UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Molecular biological and physical analysis of hyaluronan injection with mechanical stress on osteoarthritis
Title of the study (Brief title)	Hyaluronan treatment with mechanical stress on osteoarthritis
Region	Japan

Condition
Condition	osteoarthritis
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The analysis of Hyaluronan injection with mechanical stress treatment lead better therapy on osteoarthritis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	type II collage telopeptide, hyluronan, cytokine, adipokine, free glycosaminoglycan, matrix degrading enzyme
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	hyaluronan
Interventions/Control_2	mechanical stress
Interventions/Control_3	hyaluronan with mechanical stress
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed as osteoarthritis.
Key exclusion criteria	Patients diagnosed as rheumatism or secondary osteoarthritis.
Target sample size	200

Research contact person
Name of lead principal investigator	Satoshi Hirohata
Organization	Okayama University Graduate School of Health Sciences
Division name	Department of Medical Technology
Address	2-5-1 Shikata-cho, Kita-ku,Okayama
TEL	086-235-6897
Email	hirohas@cc.okayama-u.ac.jp

Public contact
Name of contact person	Takashi Ohtsuki
Organization	Okayama University Graduate School of Health Sciences
Division name	Department of Medical Technology
Address	2-5-1 Shikata-cho, Kita-ku,Okayama
TEL	086-235-6897
Homepage URL
Email	pebm12z8@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Health Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	坂田整形外科医院

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 11 Month 02 Day
Last modified on	2016 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018112