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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (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 | As long as there are patients using the above device, conduct questionnaire interview. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The patients have implanted an A-SPINE device to stabilize the spine and/or restore the height of disc.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Ting LIU, MS | Contact | +886-2-29267088 | 621 | charlotte@aspine.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Bryan Huang, MD | Taichung Tzu Chi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Tzu Chi Hospital | Recruiting | Taichung | 427213 | Taiwan |
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| 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 |
| 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 |
| Fusion Rate | Use X-ray or CT to detect the spine fusion. | Baseline, 6 months,12 months, 24 months |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007738 | Kyphosis |
| D012600 | Scoliosis |
| D014947 | Wounds and Injuries |
| D009369 | Neoplasms |
| D003251 | Constriction, Pathologic |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013121 | Spinal Curvatures |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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