UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027830 |
|---|---|
| Receipt number | 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 12:05:49 |
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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
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
doi03121028@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031886
