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

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Virtuos

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Britain, Connecticut, United States, 06051
      • Central CT Neurosurgery & Spine
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Michigan Brain and Spine
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas South Western

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria:

  1. At least 18 years of age at the time of surgery

  2. Undergoing lumbar spine fusion surgery with one of the following bone grafting options:

     1. Virtuos
     2. Virtuos with Autograft (local bone)
     3. Autograft
     4. Autograft + allograft (cancellous bone chips)

  3. Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:

     1. Instability as defined by >3mm translation or >5 degrees angulation
     2. Osteophyte formation of facet joints or vertebral endplates
     3. Decreased disc height, on average by >2mm, but dependent upon the spinal level
     4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
     5. Herniated nucleus pulposus
     6. Facet joint degeneration/changes; and/or
     7. Vacuum phenomenon

  4. Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena:

     1. Radiculopathy
     2. Sensory deficit
     3. Motor weakness
     4. Reflex changes
  5. Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1).
  6. The number of levels decompressed must equal the number of levels fused.
  7. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.
  8. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study
  9. Subject must be willing and able to sign an informed consent document.

  10. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.

      Exclusion Criteria:

Exclusion criteria:

1. Subject is under 18 years of age (<18) at the time of consent
2. Subject has had prior lumbar spine fusion surgery at any level
3. Subject has greater than grade 1 spondylolisthesis of the lumbar spine
4. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)
5. Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
6. Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autograft; Autograft +/- Allograft Chips	Device: Virtuos; Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.; Other Names: Autograft
Experimental: Virtuos; Virtuos +/- Local Bone	Device: Virtuos; Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.; Other Names: Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Fusion	Fusion status at Twelve months postoperative	Twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes	Patient Reported Outcomes (PROM): Disability and Pain	Twelve months
Safety Profile	Incidence of Adverse Events and Serious Adverse Events through Twelve and Twenty-four months.	Twelve and Twenty-four months

Collaborators and Investigators

• Sponsor: Orthofix Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: TLIF; Lumbar Fusion; Cellular Based Lyograft
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration; Surgical Procedures, Operative; Transplantation; Transplantation, Autologous
• Other Study ID Numbers: CP - 2201VLF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes