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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848376
• Other study ID #: REC108-16
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Deformity
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Kyphosis
• Pseudarthrosis
• Pseudoarthrosis of Spine
• Scoliosis
• Stenosis
• Trauma
• Tumor

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