UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035910 |
|---|---|
| Receipt number | R000040911 |
| Scientific Title | Intra-articular Platelet-rich plasma for Hip osteoarthritis |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2021/02/19 09:27:20 |
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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
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
okanoue@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University Kochi Medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040911
