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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036496
Receipt No. 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

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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
Institute Teikyo University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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