A prospective, single-arm, single-center investigator initiated trial to evaluate the efficacy and safety of 3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect

Chung-Ang Univerisity Hospital0 个研究点目标入组 10 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1. Adults who are over 19 years old and under 75 years old and have grown cheekbones
•2. Those who have definite cheekbones defect and need reconstruction and want reconstruction
•3. For women of childbearing age, those who agree to be contraceptive during the period of clinical trial participation (six months or more after surgery)
•4. Those who voluntarily agree to participate in clinical trials and are willing to comply with the protocol

•1. Those with uncontrolled metabolic disorders (eg diabetes, osteomalacia, thyroid disease)
•2. Those who are taking or taking medications that can affect bone metabolism
•? Bisphosphonate, Recombinant human parathyroid hormone (rhPTH), Denosumab, etc.
•3. Those with uncontrolled gingivitis, periodontitis, or dental caries
•4. Persons with severe heart disease or severe liver dysfunction
•5. Persons with infectious diseases at risk of recurrence
•6. Those with blood diseases (leukemia, hemophilia, sepsis, etc.)
•7. Those who can not stop steroids, antithrombotics, and anticoagulants before surgery
•8. Those who can not stop systemic corticosteroids or anabolic steroids for 3 months after surgery
•9. People with osteomalacia and Paget's disease
•10. Persons who have received radiation therapy at the surgical site
•11. Allergic to implants
•12. syphilis, severe epilepsy patient
•13. People with substance abuse or alcoholism
•14. Smokers
•15. Who is currently pregnant or who has a pregnancy plan during the clinical trial
•16. If the examiner determines that participation in the clinical trial is inadequate because it may affect other, ethical, or clinical trial results

发起方

Chung-Ang Univerisity Hospital