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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: Magnetic Resonance‐guided Focused Ultrasound treatment using ExAblate 2100 system CONDITION: Painful medial compartment of knee osteoarthritis PRIMARY OUTCOME: Adverse events SECONDARY OUTCOME: knee pain, measured by numerical rating scale; Quality of life, measured by questionnaires ; Tenderness, measured by pressure pain threshold; Motor function of the treated knee joint INCLUSION CRITERIA: 1) Men and women age 60 years and older. 2) Patients who are able and willing to give consent and able to attend all study visits. 3) Patients who are able to communicate sensation during MRgFUS. 4) Patients who are suffering from pain caused by medial compartment of knee osteoarthritis and also consider whether an operation is performed on. 5) Pain scores on the numerical rating scale (0‐10 scale) is more than 4. 6) Knee pain is resistance to conservative therapy and continues for more than 6 months. 7) Patient who has tenderness inside knee joint. 8) Kellgren and Lawrence grade of targeted knee is more than 3 9) Targeted lesion clearly visible by non‐contrast MRI, and ExAblate MRgFUS device accessible.
Epistemonikos ID: e27602eff1ce33693a1f46f8b3b13868686107bc
First added on: Aug 22, 2024