Back to resultsEvaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
Primary Purpose
Intervertebral Disk Degeneration, Intervertebral Disk Displacement
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cervios ChronOs
NovoMax™
Sponsored by
About this trial
This is an interventional treatment trial for Intervertebral Disk Degeneration focused on measuring Anterior cervical discectomy and fusion, NovoMax, Bioactive Glass-ceramic Intervertebral Spacer
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cervios ChronOs
NovoMax™
Arm Description
The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02425514
Brief Title
Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
Official Title
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™)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2015 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioAlpha Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disk Degeneration, Intervertebral Disk Displacement
Keywords
Anterior cervical discectomy and fusion, NovoMax, Bioactive Glass-ceramic Intervertebral Spacer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervios ChronOs
Arm Type
Experimental
Arm Description
The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
Arm Title
NovoMax™
Arm Type
Experimental
Arm Description
The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer
Intervention Type
Device
Intervention Name(s)
Cervios ChronOs
Intervention Description
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
Intervention Type
Device
Intervention Name(s)
NovoMax™
Intervention Description
The ACDF surgery will be carried out with NovoMax™ after randomization procedure.
Primary Outcome Measure Information:
Title
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
Description
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF).
Time Frame
at 6 months after surgery (ACDF)
Secondary Outcome Measure Information:
Title
VAS of Neck Pain(Post operative 6 Months)
Description
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.
Time Frame
at 6 months after surgery (ACDF)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Sup Yeom, MD. Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
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