Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn) — VCBM/ACDF  

Cervical Disc Degenerative Disorder Clinical Trial

Official title: Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.

Clinical Trial Description

This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure. ;

Related Conditions & MeSH terms

• Cervical Disc Degenerative Disorder
• Intervertebral Disc Degeneration

• NCT number: NCT02182843
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: January 2018