UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II study of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the treatment of osteoarthritic knee pain.
Acronym	MRgFUS treatment for osteoarthritic knee pain
Scientific Title	A phase I/II study of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the treatment of osteoarthritic knee pain.
Scientific Title:Acronym	MRgFUS treatment for osteoarthritic knee pain
Region	Japan

Condition
Condition	Painful medial compartment of knee osteoarthritis
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Adverse events
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Magnetic Resonance-guided Focused Ultrasound treatment using ExAblate 2100 system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Kawasaki
Organization	National Hospital Organization Shikoku Medical Center for Children and Adults
Division name	Pain Management Center
Zip code	765-8507
Address	2-1-1, Senyu-cho, Zentsuji, Kagawa, Japan
TEL	0877-62-1000
Email	im35@kochi-u.ac.jp

Public contact
Name of contact person	1st name Motohiro Middle name Last name Kawasaki
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopaedic Surgery
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL	088-880-2386
Homepage URL
Email	im35@kochi-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Kochi Medical School
Institute
Department

Funding Source
Organization	Focused Ultrasound Foundation
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
Tel	088-880-2719
Email	im62@kochi-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	高知大学医学部附属病院（高知県）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 08 Day

Related information
URL releasing protocol	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Publication of results	Published

Result
URL related to results and publications	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Number of participants that the trial has enrolled	20
Results	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Results date posted	2021 Year 09 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 08 Month 23 Day
Baseline Characteristics	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Participant flow	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Adverse events	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Outcome measures	https://www.tandfonline.com/doi/full/10.1080/02656736.2021.1955982
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 07 Month 01 Day
Date of IRB	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 03 Month 08 Day
Last modified on	2021 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011938