Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™

Study Overview
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Brief Summary
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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®.

Official Title
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Evaluation of Bone Union Following Anterior Cervical Fusion Using a Bioactive Glass-Ceramic Spacer (NovoMax™): Comparison With a PEEK Cage Filled With β-Tricalcium Phosphate (Cervios ChronOs™)

Conditions
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Intervertebral Disk Degeneration, Intervertebral Disk Displacement

Intervention / Treatment
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* Device: Cervios ChronOs
* Device: NovoMax™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient who is expected to receive anterior cervical discectomy and fusion operation. Volunteer for this study with written consent. Exclusion Criteria: Patient with cervical spine fracture, infection and malignant tumor Below -3.5 T-score by DEXA bone densitometry Patient who is not suitable for this study judged by principal investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervios ChronOs<br>The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. | Device: Cervios ChronOs<br>* The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.<br>|
| Experimental: NovoMax™<br>The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer | Device: NovoMax™<br>* The ACDF surgery will be carried out with NovoMax™ after randomization procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior cervical discectomy and fusion, NovoMax, Bioactive Glass-ceramic Intervertebral Spacer