KCT0003994已完成未知
A randomized, multi center, subject/evaluator blind, active-controlled design clinical study to evaluate the adhesion prevention and safety of Interblock® versus Hibarry ® in patients after operation for disc herniation or spinal stenosis
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Bioplus
- 入组人数
- 74
研究概览
简要总结
This study shows that Interblock was well tolerated and non-inferior to Hibarry. In addition, there were no clinically significant adverse events, and there were no clinically significant results in other safety endpoints. The results of this study show the adhesion prevention and safety of interblock in patients after operation for disc herniation or spinal stenosis.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Male and female aged 20 and over
- •2) Diagnosed with disc herniation or lumbar stenosis through radiographic (MRI or CT) evidence of nerve root compression in L2-L6 lumbar spine or fifth lumbar spine
- •3) Have plan to be operated on decompression or percutaneous lumbar discectomy for the first time
- •4) Do not lose the pain associated with disc herniation or lumbar stenosis in nonsurgical treatment
- •5) Can understand and follow the instructions and participate in the clinical trial
- •6) Voluntary written consent to participate in the Clinical trial
排除标准
- •1) With a sensitive history of hyaluronic acid
- •2) Patients with degenerative spinal cord disease or scoliosis
- •3) Patients with lymphatic or blood coaulation disease or Patients receiving anticoagulants
- •4) Patients with diabetes that can not be controlled by researcher judgment
- •5) Received steroid treatment within 2 weeks of baseline or received oral steroid within 10 days
- •6) have collagen-vascular or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus) or have been treated for malignant tumors within 5 years
- •7) Received myelogram or lumbar puncture within 24 hours of baseline
- •8) Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening
- •9) Patients who present clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that significantly affects the trial
- •10) Participated in other clinical trials within 30 days from the screening date
- •11) Persons who are likely to become pregnant during the clinical trial and who do not consent to contraception in medically acceptable ways
- •Medically acceptable methods of contraception: condoms, oral contraception for at least 3 months, use of contraceptives for injection or use, placement of intrauterine contraceptive devices, etc.
- •12) Pregnant or lactating women
- •13) In addition to the above, those who have clinical findings that the researcher judges to be inappropriate for the test
研究者
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