Lumbar DiseaseNCT06933004
Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
An observational study of Lumbar Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lumbar Disease
- What is being tested?
- Posterior Spinal Fixation System
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: National Taiwan University Hospital
Who may be able to join
- 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.
Who cannot join
- Individuals with impaired decision-making capacity or from vulnerable populations.
- Individuals who are unable or unwilling to return for follow-up assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Dr. Xiao Furen, +886 2-23123456 ext. 63110, fxiao@ntu.edu.tw
About this study
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.
- Conditions
- Lumbar Disease
- Being tested
- Posterior Spinal Fixation System
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Spinal Fixation SystemDevice
Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described Receives: Device: Posterior Spinal Fixation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Measured: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
Secondary outcomes (2)
Oswestry Disability Index (ODI)
Measured: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
Fusion Rate
Measured: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study startMay 2025 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933004
- Sponsor's protocol ID
- 202402029DIND
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
- ClinicalTrials.gov ID
- NCT06933004
- Acronym / sponsor ID
- 202402029DIND
- Conditions
- Lumbar Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Posterior Spinal Fixation System |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- National Taiwan University Hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with impaired decision-making capacity or from vulnerable populations.
- Individuals who are unable or unwilling to return for follow-up assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Spinal Fixation SystemUsing spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System. | Device | Study Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.
2 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Lumbar Disease
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Xiao Furen (+886 2-23123456 ext. 63110, fxiao@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.