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NCT Number: NCT06933004

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

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.

Recruiting

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Key information

Conditions

Lumbar Disease Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location status: Recruiting

Location contact

Dr. Xiao Furen

CONTACT

[email protected]

+886 2-23123456 ext. 63110

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Posterior Spinal Fixation System

Device

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

Primary outcomes

  1. Visual Analog Scale (VAS)

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

Secondary outcomes

  1. Oswestry Disability Index (ODI)

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

  2. Fusion Rate

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Xiao Furen

CONTACT

[email protected]

+886 2-23123456 ext. 63110

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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