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The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervios ChronOs | Experimental | The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. |
|
| NovoMax™ | Experimental | The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervios ChronOs | Device | The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months) | Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF). | at 6 months after surgery (ACDF) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS of Neck Pain(Post operative 6 Months) | Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF). Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right. | at 6 months after surgery (ACDF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Sup Yeom, MD. Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
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| NovoMax™ | Device | The ACDF surgery will be carried out with NovoMax™ after randomization procedure. |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |