None listed
Conditions
Sponsors
Seoul National University Bundang Hospital
Chung-Ang Univerisity Hospital
Hanyang University Seoul Hospital
Hallym University Medical Center-Kangnam
Yonsei University Health System, Gangnam Severance Hospital
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19~80 years of age at the date of written informed consent 2. Patients requiring one- or two-level laminectomy with fusion for the following reasons (This clinical trial is performed for patients who do not respond despite 3 months of conservative treatment or who continue to have pain with a VAS score of 4 or higher.) 1) Spinal Stenosis 2) Severe herniated disc with neurologic deficit (such as cauda equina syndrome) 3) Spondylolysis or spondylolisthesis 4) Recurrent Lumbar Disc Herniation etc. 3. It able to comply with the study plan and can visit every follow-up for this study 4. It able to understand and sign the subject Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Prior interbody surgery at the same level 2. Pregnant or lactating women, or those who are planning pregnancy for the duration of this clinical trial or don't agree to medically accepted contraceptive methods * Medically accepted contraceptive methods: condoms, oral contraceptives for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives, etc. 3. Severe osteoporosis on DEXA bone density test (DEXA T-score is -3.0 or lower) 4. Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 5 year 5. Hypersensitivity to rhBMP-2, Hydroxyapatite,PEEK. 6. Those who are diagnosed with the following disease. 1) Mental illness 2) Drug intoxication and alcoholism 3) liver disease; Liver cancer, cirrhosis, acute/chronic hepatitis4) Acute/chronic renal failure 4) kidney disease; Acute/chronic renal failure, Elimination disorders 5) heart disease; Severe heart failure 6) respiratory diseases; Active tuberculosis 7) infectious diseases; Active systemic infection and application site infection 8) metabolic diseases; Rickets, osteomalacia, pituitary dysfunction, thyroid dysfunction, and other bone metabolic disorders 9) fracture of the applied area; osteoporotic vertebral fracture, spine trauma fracture 7. Those who can’t prohibit drugs (parathyroid hormone, bisphosphonate, Systemic Steroid) that may affect bone metabolism during the prohibition period 8. Those who severe autoimmune disease 9. Those who smoke more than 20 per day 10. BMI > 35 kg/m2 11. Those who can’t stop taking antithrombotic or anticoagulant before surgery 12. Uncontrolled diabetes or hypertension or blood coagulation defect 13. terminal patient 14. Those who cannot understand the purpose and method of clinical trials 15. Patients who have participated in other medical device clinical trials within six months (For clinical trials of drugs, within 30 days) 16. Others, if judged by the investigator to be inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fusion rate on CT after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone fusion rate on CT after surgery (%) : evaluation by surgical site(level);Serial ODI score changes after surgery;Serial EQ-5D score changes;Serial VAS score changes | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-Min Park
Seoul National University Bundang Hospital
Outcome results
None listed