KCT0004682
Recruiting
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 sites5 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Sponsor
- Koera University Guro Hospital
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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