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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027830
Receipt No. R000031886
Scientific Title Visual evaluation of blood flow in meniscus and ligament
Date of disclosure of the study information 2017/08/01
Last modified on 2017/06/20

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Basic information
Public title Visual evaluation of blood flow in meniscus and ligament
Acronym Visual evaluation of blood flow in meniscus and ligament
Scientific Title Visual evaluation of blood flow in meniscus and ligament
Scientific Title:Acronym Visual evaluation of blood flow in meniscus and ligament
Region
Japan

Condition
Condition gonarthrosis, anterior cruciate ligament injury, posterior cruciate ligament injury, meniscus injury, discoid meniscus
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the blood flow of the meniscal and ligament using indocyanine green (ICG) in knee joint surgery.
Basic objectives2 Others
Basic objectives -Others We evaluate the difference of blood flow between normal, degenerative, ruptured tissues.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate the difference in blood flow depending on the degree of rupture type (horizontal tear, transverse tract, longitudinal fracture) and ligament injury (complete rupture, incomplete rupture), degeneration degree. For cases in which postoperative remodeloscopy was possible, blood flow evaluation was performed.
Key secondary outcomes Clinical assessment, image evaluation (Xp ,CT,MRI), age, sex, body mass index, blood pressure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 We do the intravenous administration of indocyanine Green to evaluate blood flow during surgery. Indocyanine Greenare administered only one day at the time of surgery.
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
0 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria We do prospective studies in patients to perform under direct vision surgery or knee arthroscopy at our institution.
Key exclusion criteria 1:Patients with a history of hypersensitivity to components of the ICG
2:Patients with a history of iodine hypersensitivity
3:Patients who did not agree to participate in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobunao Doi
Organization Fukuoka University Hospital
Division name Orthopedics
Zip code
Address 814-0180,7-45-1, Nanakuma, Jonan-ku,Fukuoka-shi,Fukuoka
TEL 092-801-1011
Email doi03121028@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobunao Doi
Organization Fukuoka University Hospital
Division name Orthopedics
Zip code
Address 814-0180,7-45-1, Nanakuma, Jonan-ku,Fukuoka-shi,Fukuoka
TEL 092-801-1011
Homepage URL
Email doi03121028@gmail.com

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization Fukuoka 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
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
2017 Year 08 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
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 13 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
2017 Year 06 Month 20 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031886

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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