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

National Taiwan University

Status: Enrolling

Conditions: Lumbar Disease

Treatments: Device: Posterior Spinal Fixation System

Study type: Observational

Funder types: Other

Identifiers

NCT06933004

202402029DIND

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

120 participants in 1 patient group

Study Group

Treatment:

Device: Posterior Spinal Fixation System