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) ]

Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (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) ]

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.


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