Long-term Clinical Follow-up Analysis of Patients With Lu... | NCT06933004

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

NCT06933004

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Apr 17, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Lumbar Disease

Interventions

Posterior Spinal Fixation System

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2025Estimated

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

Mar 31, 2028Estimated

First Submitted Date

Apr 10, 2025

First Submission Date that Met QC Criteria

Apr 10, 2025

First Posted Date

Apr 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2025

Last Update Posted Date

Apr 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group			Device: Posterior Spinal Fixation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Posterior Spinal Fixation System	Device	Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.	Study Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

National Taiwan University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Xiao Furen	Contact	+886 2-23123456	63110	fxiao@ntu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100225	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided