KCT0004682招募中未知
Evaluation of the efficacy and safety of 3D-printed personalized bioceramic (BGS-7) medical device on tne patient who underwent induced membrane technique to treat tibial bone defect (cortical bone length 1~5cm) caused in the traumatic open fracture: A prospective, single center, single arm, open label, investigator-initiated therapeutic pilot study
Koera University Guro Hospital0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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 70(Year)（—）
- 性别
- All
入选标准
- •1. 19 to 70 years old
- •2. Patients requiring guide membrane technology to treat tibial defects (cortical bone length 1-5 cm) in traumatic fractures
- •- For 41-A, 42-A, B, C, 43-A in the subgroup of AO / OTA Fracture and Dislocation Classification
- •- Cortical bone length 1 ~ 5 cm, defect including more than 50% of cortical bone circumference
- •3. Those who are willing to participate in the study, to follow treatments and procedures, and to visit the hospital for all observational evaluations.
- •4. Person who voluntarily signed written consent after explaining the purpose and method of this study
排除标准
- •1. Subject who with cartilage fracture at the site of application.
- •2. Subject who are diagnosed with the following diseases and who find it difficult to proceed with surgery
- •A. Uncontrolled diabetes, high blood pressure
- •B. Severe heart disease, severe liver dysfunction
- •C. Infectious Diseases with Risk of Recurrence
- •D. Blood diseases (leukemia, hemophilia, sepsis, etc.)
- •E. Osteomalacia, paget disease
- •F. Syphilis, severe epilepsy
- •G. Narcotic Drugs and Alcoholism
- •H. Pituitary dysfunction, (para)thyroid gland dysfunction, and other bone metabolic disorders
- •3. Subject who cannot prohibit drugs that may affect the bone metabolism during Combination Contraindication period of no use
- •[Combination Prohibited drugs]
- •1) A week before the surgery until the end of study
- •- Drugs Prohibition that directly affects the treatment site (adrenocortical hormone, Parathyroid hormone, ect)
- •- prohibition of antiresorptive agents(bisphosphonates, denosumab, ect)
- •- whole body steroids prohibition
- •2) A week before the surgery until the Visit4(three months after the surgery)
- •- prohibition of NSAIDs
- •4. Subject who cannot stop taking antithrombotic agent and anticoagulant agent before surgery
- •5. Subject who have a history of hypersensitivity to BGS-7
- •6. pregnant or lactating women or who is planning to pregnancy or disagree with medically permitted contraception during this clinical trial
- •(Medically accepted contraceptives: condoms, oral contraceptives lasting at least three months, use of injectable or injectable contraceptives, intrauterine contraceptive device is installed, etc.)
- •7. Persons deemed difficult to conduct this clinical trial by the principal investigator's judgment
- •(If you cannot perform the tests required by this study, or if you have other medical conditions that you deem inappropriate)
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