Comparative Analysis of Virtuous and Autograft in Lumbar Fusion

Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.

Inclusion Criteria:Inclusion criteria:At least 18 years of age at the time of surgeryUndergoing lumbar spine fusion surgery with one of the following bone grafting options:VirtuousVirtuous with Autograft (local bone)AutograftAutograft + allograft (cancellous bone chips)Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:Instability as defined by >3mm translation or >5 degrees angulationOsteophyte formation of facet joints or vertebral endplatesDecreased disc height, on average by >2mm, but dependent upon the spinal levelScarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsuleHerniated nucleus pulposusFacet joint degeneration/changes; and/orVacuum phenomenonSubject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena:RadiculopathySensory deficitMotor weaknessReflex changesSubject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1).The number of levels decompressed must equal the number of levels fused.Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the studySubject 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 regimen.Exclusion Criteria:Exclusion criteria:Subject is under 18 years of age (<18) at the time of consentSubject has had prior lumbar spine fusion surgery at any levelSubject has greater than grade 1 spondylolisthesis of the lumbar spineSubject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesisSubject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection