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

Phase 1
Conditions
Painful medial compartment of knee osteoarthritis
Registration Number
JPRN-UMIN000010193
Lead Sponsor
Department of Orthopaedic Surgery, Kochi Medical School
Brief Summary

https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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