Clinical trial to evaluate the safety and efficacy of NOVOSIS INJECT for posterior instrumentation & posterior lumbar interbody fusion; A single site, prospective, investigator initiated trial

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•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

•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

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