Ireland
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Enrolling by invitation Observational

Virtuos Bone Graft in Lumbar Fusion

NCT06686017 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-06-05
Last updated
2025-11-28

Condition(s) studied

Degenerative Disc Disease

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Fusion — 12-months
    Fusion of the spinal motion segments

Trial sites (9)

FacilityCityRegionStatus
South Bend Orthopaedics South Bend Indiana
Michigan Orthopedic Surgeons Southfield Michigan
Northern Rockies Orthopaedics Missoula Montana
Pinehurst Surgical Clinic Pinehurst North Carolina
OrthoSC Myrtle Beach South Carolina
Lowcountry Orthopaedics and Sports Medicine North Charleston South Carolina
South Carolina Sports Medicine North Charleston South Carolina
UT Southwestern Medical Center Frisco Texas
Tuckahoe Orthopaedics Richmond Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06686017 on ClinicalTrials.gov ↗ ← All trials in the USA