Post-Market Clinical Follow-up Study of A-SPINE's Products
- Conditions
- KyphosisTraumaScoliosisDegenerative Disc DiseaseDeformityTumorStenosisPseudoarthrosis of Spine
- Interventions
- 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
- Registration Number
- NCT04848376
- Lead Sponsor
- A-Spine Asia Co., Ltd.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spine surgery (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 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
- Primary Outcome Measures
Name Time Method Visual Analogue Scale- Change from baseline at 2 year 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.
- Secondary Outcome Measures
Name Time Method Number of Device-related Adverse Events 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.
Oswestry Disability Index 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.
Fusion Rate Baseline, 6 months,12 months, 24 months Use X-ray or CT to detect the spine fusion.
Neck Disability Index 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.
Trial Locations
- Locations (1)
Taichung Tzu Chi Hospital
🇨🇳Taichung, Taiwan