Virtuos Bone Graft in Lumbar Fusion

Enrolling by invitation

Conditions studied: Degenerative Disc Disease

In brief

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

Key facts

Study ID

NCT06686017

Run by

Orthofix Inc.

People needed

150

Starts

2025-06-05

Expected to finish

2029-04-01

Last updated by the study team

2025-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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