KCT0005328招募中未知
Evaluation of efficacy and safety of NOVOSIS, BONGROS, EXCELOS INJECT on the single lever or consecutive 2-3 level of L2~S1 patient who underwent in Oblique lumbar interbody fusion to treat Degenerative Spinal Disease: Single-arm, Prospective, Investigators-initiated Pilot study
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 80
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
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Over 20 years old
- •2) A patient who needs Oblique lumbar interbody fusion in 1 level or 2 ~ 3 levels between L2 ~ S1 due to one of the following degenerative lumbar diseases
- •? Spinal canal stenosis
- •? Herniation of intervertebral disc
- •? spondylolisthesis or spondylolysis
- •3) Those who are willing to participate in the trial, follow treatment and procedures, and visit the hospital for evaluation of all observations
- •4) A person who has voluntarily signed a written consent after hearing the purpose and method of this clinical trial.
排除标准
- •1)1) Patients with severe osteoporosis (e.g., those with osteoporosis with an average T-score <-4.0 of the lumbar spine L1 to L4, or Z-score <-3.0 with osteoporosis in young women) on the DEXA)
- •2) Fracture of the application site (osteoporoticvertebral fracture, spine trauma fracture), acutely infected subjects, patients with hemorrhagic disease, patients with bone formation disorder
- •3) Those who have a history of fusion at the application site
- •4) A person with a history of malignancy (can be registered if the disease has been cured and has not relapsed in the past 5 years)
- •5) Patients with hypersensitivity to HA, ß-TCP, rhBMP-2
- •6) Those who are pregnant or lactating, who are planning to become pregnant during this trial or who do not agree with medically acceptable contraception.
- •7) Those who are diagnosed with the following diseases and are judged to have difficulty in surgery
- •? Uncontrolled diabetes, high blood pressure
- •? Mental illness: When conducting or complying with clinical trials is difficult
- •? Drug and alcohol addiction
- •? liver disease: liver cancer, cirrhosis, acute/chronic hepatitis
- •? Kidney disease: acute/chronic renal failure, impaired excretory function
- •? Heart disease: severe heart failure
- •? respiratory diseases: active tuberculosis
- •? Infectious diseases: active systemic infection and application site infection
- •? Metabolic diseases: rickets, osteomalacia, Paget's disease, pituitary dysfunction, (secondary) thyroid dysfunction, and other bone metabolic disorders
- •8) People who have long-term steroids, anticoagulants, etc.
- •9) Long-term use of anticoagulants
- •11) Persons who cannot prohibit drugs that may affect bone metabolism during the prohibition period
- •12) A terminal patient
- •13) Those who cannot understand the purpose and method of the clinical trial
- •14) Those who participated in another medical device intervention clinical trial within 6 months before participating in this study (for drug intervention clinical trials, those who participated within 30 days)
- •15) Subjects deemed difficult to conduct this clinical trial at the judgment of the responsible investigator
研究者
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