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

BioAlpha

Status: Completed

Conditions: Intervertebral Disk Degeneration; Intervertebral Disk Displacement

Treatments: Device: NovoMax™; Device: Cervios ChronOs

Study type: Interventional

Funder types: Industry

Identifiers

NCT02425514

BA04-CP11

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.

Enrollment: 76 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Cervios ChronOs

Experimental group

Description:

The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.

Treatment:

Device: Cervios ChronOs

NovoMax™

Experimental group

Description:

The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer

Treatment:

Device: NovoMax™