Clinical Trials in the USA / NCT06686017
Enrolling by invitation
Observational
Virtuos Bone Graft in Lumbar Fusion
NCT06686017 · tracked via the Priya Life Science USA tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Orthofix Inc. trials in the USA
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Active, not recruiting
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
Active, not recruiting
Orthofix PhysioStim PEMF Ankle Fusion Retrospective
Active, not recruiting
Other trials for the same condition
OssDsign® Spine Registry Study ("Propel")
Recruiting
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
Active, not recruiting
Cervical Interbody Implant Study
Enrolling by invitation
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
Active, not recruiting
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Enrolling by invitation
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