Virtuos Bone Graft in Lumbar Fusion

A Prospective Post-Market Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion

A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease

Detailed Description

Single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (Virtuos) as the bone graft There is no experimental intervention for this study. Subjects will be treated per standard of care by their attending physician/surgeon. The primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using CT as the imaging modality. The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (Trinity Elite).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • Indiana
    • South Bend, Indiana, United States, 46635
      • South Bend Orthopaedics
  • Michigan
    • Southfield, Michigan, United States, 48033
      • Michigan Orthopedic Surgeons
  • Montana
    • Missoula, Montana, United States, 59804
      • Northern Rockies Orthopaedics
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Surgical Clinic
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29579
      • OrthoSC
    • North Charleston, South Carolina, United States, 29406
      • Lowcountry Orthopaedics and Sports Medicine
    • North Charleston, South Carolina, United States, 29406
      • South Carolina Sports Medicine
  • Texas
    • Frisco, Texas, United States, 75033
      • UT Southwestern Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Tuckahoe Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population are patients with degenerative disc disease of the lumbar spine at one or two levels who are considered to be candidates for spinal fusion surgery by their attending physician/surgeon.

Description

Inclusion Criteria:

Subject must be 18 years of age (≥ 18 years) or older at the time of consent.

• Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels.
• Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips.
• Subject must be willing and able to sign an informed consent document.
• 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 protocol.-

Exclusion Criteria:

• Subject is under 18 years of age (<18) at the time of consent.

  • Subject has had prior lumbar spine fusion surgery at any level.
  • Subject has greater than grade 1 spondylolisthesis of the lumbar spine. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)
  • 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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with one or two level degenerative disc disease of the lumbar spine; There are no investigational interventions. Subjects will undergo a one or two level spinal fusion procedure per the attending physician/surgeon standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	Fusion of the spinal motion segments	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability (ODI)	The ODI will be used to assess disability if the patient reported outcomes are routinely collected at participating centers.	12 months
Pain (NPRS)	A pain rating scale (VAS or NRS) will be used to assess pain levels at baseline and follow-up visits, if pain assessment is routinely collected as standard of care at participating sites. 0 will indicate no pain and 10 will indicate the highest amount of pain possible.	12 months

Collaborators and Investigators

• Sponsor: Orthofix Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

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: Lumbar spinal fusion; Cellular based allograft; Anterior lumbar interbody fusion (ALIF); Lateral lumbar interbody fusion (LLIF); Virtuos
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CIP-VBG-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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