UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048392 |
|---|---|
| Receipt number | R000055161 |
| Scientific Title | Evaluation of meniscus with novel probing sensor |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2025/01/16 09:05:25 |
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Basic information
Public title
Evaluation of meniscus with novel probing sensor
Acronym
Evaluation of meniscus with probing sensor
Scientific Title
Evaluation of meniscus with novel probing sensor
Scientific Title:Acronym
Evaluation of meniscus with probing sensor
Region
| Japan |
Condition
Condition
meniscus injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cartilage, meniscus and ligament injury with probing sensor.
Basic objectives2
Others
Basic objectives -Others
disease analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of probing value between disease and normal meniscus, cartilage and ligament
Key secondary outcomes
To find out the occult disease in the knee joint
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who receive knee arthroscopy
Key exclusion criteria
patient who suffered rheumatoid arthritis or infection
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Otsuki |
| Middle name | |
| Last name | Shuhei |
Organization
Osaka Medical and Pharmaceutical University
Division name
Orthipedic Surgery
Zip code
569-8686
Address
2-7 Daigakumachi Takatsuki Osaka JAPAN
TEL
072-683-1221
shuhei.otsuki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Otsuki |
| Middle name | |
| Last name | Shuhei |
Organization
Osaka Medical and Pharmaceutical University
Division name
Orthipedic Surgery
Zip code
569-8686
Address
2-7 Daigakumachi Takatsuki Osaka JAPAN
TEL
072-683-1221
Homepage URL
shuhei.otsuki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical 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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi Takatsuki Osaka JAPAN
Tel
072-683-1221
shuhei.otsuki@ompu.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
| 2022 | Year | 07 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
To observe the value of probing sensor from meniscus, cartilage, and ligament injury.
Management information
Registered date
| 2022 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055161
