KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion

Exclusion Criteria

• •1. Patients with open epiphyseal plates.
• •2. Patient requiring emergency spinal decompression or spinal fusion.
• •3. Patients requiring multilevel fusion or expected to need secondary intervention within one year following surgery.
• •4. Any prior fusion or attempted fusion at an adjacent level.
• •5. Any prior fusion or attempted fusion at the index level.
• •6. Pregnant or breast-feeding women.
• •7. Known or suspected allergies to any of the components of KUR-113 Bone Graft (e.g.
• •hypersensitivity to aprotinin).
• •8. Any prior use of teriparatide or abaloparatide or graft material containing PTH1-34.
• •9. Patients with hypercalcemic disorders (e.g., primary hyperparathyroidism).
• •10. Patients with Paget's Disease or unexplained high levels of alkaline phosphatase.
• •11. Prior radiation therapy involving bone.
• •12. Medical history or radiographic evidence of a metabolic bone disorder (e.g. Paget's Disease) or other condition that would negatively impact the healing process.
• •13. Any medical condition requiring radiotherapy or immunosuppression.
• •14. History of thyroid autoimmune disease (Hashimoto's thyroiditis, Graves' disease) or hyperthyroidism.
• •15. Patients on chronic systemic steroids (i.e. \> 14 consecutive days) within 6 months prior to Screening Visit.
• •16. Osteopenia (T score \< -1.0) or osteoporosis of the spine (T score \< -2.5).
• •17. DDD related to benign or malignant tumor.
• •18. History or presence of active malignancy.
• •19. Hereditary disorders predisposing to osteosarcoma.
• •20. Patients with invasive skin cancer.
• •21. Evidence of local or systemic infection.
• •22. Patients with known active COVID-19 disease.
• •23. Current smokers.
• •24. Type 1 diabetes (regardless of HbA1c) or Type 2 diabetes with a documented HbA1c \> 7.0.
• •25. Any acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to the procedure and study participation.
• •26. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs. (Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
• •27. Known substance abuse, psychiatric disorder or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
• •28. Involved in active litigation relating to his/her spinal condition or workers compensation claimants.
• •29. BMI greater than 40.