KCT0006545已完成未知
The Safety and efficacy of combined use of Novosis and Bongros on bone fusion in adult spinal deformity patients, compared to Bongros; Randomized, double-blind, controlled, prospective, investigators initiated pilot study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
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) Adult male and female subjects aged 19 years or older and 80 years or younger
- •2) Patients with pain associated with thoracic and lumbar spinal deformity disease at 3 to 5 segments between L5 and SI who plan to perform intertransverse process lateral fusion
- •3) Those who voluntarily agreed to participate in this clinical trial and provided written consent.
- •*In general, spinal deformity is diagnosed when spinal deformity occurs more than 3 levels at thoracic and lumbar spinal.
- •This clinical trial is performed for patients with thoracic and lumbar spinal deformity disease at 3 to 5 segments between L1 and S1 who plan to perform intertransverse process lateral fusion
排除标准
- •1) Patients who have participated in other clinical trials within one month prior to enrollment in this clinical trial and received drug administration or medical device treatment
- •2) Those who have had fusion surgery in the same area
- •3) Osteoporosis on DEXA bone density test (average T-score is -3.5 under in lumbar spine L1~L4)
- •4) Immunosuppression or autoimmune disease
- •5) Patients with hypersensitivity to rhBMP-2
- •6) Those with a history of malignant tumors (allow to enroll if the disease has been completely cured and has not recurred in the past 5 years)
- •7) Those with fractures, acute infections, hemorrhagic diseases, active systemic infections, osteodystrophy, or infections at the surgical site
- •8) Patients with serious diseases that the investigator determines may affect surgery (e.g., heart failure, kidney failure, liver failure, uncontrolled blood pressure, diabetes, blood coagulation disorder, etc.)
- •9) Those who take (or plan to take) contraindicated concomitant drugs
- •10) Those with alcohol or drug addiction, mental illness
- •11) Pregnant women, lactating women, and patients who are planning to become pregnant during this clinical trial period or the women of childbearing potential who do not agree to the use of medically accepted contraceptive methods during the trial period
- •* Medically accepted contraceptive methods: condoms, oral contraceptives lasting for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives, etc.
- •12) Others, if judged by the investigator to be inappropriate for participation in this clinical trial
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