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

Intervertebral Disk Displacement Clinical Trial

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™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425514
• Other study ID #: BA04-CP11
• Status: Completed
• Phase: N/A
• Start date: May 21, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: January 2019
• Source: BioAlpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Intervertebral Disk Degeneration
• Intervertebral Disk Displacement

Intervention

Device:
• Cervios ChronOs
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
• NovoMax™
The ACDF surgery will be carried out with NovoMax™ after randomization procedure.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
BioAlpha Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)