Actively Recruiting
Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
Led by National Taiwan University Hospital · Updated on 2025-04-17
120
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Individuals with impaired decision-making capacity or from vulnerable populations.
- Individuals who are unable or unwilling to return for follow-up assessments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
Research Team
D
Dr. Xiao Furen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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