Clinical Trial: Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official 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 ChronO
Brief 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®.
Detailed Summary:
Sponsor: BioAlpha Inc.
Current Primary Outcome: Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months) [ Time Frame: at 6 months after surgery (ACDF) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: VAS of Neck Pain(Post operative 6 Months) [ Time Frame: at 6 months after surgery (ACDF) ]
Original Secondary Outcome: Same as current
Information By: BioAlpha Inc.
Dates:
Date Received: April 21, 2015
Date Started: May 2015
Date Completion:
Last Updated: April 23, 2015
Last Verified: April 2015