Unique ID issued by UMIN | UMIN000010193 |
---|---|
Receipt number | R000011938 |
Scientific Title | A phase I/II study of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the treatment of osteoarthritic knee pain. |
Date of disclosure of the study information | 2013/03/08 |
Last modified on | 2021/09/13 17:07:37 |
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
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
Japan |
Painful medial compartment of knee osteoarthritis
Orthopedics | Radiology |
Others
NO
To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound for the treatment of osteoarthritic knee pain.
1. Feasibility study (8 cases)
2. Phase I/II study (20 cases)
Safety,Efficacy
Phase I,II
Adverse events
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Magnetic Resonance-guided Focused Ultrasound treatment using ExAblate 2100 system
60 | years-old | <= |
Not applicable |
Male and Female
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.
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.
28
1st name | Motohiro |
Middle name | |
Last name | Kawasaki |
National Hospital Organization
Shikoku Medical Center for Children and Adults
Pain Management Center
765-8507
2-1-1, Senyu-cho, Zentsuji, Kagawa, Japan
0877-62-1000
im35@kochi-u.ac.jp
1st name | Motohiro |
Middle name | |
Last name | Kawasaki |
Kochi Medical School, Kochi University
Department of Orthopaedic Surgery
783-8505
Kohasu, Oko-cho, Nankoku, Kochi, Japan
088-880-2386
im35@kochi-u.ac.jp
Department of Orthopaedic Surgery, Kochi Medical School
Focused Ultrasound Foundation
Outside Japan
Kochi Medical School
Kohasu, Oko-cho, Nankoku, Kochi, Japan
088-880-2719
im62@kochi-u.ac.jp
NO
高知大学医学部附属病院(高知県)
2013 | Year | 03 | Month | 08 | Day |
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Published
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
20
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
2021 | Year | 09 | Month | 13 | Day |
2021 | Year | 08 | Month | 23 | Day |
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Main results already published
2010 | Year | 07 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 07 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 08 | Day |
2021 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011938
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