Efficacy of Using Solum IV and BMC With GFC in TLIF

Exclusion Criteria

• •1. Previous bilateral Iliac Crest Bone Graft (ICBG) harvest
• •2. Previous instrumented fusion at the same or adjacent level
• •3. Active systemic infection, infection localized to the site of implantation or at aspiration site
• •4. Vulnerable patients
• •1. Nursing home residents
• •2. Prisoners
• •3. Other institutionalized persons
• •4. Persons with decisional incapacity
• •5. Pregnant women or interested in becoming pregnant in the next 12 months
• •6. Subjects with certain autoimmune diseases (such as lupus)
• •7. Subject has progressive neuromuscular disease
• •8. Active hepatitis, AIDS, ARS or is HIV positive
• •9. Syringomyelia at any spinal levels
• •10. Any other condition that would interfere with the subject self-assessment of pain, function or quality of life
• •11. Subjects with multiple allergies
• •12. Subjects with any history of cancer (except for basal cell carcinoma of the skin)
• •13. Significant osteoporosis
• •14. Subject is younger than or equal to 18 years of age
• •15. Subjects with a BMI of 40 or greater
• •16. Subject has diabetes mellitus requiring daily insulin management
• •17. Subject has allergy to implant materials (such as titanium, titanium alloy)
• •18. Subject has primary or metastatic tumors involving the spine
• •19. Subject is participating in another investigational study for a similar purpose
• •20. Subject has a history of significant mental illness or mental incapacity
• •21. Subject is currently smoker and will not cease smoking from the time of study enrollment up through 3 months post-operatively, nicotine users for whom post-operative bone stimulation would be prescribed, or has a recent history of alcohol or other substance abuse within the past 2 years
• •22. Subject is receiving workers compensation
• •23. Absence of English language reading or writing skills
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