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

NCT06933004 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

  • Lumbar Disease

Interventions

DEVICE

Posterior Spinal Fixation System

Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933004 on ClinicalTrials.gov