Clinical trial NCT06686017: Virtuos Bone Graft in Lumbar Fusion
Official title: A Prospective Post-Market Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Keywords: Lumbar spinal fusion
Cellular based allograft
Anterior lumbar interbody fusion (ALIF)
Lateral lumbar interbody fusion (LLIF)
Lead sponsor: Orthofix Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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).

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

Primary outcomes:
measure: Fusion
timeFrame: 12-months
Secondary outcomes:
measure: Disability (ODI)
timeFrame: 12 months
measure: Pain (NPRS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Myrtle Beach
country: United States
facility: OrthoSC
state: South Carolina
Study officials:
References: