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ViBone in Cervical and Lumbar Spine Fusion

Degenerative Disc Disease Clinical Trial

Official title:
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion

Clinical Trial Summary

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Clinical Trial Description

This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for up to 50 subjects undergoing ACDF surgery and up to 50 subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03425682
Study type Observational
Source Aziyo Biologics, Inc.
Contact
Status Completed
Phase
Start date May 14, 2018
Completion date June 30, 2021
View Details
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