UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058905 |
|---|---|
| Receipt number | R000067040 |
| Scientific Title | Intraoperative Evaluation of Intra-articular Tissue Perfusion Using Indocyanine Green (ICG) Fluorescence in Knee and Shoulder Joint Surgery |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/08/27 07:12:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of blood flow dynamics in intra-articular tissues using indocyanine green fluorescence
Acronym
Study on Joint Blood Flow Using ICG Fluorescence
Scientific Title
Intraoperative Evaluation of Intra-articular Tissue Perfusion Using Indocyanine Green (ICG) Fluorescence in Knee and Shoulder Joint Surgery
Scientific Title:Acronym
ICG-Flow Study
Region
| Japan |
Condition
Condition
Knee joint disorders (ligament injury, meniscus tears, cartilage injury, synovitis, osteoarthritis, etc.) and shoulder joint disorders (rotator cuff tears, shoulder dislocation, etc.)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate intra-articular blood flow during knee and shoulder joint surgery using ICG fluorescence.
Basic objectives2
Others
Basic objectives -Others
To clarify the clinical significance of intra-articular tissue perfusion in relation to tissue healing and postoperative outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of blood flow in intra-articular tissues using ICG fluorescence
Key secondary outcomes
Time required for blood flow visualization and duration, occurrence of allergies caused by ICG, changes in blood flow before and after treatment, and differences according to age.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
During arthroscopic surgery, ICG is administered intravenously and blood flow is visualized using a specialized arthroscope.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals diagnosed with knee joint disorders such as ligament injuries, meniscus tears, cartilage injury, synovitis, osteoarthritis, or shoulder joint disorders such as rotator cuff tears or shoulder dislocation, and who are scheduled to undergo arthroscopic surgery.
Among the above patients, those who have provided written consent.
Among the above patients, those who were 12 years of age or older at the time of consent acquisition.
Includes individuals who have previously undergone knee or shoulder surgery.
Key exclusion criteria
Individuals with a history of hypersensitivity to ICG.
Individuals with a history of iodine hypersensitivity.
Other individuals deemed unsuitable by the principal investigator or co-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tsujii |
Organization
The University of Osaka, Graduate School of Medicine
Division name
Department of Sports Medical Biomechanics
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6210-8439
a-tsujii@ort.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tsujii |
Organization
Graduate School of Medicine, The University of Osaka
Division name
Department of Sports Medical Biomechanics
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
0662108439
Homepage URL
a-tsujii@ort.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
None
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
The University of Osaka, Graduate School of Medicine
Address
2-2 Yamadaoka, Suita, Osaka
Tel
0662108439
a-tsujii@ort.med.osaka-u.ac.jp
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
| 2025 | Year | 09 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067040
