Clinical efficacy and safety of temperature sensitive antiadhesive agent for preventing antiadhesion after total knee arthroplasty(Prospective, single center, randomized single blind investor initiated trial)

Seoul National University Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•1) Patients who agree with participate in studies
•2) Age : 50 - 79 years
•3) Patients who was no significant unusual findings in preoperative evaluation
•4) Patients who will be taken total knee arthroplasy by primary osteoarthritis of the knee

•1) Patients who participated other studies that medicated drug or treated by medical device 1 month before register this study
•2) Previous operative history of ipsilateral knee
•3) Patients who will be treated by anti-platelet agent or general steroid within 1 weeks after total knee arthroplasty
•4) Patients who diagnosed immunosuppressive disease or autoimmune disease
•5) Patients who have allergy on anti-adhesive agent we used
•6) Patients who have general infection or infection around the knee joint
•7) Patients who diagnosed severe diseases that may affect the operation(for example, heart failure, kidney failure, liver failure, uncontrolled blood pressure, uncontrolled DM, uncontrolled anticoagulation disease)
•8) Patients who will take banned medicines in combination during clinical trial
•9) Patients who addicted alcohol or medicine, and patients who had psychiatric illness
•10) Patients who had history of Parkinson disease, sequelae of poliomyelitis, stroke
•11) Patients who had high risk of surgery due to accompanying cardiopulmonary diseases and general disease
•12) Patients who require bone graft, block, or long stem due to severe articular destruction and deformity
•13) Patients who had difficulty participating clinical trial by judge of the director of clinical trial
•14) Pregnant woman or lactating woman

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