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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035910
Receipt No. R000040911
Scientific Title Intra-articular Platelet-rich plasma for Hip osteoarthritis
Date of disclosure of the study information 2019/02/18
Last modified on 2019/08/20

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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
2021 Year 08 Month 18 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
2019 Year 08 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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