Clinical trial · Observational
Post-Market Clinical Follow-up Study of A-SPINE's Products
NCT04848376CI-TRIAL-00051336unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deformity | — | UNRESOLVED | — |
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Kyphosis | — | UNRESOLVED | — |
| Pseudoarthrosis of Spine | — | UNRESOLVED | — |
| Scoliosis | — | UNRESOLVED | — |
| Stenosis | — | UNRESOLVED | — |
| Trauma | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Spine surgery
- description
- 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
- interventionNames
- 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
Primary outcomes (1)
- measure
- Visual Analogue Scale- Change from baseline at 2 year
- timeFrame
- Change from baseline at 2 year
- description
- 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 outcomes (4)
- measure
- Neck Disability Index
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.