KCT0007240尚未招募未知
Comparison of effectiveness and safety according to the composition of bone graft material used with bioactive glass-ceramic cage (Novomax Fusion™) in cervical discectomy and fusion (ACDF): a prospective, controlled, single-blind, therapeutic exploratory study
The Catholic University of Korea, Eunpyeong St. Mary's Hospital0 个研究点目标入组 45 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
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 ~ 80 years old
- •2) The application of bioactive crystallized glass cage products to the multi-segment between C3 and T1 is required. Patients with degenerative cervical disease who require anterior cervical disc removal and fusion are associated with the following clinical signs and symptoms:
- •a. Symptoms and signs radiating to one or both arms (pain, paresthesia, or paralysis depending on the distribution of specific nerve roots) or symptoms and signs related to acute or chronic myelopathy
- •b. Imaging diagnosis of cervical disc herniation and/or osteophyte formation associated with clinical symptoms and signs of a. (C3-C4 to C7-T1)
- •3) Subjects willing to participate in clinical trials, comply with treatments and procedures, and visit hospital for all observational evaluations
- •4) Subjects who voluntarily signed the written consent after hearing the explanation of the purpose and method of this clinical trial
- •5) Subjects undergoing surgery using bioactive crystallized glass cage (Novomax Fusion Cage) in cervical disc removal and fusion
排除标准
- •1) Subjects with only cervical pain with uncertain or no radiating symptoms or myelopathy
- •2) Subjects with osteoporosis with an average hip joint T-score less than -3.5 on the DEXA bone density test
- •3) Subjects with a history of interbody fusion at the site to be evaluated
- •4) Subjects who have already had the same procedure in another segment of the cervical spine
- •5) Subjects who are pregnant or lactating, or those of childbearing age who do not agree to maintain contraception during the clinical period
- •6) Subjects who have taken anticoagulants, steroids, or corticosteroids for a long period of time (e.g., 10 mg of Dexametasone per day for 4 weeks or more)
- •7) Subjects with uncorrected blood coagulation disorders (Platelet<50,000/?, PT(INR)>2)
- •8) Subjects with a history of hypersensitivity to BGS-7
- •9) Subjects who are judged to be difficult to progress because they have been diagnosed with the following diseases:
- •a. Severe mental illness, epilepsy
- •b. History of malignancy (However, subjects who have been cured and have not recurred in the past 5 years can participate)
- •c. Narcotic drugs and severe alcoholism
- •d. Severe heart disease or liver dysfunction
- •e. Metabolic diseases: osteomalacia, Paget's disease
- •f. Risk of recurrence Patients with infectious diseases, patients with blood diseases
- •10) Subjects judged to be inappropriate to participate in clinical trials by other investigators:
- •a. Those who cannot read or understand the consent form (illiterate, foreigner, mentally retarded)
- •b. Those who are judged to be difficult to conduct this clinical trial due to the judgment of the principal investigator
研究者
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