UMIN-CTR Clinical Trial

Basic information
Public title	Intra-articular Platelet-rich plasma for Hip osteoarthritis
Acronym	IPHOK study
Scientific Title	Intra-articular Platelet-rich plasma for Hip osteoarthritis
Scientific Title:Acronym	IPHOK study
Region	Japan

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

Objectives
Narrative objectives1	Effect of pain control of hip osteoarthritis by use of intra-articular injection of Platelet-rich plasma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) -Pain
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intra-articular hyaluronic acid
Interventions/Control_2	Intra-articular platelet-rich plasma
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	80 years-old >=
Gender	Female
Key inclusion criteria	Kellgren and Lawrence OA grade 1-3
Key exclusion criteria	post operative cases rheumatoid Arthritis cases osteonecrosis cases Blood coagulation disorder cases Infection cases BMI is more than 30 No consent is obtained
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Ikeuchi
Organization	Kochi University Kochi Medical school
Division name	Department of ortopaedic surgery
Zip code	7838505
Address	Kohasu, Ocho-cho, Nankoku, Japan
TEL	0888802386
Email	ikeuchi@kochi-u.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Okanoue
Organization	Kochi University Kochi Medical school
Division name	Department of ortopaedic surgery
Zip code	783-8505
Address	Kohasu, Ocho-cho, Nankoku, Japan
TEL	0888802386
Homepage URL
Email	okanoue@kochi-u.ac.jp

Sponsor
Institute	Kochi University Kochi Medical school
Institute
Department

Funding Source
Organization	Kochi University Kochi Medical school
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Correct health information for cooperative and innovatine development of society
Address	2-3-3 Koujimachi Chiyodaku, Tokyo ,Japan
Tel	03-5772-7584
Email	saisei@concide.or.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

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 18 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 29 Day
Date of IRB	2018 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 02 Month 18 Day
Last follow-up date	2022 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	2019 Year 02 Month 18 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040911