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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036243
Receipt No. R000041003
Scientific Title Clinical study on safety assessment of PRP therapy for iliopsoas impingement after total hip arthroplasty
Date of disclosure of the study information 2019/03/18
Last modified on 2019/03/18

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Basic information
Public title Clinical study on safety assessment of
PRP therapy for iliopsoas impingement after total hip arthroplasty
Acronym Clinical study on safety assessment of
PRP therapy for iliopsoas impingement after total hip arthroplasty
Scientific Title Clinical study on safety assessment of
PRP therapy for iliopsoas impingement after total hip arthroplasty
Scientific Title:Acronym Clinical study on safety assessment of
PRP therapy for iliopsoas impingement after total hip arthroplasty
Region
Japan

Condition
Condition Patients who is diagnosed iliopsoas impingement after total hip arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety assessment of PRP therapy for iliopsoas impingement
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 abnormal platelet counts in peripheral blood
2. Person who smokes a lot(Brinkmanindex&gt;600)
3. Treatment with anticoagulants(Warfarin)
4. Uncontrolled diabetes mellitus :HbA1c not lower than 9.0% according to latest laboratory data obtained within 14 days before registration
5. Patients with malignancy
6. Patients less than 6 months after onset of cardiac infarction or cerebral infarction
7. Predictive survival period is less than 1 year
8.Active infectious disease (HBV, HCV, HTLV-1, HIV, syphilis)
9.Dialysis patients
10. Compromised host
11. Requiring continued use of oral corticosteroid therapy
12. Less than 20 years old
13. Doctor has determined that it is not suitable for this clinical study
Target sample size 5

Research contact person
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
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 Juntendo 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=R000041003

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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