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Completed

NCT Number: NCT02425514

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

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

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Key information

Conditions

Intervertebral Disk Degeneration Bone Diseases Hernia Intervertebral Disc Degeneration Intervertebral Disc Displacement Intervertebral Disk Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervios ChronOs

Device

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

NovoMax™

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

BioAlpha Inc.

Industry

Registry information

Official study title

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™)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2015
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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