Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System

Exclusion Criteria

• •Previous spine surgery at the index level
• •Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
• •Active systemic infection or infection at the operative site
• •Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
• •Metabolic bone disease such as osteoporosis and osteopenia that contradicts spinal surgery
• •History of an osteoporotic fracture
• •History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
• •Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
• •Known allergy to titanium or cobalt chrome
• •Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia
• •Insulin-dependent type 1 or type 2 diabetes
• •Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
• •Pregnant, or intends to become pregnant, during the course of the study
• •Severe obesity (Body Mass Index \> 40)
• •Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.
• •Involved in current or pending spinal litigation where permanent disability benefits are being sought
• •Incarcerated at the time of study enrollment
• •Current participation in an investigational study that may impact study outcomes