UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on the tissue repair ability and pain improvement effect of PRP on osteoarthritis
Acronym	PRP therapy for osteoarthritis
Scientific Title	Clinical study on the tissue repair ability and pain improvement effect of PRP on osteoarthritis
Scientific Title:Acronym	PRP therapy for osteoarthritis
Region	Japan

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

Objectives
Narrative objectives1	This clinical study is aimed at treating and diagnosing osteoarthritis by administering to a hospital affiliated with the university and for a patient diagnosed as requiring surgical treatment or conservative treatment in the course of the medical practice, newly devised PRP therapy By applying the law, we will conduct the repair of tissues in joints with anticipation of pain improvement effect.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Main evaluation items will be tracked and evaluated for the duration of pain control effect by VAS and evaluation by patient standing scores for 6 months every month from PRP administration. At the same time, image evaluation with MRI is performed regularly as to whether there is a fault as a secondary evaluation item
Key secondary outcomes	Regularly evaluate the presence or absence of a fault as a secondary evaluation item and image evaluation by MRI

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	Medicine Maneuver
Interventions/Control_1	PRP 1.5 mL to which the same amount of local anesthesia is added is administered intra-articularly twice every 4 weeks from the blood collection
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	1) Standing load , It is diagnosed as osteoarthritis by 4way knee joint radiography 2) It is an adult whose age is 20 years old or more at the time of consent acquisition 3) You have obtained written informed consent from the subject himself / herself 4) You have agreed that you are not taking internal medicine to control osteoarthritis pain within 2weeks of initial administration (excluding acetaminophen)
Key exclusion criteria	1) Patients undergoing intra-articular injection of steroids and hyaluronic acid formulations within 2 weeks of initial administration 2) Patients with inflammatory joint disease (such as rheumatoid arthritis disease) 3) Patients who can not comply with the instructions of a doctor 4) Pregnant or lactating women, women who may be pregnant, are not willing to contrace during clinical research
Target sample size	9

Research contact person
Name of lead principal investigator	1st name Nishihara Middle name Last name Nobuhiro
Organization	Teikyo University School of Medicine affiliated hospital
Division name	Orthopedics
Zip code	1730003
Address	2-11-1 Kaga Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	surgerynishi5524@yahoo.co.jp

Public contact
Name of contact person	1st name Nishihara Middle name Last name Nobuhiro
Organization	Teikyo University School of Medicine affiliated hospital
Division name	Orthopedics
Zip code	1730003
Address	2-11-1 Kaga Itabashi-ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	surgerynishi5524@yahoo.co.jp

Sponsor
Institute	Teikyo University School Orthopedics
Institute
Department

Funding Source
Organization	Teikyo University School of Medicine affiliated hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Teikyo University School of Medicine affiliated hospital
Address	2-11-1 Kaga Itabashi-ku, Tokyo
Tel	03-3964-1211
Email	surgerynishi5524@yahoo.co.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	帝京大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2018 Year 10 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 16 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032840