A phase I/II study of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the treatment of osteoarthritic knee pain. - MRgFUS treatment for osteoarthritic knee pain

Department of Orthopaedic Surgery, Kochi Medical School0 个研究点目标入组 20 人开始时间: 2013年3月8日最近更新: 2023年10月17日

适应症

试验速览

•1) Patient who has other knee disease including rheumatoid arthritis, infection, bone fracture, etc. 2) Patient who has severe instability of the knee joint. 3) Patients with persistent undistinguishable pain (pain source unidentifiable) 4) Patients on dialysis. 5) Patients with unstable cardiac status, severe hypertension and/or severe cerebrovascular disease. 6) Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. 7) Patients with severe coagulation disorder or on anticoagulant and antiplatelet therapy. 8) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 9) Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) 10) Bone surface of targeted knee is less than 10 mm from the skin. 11) Patients unable to communicate with the investigator and staff. 12) Patients who are participating or have participated in another clinical trial in the last 30 days 13) Any patients disqualified by a study physician because of any other reason.

发起方

Department of Orthopaedic Surgery, Kochi Medical School