UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation and therapeutic effect analysis of knee hyperthermia with resonant cavity applicator
Title of the study (Brief title)	Analysis of knee hyperthermia with resonant cavity applicator
Region	Japan

Condition
Condition	osteoarthritis of the knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To perform thermal therapy using a resonant cavity applicator for healthy knee and osteoarthritis of the knee (knee OA), and to confirm safety and to analyze influence on clinical symptoms
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) in 6 months from treatment start
Key secondary outcomes	Improvement of MRI T2 value of articular cartilage at 6 months from the start of treatment. Confirmation that no adverse event occurs.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	20-40 W 20 min thermal therapy once every 1 to 4 weeks 10 times in total 6 months or less
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Osteoarthritis of the knee, KL grade 2-4
Key exclusion criteria	Pregnant Cases who can not enforce MRI examination
Target sample size	20

Research contact person
Name of lead principal investigator	Kenji Takahashi
Organization	International University of Health and Welfare Hospital
Division name	Department of Orthopaedic Surgery
Address	537-3 Iguchi, Nasushiobara, Tochigi,329-2763, Japan
TEL	+81-287-39-3060
Email	t-kenji@iuhw.ac.jp

Public contact
Name of contact person	Kenji Takahashi
Organization	International University of Health and Welfare Hospital
Division name	Department of Orthopaedic Surgery
Address	537-3 Iguchi, Nasushiobara, Tochigi,329-2763, Japan
TEL	+81-287-39-3060
Homepage URL
Email	t-kenji@iuhw.ac.jp

Sponsor
Institute	nternational University of Health and Welfare
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 11 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 04 Month 30 Day
Date trial data considered complete	2019 Year 05 Month 10 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 11 Day
Last modified on	2019 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038453