Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine

Exclusion Criteria

• •symptomatic at more than 2 levels.
• •previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level \> 6 months is permitted).
• •more than 50% spondylolisthesis.
• •lumbar scoliosis greater than 11 degrees.
• •osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease.
• •spinal tumors.
• •active arachnoiditis.
• •fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
• •impaired calcium metabolism.
• •active infection or surgical site infection.
• •rheumatoid arthritis or other autoimmune disease
• •chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
• •systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
• •morbid obesity defined as body mass index (BMI)\>40 or a weight more than 100lbs over ideal body weight.
• •smokers unless the patient agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
• •psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse.
• •active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
• •documented allergies to porcine collagen or titanium
• •pregnancy, or interested in becoming pregnant in the next four years.
• •participation in another investigational study within 30 days.