UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028688 |
|---|---|
| Receipt number | R000032840 |
| Scientific Title | Clinical study on the tissue repair ability and pain improvement effect of PRP on osteoarthritis |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2020/03/04 10:04:45 |
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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
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
surgerynishi5524@yahoo.co.jp
Sponsor or person
Institute
Teikyo University School
Orthopedics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032840
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| Registered date | File name |
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