UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049395 |
|---|---|
| Receipt number | R000056245 |
| Scientific Title | Evaluation of Patients with Osteoarthritis of the Knee by Ultrasonography |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2026/03/08 17:49:36 |
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Basic information
Public title
Evaluation of Patients with Osteoarthritis of the Knee by Ultrasonography
Acronym
Evaluation of Patients with Osteoarthritis of the Knee by Ultrasonography
Scientific Title
Evaluation of Patients with Osteoarthritis of the Knee by Ultrasonography
Scientific Title:Acronym
Evaluation of Patients with Osteoarthritis of the Knee by Ultrasonography
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To propose a new ultrasonographic (US) quantitative index for the diagnosis of Osteoarthritis of the knee (knee OA) and to validate its diagnostic ability and reproducibility. Furthermore, to perform radiomics analysis of US findings, find features of OA, clarify their diagnostic performance and compare them with the diagnostic performance in the quantitative assessment index in (i). Furthermore, to use deep learning to compare the diagnostic performance of (1) with that of (2).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical severity of knee osteoarthritis
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A physician's final diagnosis of primary osteoarthritis of the knee
Key exclusion criteria
Other than primary knee arthritis.
Re-measurements by the same person are excluded.
Exclusion criteria are,
a) Patients undergoing supine knee radiography,
b) patients after knee arthroplasty,
c) patients after ACL reconstruction,
d) Patients who did not consent to participate in the study,
e) patients for whom data could not be collected due to the absence of a US examiner,
f) patients with lateral type knee OA,
g) patients with secondary knee OA (rheumatoid arthritis, gout/pseudogout, crystal-induced arthritis, idiopathic medial femoral condylar osteonecrosis).
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | TAKEHARU |
| Middle name | |
| Last name | KISO |
Organization
Medical Corporation Seireikai Tachikawa Memorial Hospital
Division name
radiology department
Zip code
3091736
Address
2-12-14 Yakumo, Kasama City, Ibaraki Prefecture
TEL
0296-477-7211
rms5641@yahoo.co.jp
Public contact
Name of contact person
| 1st name | TAKEHARU |
| Middle name | |
| Last name | KISO |
Organization
Medical Corporation Seireikai Tachikawa Memorial Hospital
Division name
radiology department
Zip code
3091736
Address
2-12-14 Yakumo, Kasama City, Ibaraki Prefecture
TEL
0296-477-7211
Homepage URL
rms5641@yahoo.co.jp
Sponsor or person
Institute
Tsukuba International University
Institute
Department
Personal name
Funding Source
Organization
Tsukuba International University
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
Tsukuba International University
Address
6-20-1 Manabe, Tsuchiura-shi, Ibaraki
Tel
029-826-6000
s-kawata@tius.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 | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1016/j.ejro.2025.100649
Number of participants that the trial has enrolled
389
Results
A total of 491 limbs (318 OA, 173 non-OA) were analyzed. A statistical model using SurfaceToVolumeRatio showed specificity 0.98 and sensitivity 0.47. Machine learning showed AUC 0.88 (0.80/0.82) for discriminant analysis and 0.87 (0.81/0.80) for logistic regression. Severity prediction showed AUC 0.92 (0.81/0.85). In CNN analysis, AlexNet improved AUC from 0.87 to 0.89 (p=0.036). ResNet50 showed sensitivity 80% and NPV 68%, and VGG16 showed sensitivity 94% and NPV 96%.
Results date posted
| 2025 | Year | 08 | Month | 30 | Day |
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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who will visit Tachikawa Memorial Hospital from December 1, 2022 to March 31, 2026 for a standing knee X-ray examination. Age 40-85 years.
Criteria for analysis are as follows: Patients with primary osteoarthritis of the knee
Management information
Registered date
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056245
