None listed
Conditions
Interventions
None listed
Sponsors
Koera University Guro Hospital
Ajou University Hospital
Keimyung University Dongsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 19 years of age or with confirmed skeletal maturity (with radiologic evidence of epiphysal closure) 2) Patients requiring bone grafting due to acute fracture of traumatic lower extremities 3) Written consent to participation in this clinical study
Exclusion criteria
Exclusion criteria: 1) A person who does not agree to maintain contraception for one year after the procedure if he/she is pregnant, lactating, or a woman of childbearing age 2) Patients with malignancy or active malignancy 3) Patients with a history of cancer in the past and potential for metastasis (Nobosis is applicable if the disease has been cured and has not recurred in the past 5 years) 4) Patients with active infection at the surgical site 5) Patients with uncontrolled diabetes or hypertension or have blood clotting abnormalities 6) Hydroxyapatite, a person who has a history of overreaction to BMP-2 7) a patient with difficulty in follow-up 8) Patients with compartment syndrome of infected limb (limb) 9) For applications requiring strength 10) A person who does not use this product according to the following indications: - In case the internal/external fixation device cannot be used with the internal/external fixation rod and fracture joint plate during upper/lower fracture fusion - Patients with inadequate neurovascular conditions (e.g. high-risk amputations) during upper and lower limb fracture fusion - In the case of bone defect due to chronic fracture during upper and lower limb fracture fusion surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of bone fusion evaluated based on simple radiography (X-ray) results for 12 months after medical treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone fusion rate (%) evaluated based on simple radiography (X-ray) results for 6 months after medical treatment;Treatment success rate (%): Number of bone fusion subjects without additional intervention / total subjects x 100;Rate of occurrence of additional intervention (%): Describe the frequency with which additional intervention was performed to induce bone fusion. | — |
Countries
Korea, Republic of
Contacts
Public Contactoh jongkeon
Koera University Guro Hospital
Outcome results
None listed