933004 is sponsored by National Taiwan University Hospital. The trial plans to enroll 120 participants.