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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06933004

Enrollment

120

Registered

2025-04-17

Start date

2025-05-31

Completion date

2028-03-31

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disease

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.

Interventions

DEVICEPosterior Spinal Fixation System

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Visual Analog Scale (VAS)	Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.

Secondary

Measure	Time frame
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.

Countries

Taiwan

Contacts

Primary ContactDr. Xiao Furen

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026