KCT0005259已完成未知
Clinical Study to Evaluate the Efficacy and Safety of NOVOSIS PUTTY in Patients Lumbar Disc Degeneration require Transforaminal Lumbar Interbody Fusion (TLIF) with Instrumentation fixation: Investigator Initiated Trial, Single group, multicenter, prospective, exploratory clinical trial.
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
- Information on the subjects of the study - Target number of people: 30 -Number of people screened: 31 -Number of registered persons: 30 (one failed screening) *Number of registered persons by institution -Chungbuk National University Hospital: 10 patients (7 completed / 3 dropped out) -Seoul Asan Medical Center: 15 patients (11 completed / 4 dropped out) -Gangnam Severance Hospital: 5 people (2 completed / 3 dropped out) 2. the results of the study Primary Validation Variables: CT scan bone union rate at 52 weeks of surgery (%) - 100% union rate Secondary Validation Variables: CT scan bone union rate at 26, 39, and 104 weeks after surgery (%) -26 weeks 80.77% and 39 weeks 78.26% (three people were eliminated and parameters changed), and 104 weeks 100% 3. Abnormal reactions, including significant adverse reactions that occurred during the study, and their contents There were two adverse reactions, glaucoma and lower backpain, but they were not significant adverse reactions, and both cases had mild risk and had little relevance to medical devices. 4. Outcome Summary Thirty target subjects were registered, and the CT bone union rate at 52 weeks of surgery, the primary validation item, was measured 100%.
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
- •A subject need to meet the following conditions.
- •1)Male or female subjects between 18 and 80 years of age.
- •2)Subjects who diagnosed Degenerative Disc Disease at one or two level from L2 to S1
- •?Spinal stenosis
- •?Herniated Intervertebral disc
- •?Spondylolisthesis or spondylosis
- •3) Those who are willing to participate in the trial, comply with 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) Those who have a history of spinal surgery or tumor removal at the application site
- •2) Those with a history of fusion or intervertebral disc replacement in the lumbar region
- •3) Examples of serious metabolic diseases affecting bone growth, Paget's disease, osteoporosis, osteopenia, myeloma factors
- •4) Patients with severe osteoporosis, such as those with osteoporosis with an average T score < 3.0 of the lumbar spine L1 to L4 on the DEXA bone density test
- •5) Patients with hypersensitivity to Hydroxyapatite, rhBMP 2
- •6) Persons who cannot prohibit drugs that may affect bone metabolism during the prohibition period
- •7) People with systemic infection and/or acute infection at the site of application.
- •8) Those who have a history of drug and alcoholism within 2 years
- •9) It is possible to register if the child's disease with a history of malignancy has been cured and has not relapsed in the past 5 years.
- •10) Subjects deemed difficult to perform this clinical trial at the judgment of the responsible researcher
- •11) People with congenital bone and/or spinal cord abnormalities that may affect spinal safety
- •12) Those who are pregnant or lactating, who are planning to become pregnant during this trial or who do not agree with medically acceptable contraceptive methods.
- •* Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, contraceptives for injection or implantation, intrauterine contraceptives, etc.
- •13) Those who cannot understand the purpose and method of the clinical trial
- •14) Participants who participated in another medical device intervention clinical trial within 6 months before participating in this trial.
研究者
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