None listed
Conditions
Interventions
Medical Device : For those who need reconstruction due to bone defects diagnosed by CT (or MRI) (facial bone defects refer to bone defects in skulls (facial bones), orbital bones, and cheekbones, and
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: selection criteria 1. Adult men and women over 19 and under 75 2. Those who need reconstruction and want reconstruction due to bone defects in the face diagnosed by CT (or MRI) (Facial bone defect refers to bone defects in the skull (forehead), orbital bone, and cheekbones, and even if the cause of facial asymmetry after trauma and tumor surgery is bone potential, the insufficient portion is bone defects compared to the normal side. 3.Who agreed to replace and support the defect site with PEEK Patient Specific Implant (PRIMARY-P) developed by CusMedi Co., Ltd. 4. In the case of women, those who have agreed to contraception during the clinical trial period (6 months or more after surgery) 5. Those who agree to participate in clinical trials (subjects and/or agents) and are able to visit for scheduled observations during clinical trials
Exclusion criteria
Exclusion criteria: exclusion criterion 1. If there is a serious infectious disease under the judgment of the examiner. 2. If there is an infectious disease in the surgical site and other surrounding areas under the judgment of the testee, 3. Those with unregulated metabolic diseases (e.g., diabetes, osteomalacia, thyroid disease) 4. A person who is or is planning to take a drug that may affect bone metabolism 5. Patients with immature skeletal structure 6. Persons with severe heart disease or severe liver dysfunction 7. Those with infectious diseases at risk of recurrence 8. Those with blood diseases (leukemia, hemophilia, septicemia, etc. 9. Those who have received radiation therapy at surgical sites 10. Those who have hemorrhagic diseases or need anticoagulants 11. Those who are allergic to implant materials 12. Person who is substance abuse or alcoholics 13. Smokers 14. Pregnant or lactating women who are positive for pregnancy tests performed during screening 15. Other cases where the tester determines that participation in clinical trials is inappropriate because it may affect the results of other, ethical or clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy : achievement of tissue reconstruction;efficacy: patient satisfaction | — |
Countries
Korea, Republic of
Contacts
Public ContactDong Yeon Kim
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed