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

NCT ID: NCT02425514

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-21

Study Completion Date

2017-02-01

Brief Summary

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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

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Conditions

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Intervertebral Disk Degeneration Intervertebral Disk Displacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cervios ChronOs

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

Group Type EXPERIMENTAL

Cervios ChronOs

Intervention Type DEVICE

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

NovoMax™

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

Group Type EXPERIMENTAL

NovoMax™

Intervention Type DEVICE

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

Interventions

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Cervios ChronOs

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

Intervention Type DEVICE

NovoMax™

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAlpha Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin Sup Yeom, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BA04-CP11

Identifier Type: -

Identifier Source: org_study_id

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