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

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™)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02425514

Enrollment

Registered

2015-04-24

Start date

2015-05-21

Completion date

2017-02-01

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervertebral Disk Degeneration, Intervertebral Disk Displacement

Keywords

Anterior cervical discectomy and fusion, NovoMax, Bioactive Glass-ceramic Intervertebral Spacer

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®.

Interventions

DEVICECervios ChronOs

The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.

DEVICENovoMax™

The ACDF surgery will be carried out with NovoMax™ after randomization procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026