None listed
Conditions
Interventions
Medical Device : Surgery is performed in the same way as posterior lumbar interbody fusion (PLIF). Depending on the number of levels to PLIF, a 3-6 inch incision is made to allow access to the vertebr
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19~79 years of age at the date of written informed consent 2. Patients requiring single- or double-level PLIF with pedicular fixation for the following reasons 1) Spinal Stenosis 2) Intervertebral disc disease 3) Spondylolysis or spondylolisthesis 4) Recurrent Lumbar Disc Herniation etc. 3. Signed and dated informed consent form
Exclusion criteria
Exclusion criteria: 1. 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 2. Patients with a history of malignant tumors in the past 5 years 3. Those who have removed the tumor at graft site 4. Those who are undergoing anticancer therapy 5. Those who are diagnosed with the following disease 1) Mental illness 2) Drug intoxication and alcoholism 3) Liver cancer, liver cirrhosis 4) Acute/chronic infection 5) Acute/chronic renal failure 6) Elimination Disorders 7) Active Tuberculosis 8) Rickets, osteomalacia 9) Hypopituitarism, hyperpituitarism 10) Hypothyroidism, hyperthyroidism, hypoparathyroidism, hyperparathyroidism 11) Metabolic bone disease 6. Those who can’t stop taking antithrombotic or anticoagulant before surgery 7. Uncontrolled diabetes or hypertension or blood coagulation defect 8. Hypersensitivity to rhBMP-2, Beta-tricalciumphosphate 9. Previous surgical histroy on same level 10. Immune suppression or autoimmune disease 11. Vertebral body or disc infection on surgical site 12. Severe osteoporosis on DEXA bone density test (A T-score is -3.5 under) 13. Patients who have participated in other medical device clinical trials within six months (For clinical trials of drugs, within 30 days) 14. Others, if judged by the investigator to be inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rates of intervertebral | — |
Secondary
| Measure | Time frame |
|---|---|
| Fusion rates of intervertebral;Rates of subsidence;Improvement compared to pre-operative VAS, ODI score | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung-Sik Ryu
The Catholic University of Korea
Outcome results
None listed