Virtuos Bone Graft in Lumbar Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Post-Market Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion
Overview
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
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).
Primary outcome measures
- Fusion [Time frame: 12-months]
Secondary outcome measures (2)
- Disability (ODI) [Time frame: 12 months]
- Pain (NPRS) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- South Bend Orthopaedics — South Bend
- Michigan Orthopedic Surgeons — Southfield
- Northern Rockies Orthopaedics — Missoula
- Pinehurst Surgical Clinic — Pinehurst
- OrthoSC — Myrtle Beach
- Lowcountry Orthopaedics and Sports Medicine — North Charleston
- South Carolina Sports Medicine — North Charleston
- UT Southwestern Medical Center — Frisco
- … and 1 more center
Identifiers
NCT: NCT06686017 · CIP-VBG-24