UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036243
Receipt number 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 10:18:09

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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 or person

Institute

Juntendo Hospital, Juntendo university school of medicine

Institute

Department

Personal name



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

Value
https://center6.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