KCT0005610尚未招募未知
Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion to treat Degenerative Spinal Disease: A prospective, randomized, Assessor blind, multicenter trial
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1. 19~75 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.
排除标准
- •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
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