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

January 3, 2019 updated by: BioAlpha Inc.

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™)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervios ChronOs
The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
Device: Cervios ChronOs
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
Experimental: NovoMax™
The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer
Device: NovoMax™
The ACDF surgery will be carried out with NovoMax™ after randomization procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
Time Frame: 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).
at 6 months after surgery (ACDF)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS of Neck Pain(Post operative 6 Months)
Time Frame: 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.
at 6 months after surgery (ACDF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAlpha Inc.

Investigators

  • Principal Investigator: Jin Sup Yeom, MD. Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA04-CP11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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