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
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004682
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
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
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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bone union rate(%) on computed tomography (CT)
- Secondary Outcome Measures
Name Time Method 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