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

A-Spine Asia Co., Ltd.200 enrolled

Overview

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.

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

200

Conditions

Degenerative Disc Disease Kyphosis Scoliosis Trauma Tumor Stenosis Pseudoarthrosis of Spine Deformity

Interventions

(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 LDEVICE

As long as there are patients using the above device, conduct questionnaire interview.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taichung Tzu Chi Hospital

Taichung, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline at 2 year

Secondary Outcomes

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.

Time frame: Baseline, 6 months, 12 months, 24 months

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.

Time frame: Baseline, 6 months,12 months, 24 months

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.

Time frame: Baseline, 6 months,12 months, 24 months

Fusion Rate

Use X-ray or CT to detect the spine fusion.

Time frame: Baseline, 6 months,12 months, 24 months

Central Contacts

Shu-Ting LIU, MS

CONTACT

+886-2-29267088 charlotte@aspine.com.tw

Data from ClinicalTrials.gov

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