None listed
Conditions
Interventions
Medical Device : Interventional medical devices
Medical Equipment Items: Class 4 Synthetic Material Edible Bone
Intervention protocol : The study was conducted in patients with femur bone fracture and
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adults aged 19 to 80 ? Femur fracture patients who require bone grafting and bone grafting ? Those who fully understand the purpose and procedures of the test and voluntarily agree to participate in the clinical trial
Exclusion criteria
Exclusion criteria: ? Person who are pregnant or lactating, or who are pregnant and do not agree to maintain contraception during the clinical period ? Person with a history of malignant tumors (the disease has been cured and recurred for the past 5 years If not, registration is possible). ? Person whose blood calcium and phosphorus levels exceed [30% of normal range lower limit + 30% of upper limit range] ? If you are diagnosed with the following diseases • Mental illness • Drug and alcohol addiction • Liver disease: liver cancer, liver cirrhosis, acute / chronic hepatitis • Respiratory disease: active tuberculosis • Metabolic disorders: rickets, osteomalacia, pituitary dysfunction, (part) thyroid dysfunction, hereditary bone metabolic disorders • Kidney disease: acute / chronic renal failure, excretory dysfunction ? Any person who is found to be unfit for participation in clinical research due to other reasons ? Currently participating in other clinical trials or participating in other clinical trials within one month before enrolling in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Synostosis by CT | — |
Secondary
| Measure | Time frame |
|---|---|
| Synostosis by X-ray;Visual Analog Scale(VAS) | — |
Countries
Korea, Republic of
Contacts
Public ContactSUN-JUNG YOON
Jeonbuk National University Hospital
Outcome results
None listed