UMIN-CTR Clinical Trial

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
Last 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
1st 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