Virtuos Bone Graft in Lumbar Fusion

NCT06686017 | Enrolling By Invitation

• 1 other identifier: CIP-VBG-24
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Degenerative Disc Disease

Keywords

Lumbar spinal fusion; Cellular based allograft; Anterior lumbar interbody fusion (ALIF); Lateral lumbar interbody fusion (LLIF); Virtuos

Outcome Measures

Primary Outcomes (1)

• Fusion

  Fusion of the spinal motion segments

  12-months

Secondary Outcomes (2)

• Disability (ODI)

  12 months

• Pain (NPRS)

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.-

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (9)

South Bend Orthopaedics

South Bend, Indiana, 46635, United States

Location

Michigan Orthopedic Surgeons

Southfield, Michigan, 48033, United States

Location

Northern Rockies Orthopaedics

Missoula, Montana, 59804, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

OrthoSC

Myrtle Beach, South Carolina, 29579, United States

Location

Lowcountry Orthopaedics and Sports Medicine

North Charleston, South Carolina, 29406, United States

Location

South Carolina Sports Medicine

North Charleston, South Carolina, 29406, United States

Location

UT Southwestern Medical Center

Frisco, Texas, 75033, United States

Location

Tuckahoe Orthopaedics

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: June 5, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (9)