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

NCT ID: NCT06933004

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Posterior Spinal Fixation System

Intervention Type DEVICE

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

Interventions

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Posterior Spinal Fixation System

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Dr. Xiao Furen

Role: CONTACT

+886 2-23123456 ext. 63110

Facility Contacts

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Dr. Xiao Furen

Role: primary

+886 2-23123456 ext. 63110

Other Identifiers

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202402029DIND

Identifier Type: -

Identifier Source: org_study_id

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