Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
NCT ID: NCT02425514
Last Updated: 2019-01-04
Study Results
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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COMPLETED
NA
76 participants
INTERVENTIONAL
2015-05-21
2017-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Cervios ChronOs
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
NovoMax™
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.
NovoMax™
The ACDF surgery will be carried out with NovoMax™ after randomization procedure.
Eligibility Criteria
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Inclusion Criteria
* Volunteer for this study with written consent.
Exclusion Criteria
* Below -3.5 T-score by DEXA bone densitometry
* Patient who is not suitable for this study judged by principal investigator
20 Years
80 Years
ALL
No
Sponsors
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BioAlpha Inc.
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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BA04-CP11
Identifier Type: -
Identifier Source: org_study_id
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