3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002655

Enrollment

Registered

2018-01-09

Start date

2017-04-26

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : - Test design - This clinical trial evaluates the safety and efficacy of patient-tailored artificial zygomatic bone fabricated by applying FDM (Fused Deposition Mod

s judgment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Bone union rate / success rate of zygomatic bone	—

Secondary

Measure	Time frame
Subject Satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactUilyong Lee

Chung-Ang Univerisity Hospital

davidjoy76@gmail.com+82-2-6299-2875

Outcome results