Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)

Exclusion Criteria

• •1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
• •2. Lumbar spine abnormality requiring treatment at more than two levels
• •3. Systemic or local infection; active or latent
• •4. Previous failed fusion at the operative level
• •5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
• •6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
• •7. Pregnant, or plans to become pregnant during the study
• •8. Subject is a prisoner
• •9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
• •10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
• •11. Participating in another clinical study that would confound study data