KCT0007176
Not Yet Recruiting
N/A
The efficacy and safety of milled PEEK(Polyetheretherketone) implant for Facial bone reconstruction
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, St. Vincent's Hospital
- Enrollment
- 10
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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
Outcomes
Primary Outcomes
Not specified
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