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

April 10, 2025 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Xiao Furen
  • Phone Number: 63110 +886 2-23123456
  • Email: fxiao@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

National Taiwan University Hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Device: Posterior Spinal Fixation System
Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
Fusion Rate
Time Frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 202402029DIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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