Virtuos Bone Graft in Lumbar Fusion

Orthofix

Status: Invitation-only

Conditions: Degenerative Disc Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT06686017

CIP-VBG-24

Details and patient eligibility

About

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

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Subjects with one or two level degenerative disc disease of the lumbar spine

Description:

There are no investigational interventions. Subjects will undergo a one or two level spinal fusion procedure per the attending physician/surgeon standard practice.