INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine

Exclusion Criteria

• •Requires spinal fusion at more than two lumbar levels or at two non-adjacent levels.
• •Has had a prior lumbar surgical fusion procedure at the involved or adjacent spinal levels.
• •Has significant lumbar instability, defined as sagittal or coronal plane listhesis greater than Grade 2 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932).
• •Has scoliosis greater than 30 degrees.
• •Has had a previous diagnosis of osteoporosis, osteopenia, or osteomalacia.
• •In addition, if the subject has any of the following risk factors, a DEXA scan should be performed to determine eligibility:
• •History of a non-traumatic hip or spine fracture. Female who is postmenopausal. Female over the age of 65. Male over the age of 70. If the DEXA T-score is -2.5 or lower, OR a T-score of -1.5 or lower WITH a history of a vertebral compression fracture, the subject is excluded.
• •Is morbidly obese, as defined as a Body Mass Index (BMI) \> 40.
• •Has an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
• •Has an overt or active bacterial infection, either local or systemic.
• •Has undergone systemic administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
• •Has a history of clinically significant cardiac or hematologic disease.
• •Has a history of autoimmune disease known to affect bone metabolism or the spine. Examples include spondyloarthropathies (e.g., ankylosing spondylitis, Crohn's disease, and ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Grave's disease, and Hashimoto's thyroiditis.
• •Has a medical disease or condition that would preclude accurate clinical evaluation of the safety and effectiveness of the treatments in this study, such as motor weakness, sensory loss, or painful conditions that inhibit normal ambulation or other activities of daily living.
• •Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
• •Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
• •Has a history of exposure to injectable collagen.
• •Has received any previous exposure to any/all BMPs of either human or animal extraction.
• •Has a history of hypersensitivity to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).
• •Has a history of any allergy resulting in anaphylaxis.
• •Has a history of allergy to bovine products.
• •Has a documented allergy or intolerance to titanium, titanium alloy, tantalum, tantalum alloy, or polyetheretherketone (PEEK).
• •Has any condition in which MRI scans are contraindicated (e.g., cardiac pacemaker, brain aneurysm clips).
• •Has any condition in which a gadolinium-contrast MRI is contraindicated (e.g., sickle cell anemia, renal failure).
• •Is mentally incompetent. If questionable, obtain psychiatric consult.
• •Has a 'Waddell Signs of Inorganic Behavior' score of 3 or greater.
• •Is a prisoner.
• •Is a tobacco user who does not agree to suspend tobacco use prior to surgery.
• •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• •Has received treatment with an investigational therapy (drug, device and/or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.
• •Is pregnant or nursing. Female of child-bearing potential must agree not to become pregnant for one year following surgery.
• •Is a Worker's Compensation case or is involved in spinal litigation.