Assessment of nanOss Bioactive 3D in the Posterolateral Spine

Exclusion Criteria

• •Symptomatic at more than two levels.
• •Has had previous fusion surgery at the level(s) to be treated (previous discectomy, laminotomy, laminectomy or nucleolysis at the level(s) to be treated \< 6 months ago is ok).
• •Has \> 11 degrees lumbar scoliosis.
• •Has \> 40 BMI.
• •Has \> Grade 1 spondylolisthesis.
• •Has osteoporosis (T-score of -2.5 or below), osteomalacia, Paget's disease or metabolic bone disease.
• •Has a disease that significantly inhibits bone healing (e.g., diabetes type 1, renal failure, impaired calcium metabolism).
• •Has a medical condition that requires or has a history of chronic steroid use (i.e., oral steroids), with the exception of inhaled/nasal corticosteroids steroids or has any medical condition that requires treatment with drugs known to interfere with bone healing.
• •Has a neurological disease (e.g., Parkinson's disease), a psychosocial disorder (e.g., suicidal, diminished capacity) or has a history of substance abuse which would preclude accurate evaluation or limit the ability to comply with study requirements.
• •Has either an active infection or infection at the site of surgery
• •Has a systemic disease (e.g., AIDS, HIV, active hepatitis, tuberculosis)
• •Has rheumatoid arthritis or other autoimmune disease.
• •Has spinal tumors.
• •Has an active malignancy (except non-melanoma skin cancer) or history of any invasive malignancy unless treated and in remission for at least five years.
• •Has a known sensitivity or allergies to porcine collagen, PEEK, tantalum or titanium.
• •Has active arachnoiditis.
• •Has fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
• •Is a prisoner.
• •Is involved in spinal litigation at the treated level(s).
• •Is participating in another clinical study that would confound Study data.
• •Is pregnant or is interested in becoming pregnant while participating in the Study.