Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture

Exclusion Criteria

• •1. Patients or their family members with a history of an or an ongoing autoimmune disease
• •2. Patients with a history of anaphylactic response
• •3. Patients with hypersensitivity to grafting materials
• •4. Patients with hypersensitivity to porcine protein
• •5. Patients with osteomyelitis in the surgery area
• •6. Patients who are pregnant, breastfeeding, or planning to become pregnant
• •7. Patients with other tumors or a non-curable disease
• •8. Patients with a history of radiation therapy or cancer treatment within two years (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
• •9. Patients with diabetes (Those who maintain a normal blood sugar level and did not develop complications may receive the SurgiFill™ injection based on the investigator's judgment, but the doctor's confirmation is required.)
• •10. Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
• •11. Patients who have been undergoing adrenocortical hormone therapy (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
• •12. Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment. Hypertension patients are allowed.)
• •13. Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
• •14. Patients with chronic renal failure or an endocrine system disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
• •15. Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment
• •16. Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)