UMIN-CTR Clinical Trial

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

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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 or person

Institute

Department of Orthopaedic Surgery, Kochi Medical School

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011938


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name