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

NCT06933004 | Recruiting

• 1 other identifier: 202402029DIND
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disease

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.

Secondary Outcomes (2)

• Oswestry Disability Index (ODI)

  Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.

• Fusion Rate

  Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.

Study Arms (1)

Study Group

Device: Posterior Spinal Fixation System

Interventions

Posterior Spinal Fixation System DEVICE

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

Study Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

National Taiwan University Hospital

You may qualify if:

• 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 may not qualify if:

• Individuals with impaired decision-making capacity or from vulnerable populations.
• Individuals who are unable or unwilling to return for follow-up assessments.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Xiao Furen

CONTACT

+886 2-23123456; fxiao@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)