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Comparative Analysis of Virtuous and Autograft in Lumbar Fusion

Degenerative Disc Disease Clinical Trial

Official title:
A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuous and Autograft Bone Graft in Lumbar Fusion Surgery

Clinical Trial Summary

Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.

Clinical Trial Description

The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or open) with either Virtuous bone graft or autograft/allograft bone graft. Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05614284
Study type Interventional
Source Orthofix Inc.
Contact Christopher Gunter, MPH
Phone 9015962386
Email chrisgunter@orthofix.com
Status Recruiting
Phase N/A
Start date January 3, 2023
Completion date December 2, 2025
View Details
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