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

Not Applicable

Completed

• Conditions: Intervertebral Disk Degeneration; Intervertebral Disk Displacement
• Interventions: Device: Cervios ChronOs; Device: NovoMax™

• Registration Number: NCT02425514
• Lead Sponsor: BioAlpha Inc.

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Study Start: 2015-05-21
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervios ChronOs	Cervios ChronOs	The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
NovoMax™	NovoMax™	The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer

Primary Outcome Measures

Name	Time	Method
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)	at 6 months after surgery (ACDF)	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

Name	Time	Method
VAS of Neck Pain(Post operative 6 Months)	at 6 months after surgery (ACDF)	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of