Prospective study of intervertebral height expansion effect and restoration of lordotic angle and safety of transforaminal lumbar interbody fusion using expandable cage : a prospective, multicenter trial

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新: 2023年10月16日

适应症

试验速览

暂无简介。

•1. Adults between the ages of 19 and 75
•2. Patients with lumbar degenerative intervertebral disc disease requiring intervertebral fusion between L2 and S1
•3. Patients who have heard and agreed in writing voluntarily, are willing to comply with the protocol, and are willing to visit the hospital to evaluate the observation items

•1) Patients with non-degenerative lumbar disorders such as spinal trauma, spinal tumors, spinal infections and inflammation, and re-operation
•2) Pregnant, lactating, or pregnant women who plan to conceive or disagree with medically acceptable contraception during this trial * Medically acceptable contraception: condoms, oral contraceptives lasting at least 3 months, injections or implantation, etc
•3) Malignant tumor patients within 5 years
•4) Patients taking chronic steroids and corticosteroids [for example, when taking dexamethasone at a dose of 10mg per day for more than 4 weeks]
•5) Those currently diagnosed with the following diseases: A)Severe heart disease or liver dysfunction B) Infectious disease, uncorrected blood clotting disorder (platelet<50,000/µl, PT-INR>2.0) C) Osteomalacia, Paget's disease D) Others (syphilis, severe epilepsy, alcohol/drug addiction)
•6) Those who have had an allergic reaction or are sensitive to the product itself or its components, which are medical devices of this clinical trial
•* Raw materials for medical devices for clinical trials: titanium alloy (Ti-6AI-4VELLI)/PEEK (Polyether ether ketone)/Tantalum
•7) Those who have participated in other clinical trials within the last 6 months
•8) Those who are judged inappropriate for clinical trials by the principal investigator or other researchers

发起方