Painful medial compartment of knee osteoarthritis
Conditions
Interventions
Magnetic Resonance-guided Focused Ultrasound treatment using ExAblate 2100 system
Sponsors
Department of Orthopaedic Surgery, Kochi Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMotohiro Kawasaki
Kochi Medical School, Kochi University Department of Orthopaedic Surgery
Outcome results
None listed