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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022600
Receipt No. R000026050
Scientific Title The study of tissue regeneration and promotion of heeling for meniscal tear and regenerative meniscus.
Date of disclosure of the study information 2016/07/01
Last modified on 2019/06/07

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Basic information
Public title The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Acronym The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Scientific Title The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Scientific Title:Acronym The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Region
Japan

Condition
Condition meniscal tear
degenerative meniscus
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to improve symptoms
by promoting blood flow by physical
stimulation to the meniscus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence or absence of improvement in symptoms with a focus on IKDC scor
Key secondary outcomes The presence or absence of improvement in MRI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Control
Interventions/Control_2 Interventions
Extracorporeal shock wave irradiation group
Start the irradiation at 0.01mj / mm2 with no anesthesia using DUOLITH SD1(STORTS Medical CO,. Ltd.) Gradually energy while irradiating the 500 shots continue up until 0.25mj / mm2, it is irradiated with 2000 shots. This is enforced three times every other week.

Interventions/Control_3 Interventions
Ultrasound irradiation group
3 weeks irradiation every day for 20 minutes of ultrasound using SAFHS 4000J(TEIJIN Pharma CO,. Ltd.)

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 Over 20 year old patient diagnosed with meniscal tear in MRI.

2 Osteoarthritis of knee patient diagnosed Kellgren-Laurence classification 1-2 with meniscal degeneration in MRI.

Key exclusion criteria 1 cases with underlying disease such as rheumatoid arthritis, traumatic knee osteoarthritis, psedogout.
2 cases treated with anti-inflammatory analgesic and opioid, Neurotropin within 2 weeks prior to start of this study.
3 cases treated with steroid oral and intra-articular injection within 4 weeks prior to start of this study.
4 cases participated in other clinical study within the start of this study before 16 weeks.
5 cases with heart disease, liver dysfunction, kidney dysfunction, mental illness to be a clinical problem.

Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Deie
Organization Aichi Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-1 Karimata, Yazako, Nagakute-shi, Aichi, Japan
TEL 0561-62-3311
Email snm@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Machiko Akao
Organization Aichi Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-1 Karimata, Yazako, Nagakute-shi, Aichi, Japan
TEL 0561-62-3311
Homepage URL
Email akao@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 愛知医科大学病院 Aichi Medical University Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
2016 Year 05 Month 13 Day
Date of IRB
2016 Year 05 Month 13 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 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
2016 Year 06 Month 04 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026050

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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