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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028688
Receipt No. 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 2017/08/16

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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
Middle name
Last name Nobuhiro Nishihara
Organization Teikyo University School of Medicine affiliated hospital
Division name Orthopedics
Zip code
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
Middle name
Last name Nobuhiro Nishihara
Organization Teikyo University School of Medicine affiliated hospital
Division name Orthopedics
Zip code
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
Address
Tel
Email

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
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
2017 Year 08 Month 16 Day


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

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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