Health TrialsbyHealthPanel

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

ConditionLumbar Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Individuals with impaired decision-making capacity or from vulnerable populations.

Individuals who are unable or unwilling to return for follow-up assessments.

Trial population

National Taiwan University Hospital

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Posterior Spinal Fixation System

    Device

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Study Group1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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