None listed
Conditions
Interventions
None listed
Sponsors
Yonsei University Health System, Severance 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 spinal disease* *Here, spinal disease refers to a person who needs extensive posterior arthroplasty or posterior joint removal due to severe intervertebral disk escape or spinal stenosis, or a person with anterior spinal cord or spinal detachment, but is not limited to the disease. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fusion rate (%) evaluated based on 3D computed tomography (3DCT) results for 12 months after medical device treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone fusion rate (%) evaluated based on simple radiography (X-ray) results for 6 and 12 months after medical treatment | — |
Countries
Korea, Republic of
Contacts
Public Contactpark siyoung
Korea University Anam Hospital
Outcome results
None listed