KCT0007176尚未招募未知
The efficacy and safety of milled PEEK(Polyetheretherketone) implant for Facial bone reconstruction
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 75?(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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