UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017349 |
|---|---|
| Receipt number | R000020106 |
| Scientific Title | The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis - |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2016/06/14 21:27:56 |
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Basic information
Public title
The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis -
Acronym
The effect of synovium for tendon-to-bone insertion healing
Scientific Title
The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis -
Scientific Title:Acronym
The effect of synovium for tendon-to-bone insertion healing
Region
| Japan |
Condition
Condition
rotator cuff tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of synovium for tendon-to-bone insertion healing in the patient with rotator cuff tear using contrast enhanced ultrasound.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
microvascular pattern in tendon-to-bone insertion and synovium after rotator cuff repair.
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Arthroscopic rotator cuff tear
Interventions/Control_2
Opne rotator cuff tear
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. small to midium size rotator cuff tear
2. Over 35 years old
3. 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
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadanao Funakoshi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic surgery
Zip code
Address
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5937
tfunakoshi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Urita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedc surgery
Zip code
Address
Kita14 Nishi5, Kita-ku, Sapporo
TEL
011-706-5937
Homepage URL
uriboh@zg7.so-net.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
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
Address
Tel
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 | 05 | Month | 01 | 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
| 2010 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | 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 | 30 | Day |
Last modified on
| 2016 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020106
