Safety and Effectiveness Evaluation of Bioactive glass ceramic cage in Anterior Cervical Discectomy and Fusion

Yonsei University Health System, Severance Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新: 2020年12月2日

试验速览

暂无简介。

•1) adults aged 19 to 80
•2) Patients with degenerative cervical disease in 1 level between C3 and T1 requiring Anterior cervical discectomy and fusion using the bioactive glass-ceramic cage.
•a. Symptoms and signs radiating to one or both arms (e.g. pain, dysentery, or paralysis from the distribution of specific neurons) or related to acute or chronic spinal cord disease
•b. Visual diagnosis of Cervical Herniation(Herniated) of Inter-Vertebral Disc and (or) bone formation (from C3-4 to C7- T1)
•3) Willing to participate in clinical trials, treatment and obsevative procedures, and visit hospital

•1) In the case of cervical pain without any uncertainty of radiated symptoms or spinal cord disease
•2) Subject who has a history of interbody fusion in target site.
•3) Subject with a history of malignant tumors (although the current condition has been cured and can be registered if it has not recurred in the last 5 years).
•4) if pregnant or breastfeeding, or Subject with not agree to maintain contraception during clinical trial.
•5) subject who have taken anticoagulant agent, steroids, and adrenal cortical hormones for a long period of time (e.g., those who have taken 10 mg per day on the Dexametasone for more than four weeks)
•6) Subject with an uncorrected blood coagulation disorder (Platelet <50,000/ul, PT(INR)>2)
•7) Subject with hypersensitivity BGS-7
•8) Subject who is diagnosed with the following diseases and is deemed difficult to clinical trial:
•f. Severe mental illness, epilepsy
•g. Addictive narcotics and alcoholism of severe degree
•h. Severe heart disease or liver dysfunction
•i. Metabolic disease: osteomalacia, Paget disease
•j. Inflammatory patients with relapse risk, blood patients
•9) Other persons deemed inappropriate to participate in clinical trials by the investigator.

发起方