UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on safety assessment of PRP therapy for development dysplasia of hip
Acronym	Clinical study on safety assessment of PRP therapy for development dysplasia of hip
Scientific Title	Clinical study on safety assessment of PRP therapy for development dysplasia of hip
Scientific Title:Acronym	Clinical study on safety assessment of PRP therapy for development dysplasia of hip
Region	Japan

Condition
Condition	Patients who is diagnosed Hip osteoarthritis (Kellgren and Lawrence grade 4) due to development dysplasia of hip
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety assessment of PRP therapy for development dysplasia of hip
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Usefulness

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	Other
Interventions/Control_1	Using the PRP
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who have symptoms for more than 3 months 2.Patients who have continued pain even after taking NSAIDs for 6 week or more and who can not use NSAIDs for asthma and digestive tract ulcer 3. More than 20 years old 4. Other , patients who the doctor has determined that it is suitable for this clinical study
Key exclusion criteria	1.Patients with a history of hip surgery 2. Patients with abnormal platelet counts in peripheral blood 3.Person who smokes a lot (Brinkmanindex&gt;600) 4. Treatment with anticoagulants(Warfarin) 5. Uncontrolled diabetes mellitus : HbA1c not lower than 9.0% according to latest laboratory data obtained within 14 days before registration 6. Patients with malignancy 7. Patients less than 6 months after onset of cardiac infarction or cerebral infarction 8. Predictive survival period is less than 1 year 9. Active infectious disease (HBV, HCV, HTLV-1, HIV, syphilis) 10.Dialysis patients 11. Compromised host 12.Requiring continued use of oral corticosteroid therapy 13. Less than 20 years old 14.Doctor has determined that it is not suitable for this clinical study
Target sample size	5

Research contact person
Last name of lead principal investigator	1st name Yasuhiro Middle name Last name Honma
Organization	Juntendo Hospital, Juntendo university school of medicine
Division name	Orthopedic Surgery
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Email	yhomma@juntendo.ac.jp

Public contact
1st name of contact person	1st name Yasuhiro Middle name Last name Honma
Organization	Juntendo Hospital, Juntendo university school of medicine
Division name	Orthopedic Surgery
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Homepage URL
Email	yhomma@juntendo.ac.jp

Sponsor
Institute	Juntendo Hospital, Juntendo university school of medicine
Institute
Department

Funding Source
Organization	untendo university
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	Ethical Review Board of Juntendo University Faculty of Medicine
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-3111
Email	rinri@juntendo.ac.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	順天堂大学附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information	2019 Year 03 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	2019 Year 03 Month 14 Day
Date of IRB	2019 Year 03 Month 18 Day
Anticipated trial start date	2019 Year 03 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 03 Month 18 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041004