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

NCT02425514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-01-04

No results posted yet for this study

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®.

Conditions

  • Intervertebral Disk Degeneration
  • Intervertebral Disk Displacement

Interventions

DEVICE

Cervios ChronOs

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

DEVICE

NovoMax™

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

Sponsors & Collaborators

  • BioAlpha Inc.

    lead INDUSTRY

Principal Investigators

  • Jin Sup Yeom, MD. Ph.D. · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-21
Primary Completion
2017-02-01
Completion
2017-02-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425514 on ClinicalTrials.gov