Post-Market Clinical Follow-up Study of A-SPINE's Products

April 14, 2021 updated by: A-Spine Asia Co., Ltd.
This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 427213
        • Recruiting
        • Taichung Tzu Chi Hospital
        • Contact:
          • Bryan Huang, MD
          • Phone Number: 3129 +886-4-36060666
        • Principal Investigator:
          • Bryan Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients have implanted an A-SPINE device to stabilize the spine and/or restore the height of disc.

Description

Inclusion Criteria:

  • Subject is above 20 years of age;
  • Subject is indicated for A-SPINE Spinal Fixation System;
  • Subject is willing and able to provide informed consent to participate in the study;
  • Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits.

Exclusion Criteria:

  • Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion Criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spine surgery

Use these system:

(1) SmartLoc (2) SmartLoc Evo(3) Winloc (4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L
Device: (1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L
As long as there are patients using the above device, conduct questionnaire interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale- Change from baseline at 2 year
Time Frame: Change from baseline at 2 year
Visual Analogue Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain. Compare baseline and postoperative improvement VAS scores.
Change from baseline at 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: Baseline, 6 months, 12 months, 24 months
The NDI is a questionnaire that is commonly used in clinical trials to measure the self-reported functional status of patients with neck pain.The ten questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). Compare baseline and postoperative improvement NDI scores.
Baseline, 6 months, 12 months, 24 months
Oswestry Disability Index
Time Frame: Baseline, 6 months,12 months, 24 months
The ODI is a questionnaire that is commonly used in clinical trials to measure the self-reported functional status of patients with neck pain.The ten questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). Compare baseline and postoperative improvement ODI scores.
Baseline, 6 months,12 months, 24 months
Number of Device-related Adverse Events
Time Frame: Baseline, 6 months,12 months, 24 months
Adverse events associated with the device will be assessed at each follow-up visit and the number of cases at the 2-year follow-up will be counted.
Baseline, 6 months,12 months, 24 months
Fusion Rate
Time Frame: Baseline, 6 months,12 months, 24 months
Use X-ray or CT to detect the spine fusion.
Baseline, 6 months,12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A-Spine Asia Co., Ltd.

Investigators

  • Principal Investigator: Bryan Huang, MD, Taichung Tzu Chi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Anticipated)

September 8, 2022

Study Completion (Anticipated)

September 8, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC108-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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