UMIN-CTR Clinical Trial

Basic information
Public title	MRI Evaluation after Achilles Tendon Repair by Percutaneous Achilles tendon Repair System(PARS)
Acronym	MRI Evaluation after Achilles Tendon Repair by PARS
Scientific Title	MRI Evaluation after Achilles Tendon Repair by Percutaneous Achilles tendon Repair System(PARS)
Scientific Title:Acronym	MRI Evaluation after Achilles Tendon Repair by PARS
Region	Japan

Condition
Condition	Acute Achilles tendon rupture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we evaluate MRI after achilles tendon repair by Percutaneous Achilles tendon Repair System(PARS).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MRI of Achilles tendon: preoperative, POM1, POM2, POM3
Key secondary outcomes

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	MRI
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	1 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who had achilles tendon repair surgery by PARS within 1 week after injury
Key exclusion criteria	Patients who do not know the situation of the injury Patients who have other trauma except achilles tendon rupture Patients who have SSI after surgery Patients who can not take MRI
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tetsu Middle name Last name Aizawa
Organization	Teine Keijinkai Hospital
Division name	Orthopedic surgery
Zip code	0068555
Address	12-1-40, Maeda1-jo, Teine-ku, Sappro, Hokkaido
TEL	0116818111
Email	aizawa-te@keijinkai.or.jp

Public contact
Name of contact person	1st name Tetsu Middle name Last name Aizawa
Organization	Teine Keijinkai Hospital
Division name	Orthopedic surgery
Zip code	0068555
Address	12-1-40, Maeda1-jo, Teine-ku, Sappro, Hokkaido
TEL	0116818111
Homepage URL
Email	aizawa-te@keijinkai.or.jp

Sponsor
Institute	Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization	Teine Keijinkai Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teine Keijinkai Hospital
Address	12-1-40, Maeda1-jo, Teine-ku, Sappro, Hokkaido
Tel	0116818111
Email	aizawa-te@keijinkai.or.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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 24 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	2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 24 Day
Last modified on	2019 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035357

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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