NCT05614284

Comparative Analysis of Virtuos and Autograft in Lumbar Fusion

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos 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.

Detailed 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 Virtuos bone graft or autograft/allograft bone graft. Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos 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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Virtuos	Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.

Timeline

• Start date: 2022-11-14
• Primary completion: 2024-05-16
• Completion: 2024-05-16
• First posted: 2022-11-14
• Last updated: 2025-11-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study