None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Based on the image data (CT) of the subject who underwent step 1 of the induction membrane method, a test device (3D printed patient-specific bio-ceramic (BGS-7) me
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone union rate(%) on computed tomography (CT) | — |
Secondary
| Measure | Time frame |
|---|---|
| bone union rate(%) on computed tomography (CT);Bone union rate(%) on simple radiographs;Bone Graft Implants Fixation Success Rate(%);AOFAS Score Improvement;VAS Score Improvement | — |
Countries
Korea, Republic of
Contacts
Public Contactoh keon
Koera University Guro Hospital
Outcome results
None listed