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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017312
Receipt No. R000020089
Scientific Title A study in healing process of tendon-to-bone insertion - microvascularity anlysis -
Date of disclosure of the study information 2015/04/28
Last modified on 2015/04/28

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Basic information
Public title A study in healing process of tendon-to-bone insertion - microvascularity anlysis -
Acronym A study in healing process of tendon-to-bone insertion
Scientific Title A study in healing process of tendon-to-bone insertion - microvascularity anlysis -
Scientific Title:Acronym A study in healing process of tendon-to-bone insertion
Region
Japan

Condition
Condition rotator cuff tear
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify microvascularity in the intact or ruptured cuff insertion using contrast enhanced ultrasound
Basic objectives2 Others
Basic objectives -Others To investigate healing process of tendon-to-bone insertion
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Comparison in microvascularity between intact and ruptured tendon
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Age
Interventions/Control_2 Rupture
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. small^midiam supraspinatus tear
2. Ipilateral tear
3. From 30 to 80 years old
4. Informed concent
Key exclusion criteria 1. Drug Allergy
2. Egg allergy
3. Shunt in heart or lung
4. Severe heart disease
5. Severe lung disease
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Minami
Organization Hokkaido University Graduate School of Medicine
Division name Dept. of Orthopaedic Surgery
Zip code
Address Kita 15 Nishi 5, Sapporo, Hokkaido
TEL 011-706-5937
Email a-minami@med.hokdai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadanao Funakoshi
Organization Hokkaido University Graduate School of Medicine
Division name Dept. of Orthopaedic Surgery
Zip code
Address Kita 15 Nishi 5, Sapporo, Hokkaido
TEL 011-706-5937
Homepage URL
Email t-funa@med.hokudai.ac.jp

Sponsor
Institute Dept. of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Orthopaedics and Traumatology Fundation
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2008 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 17 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
2015 Year 04 Month 28 Day
Last modified on
2015 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020089

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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