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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04848376
Other study ID # REC108-16
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 9, 2019
Est. completion date September 8, 2022

Study information

Verified date April 2021
Source A-Spine Asia Co., Ltd.
Contact Shu-Ting LIU, MS
Phone +886-2-29267088
Email charlotte@aspine.com.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 8, 2022
Est. primary completion date September 8, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Taiwan Taichung Tzu Chi Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
A-Spine Asia Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale- 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 Neck Disability Index 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
Secondary Oswestry Disability Index 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
Secondary Number of Device-related Adverse Events 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
Secondary Fusion Rate Use X-ray or CT to detect the spine fusion. Baseline, 6 months,12 months, 24 months
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