Degenerative Disc Disease
Conditions
Keywords
Lumbar Fusion, Cellular Based Lyograft, TLIF
Brief summary
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos 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.
Detailed description
The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or open) with either Virtuos bone graft or autograft/allograft bone graft. Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos 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.
Interventions
DEVICEVirtuos
Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.
Sponsors
Orthofix Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 Enrollment: Virtuos vs. Autograft
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: 1. At least 18 years of age at the time of surgery 2. Undergoing lumbar spine fusion surgery with one of the following bone grafting options: 1. Virtuos 2. Virtuos with Autograft (local bone) 3. Autograft 4. Autograft + allograft (cancellous bone chips) 3. 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: 1. Instability as defined by \>3mm translation or \>5 degrees angulation 2. Osteophyte formation of facet joints or vertebral endplates 3. Decreased disc height, on average by \>2mm, but dependent upon the spinal level 4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule 5. Herniated nucleus pulposus 6. Facet joint degeneration/changes; and/or 7. Vacuum phenomenon 4. Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena: 1. Radiculopathy 2. Sensory deficit 3. Motor weakness 4. Reflex changes 5. Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1). 6. The number of levels decompressed must equal the number of levels fused. 7. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery. 8. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study 9. Subject must be willing and able to sign an informed consent document. 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Fusion | Twelve months | Fusion status at Twelve months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | Twelve months | Patient Reported Outcomes (PROM): Disability and Pain |
| Safety Profile | Twelve and Twenty-four months | Incidence of Adverse Events and Serious Adverse Events through Twelve and Twenty-four months. |
Countries
United States
Outcome results
None listed