UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036496
Receipt number R000041585
Scientific Title Effectiveness and Safety of Platelet-Rich Plasma Injection for Achilles Tendon Rupture Repair
Date of disclosure of the study information 2019/04/13
Last modified on 2019/04/13 10:03:50

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Basic information

Public title

Effectiveness and Safety of Platelet-Rich Plasma Injection for Achilles Tendon Rupture Repair

Acronym

PRP for ATRR

Scientific Title

Effectiveness and Safety of Platelet-Rich Plasma Injection for Achilles Tendon Rupture Repair

Scientific Title:Acronym

PRP for ATRR

Region

Japan


Condition

Condition

Achilles tendon rupture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effectiveness and safety of PRP for Achilles tendon rupture repair

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bilateral heel rise test

Key secondary outcomes

1)Single heel rise test
2)clinical score
3)MRI findings


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Injection of PRP to suture site of Achilles tendon 3 weeks after surgery.

Interventions/Control_2

Injection of saline to suture site of Achilles tendon 3 weeks after surgery.

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

30 years-old <=

Age-upper limit

59 years-old >=

Gender

Male

Key inclusion criteria

1) A patient with Achilles tendon rupture diagnosed based on physical and MRI findings
2) Primary injury
3) Single leg injury
4) Patients who would like to receive surgery

Key exclusion criteria

1) A patient who does not agree with non-smoking
2) Diabetes, malignant cancer, and autoimmune disease

Target sample size

14


Research contact person

Name of lead principal investigator

1st name Youichi
Middle name
Last name Yasui

Organization

Teikyo University School of Medicine

Division name

Orthopaedic department

Zip code

173-8605

Address

2-11-1, Kaga, Itabashi, Tokyo

TEL

03-3964-4097

Email

youichi_yasui_41@yahoo.co.jp


Public contact

Name of contact person

1st name Youichi
Middle name
Last name Yasui

Organization

Teikyo University School of Medicine

Division name

Orthopaedic department

Zip code

173-8605

Address

2-11-1, Kaga, Itabashi, Tokyo

TEL

03-3964-4097

Homepage URL


Email

youichi_yasui_41@yahoo.co.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Teikyo 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

Teikyo University Review Board

Address

2-11-1, Kaga, Itabashi, Tokyo

Tel

03-3964-7256

Email

turb-office@teikyo-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

CNCD3-30001

Org. issuing International ID_1

CONCIDE

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 13 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

2018 Year 10 Month 16 Day

Date of IRB

2018 Year 10 Month 16 Day

Anticipated trial start date

2018 Year 10 Month 16 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 04 Month 13 Day

Last modified on

2019 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041585


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name