UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063063 |
|---|---|
| Receipt number | R000067502 |
| Scientific Title | Comparative Analysis of Lower Limb Bone morphology in Ankle Osteoarthritis and Its Application to finite element analysis |
| Date of disclosure of the study information | 2026/09/26 |
| Last modified on | 2026/09/26 16:36:38 |
* 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
Comparative Analysis of Lower Limb Bone morphology in Ankle Osteoarthritis and Its Application to finite element analysis
Acronym
Comparative Analysis of Lower Limb Bone morphology in Ankle Osteoarthritis and Its Application to finite element analysis
Scientific Title
Comparative Analysis of Lower Limb Bone morphology in Ankle Osteoarthritis and Its Application to finite element analysis
Scientific Title:Acronym
Comparative Analysis of Lower Limb Bone morphology in Ankle Osteoarthritis and Its Application to finite element analysis
Region
| Japan |
Condition
Condition
ankle osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the three-dimensional lower limb morphology in patients with unilateral varus-type ankle osteoarthritis using CT, and to apply the results to finite element analysis in order to evaluate the biomechanical effects of bone morphology on the ankle joint.
Basic objectives2
Others
Basic objectives -Others
To apply the obtained morphological data to finite element analysis in order to evaluate the effects of bone morphology on intra-articular stress distribution.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in three-dimensional lower-limb bone morphology between patients with unilateral varus ankle osteoarthritis and controls, assessed using CT images obtained for clinical care.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Common criteria:
1. Age 20 years or older.
2. Lower-limb CT performed or scheduled for clinical care.
3. Written informed consent for prospective enrollment. For retrospective use of existing data, public disclosure of study information and an opportunity to opt out, with no refusal of research use.
Ankle osteoarthritis group:
Unilateral varus ankle osteoarthritis of Tanaka-Takakura stage 2-3a, a talar tilt angle of at least 4 degrees, and no evident osteoarthritis in the contralateral hindfoot.
Control group:
No ankle osteoarthritis on either side; CT performed or scheduled for clinical assessment of unilateral lower-limb trauma, including fractures; and no evident history of trauma, deformity, or abnormality on the contralateral side selected for analysis. CT images must be suitable for analysis.
Key exclusion criteria
Common criteria:
1. Evident forefoot disorders, including hallux valgus with an angle of 30 degrees or greater.
2. Pregnancy.
3. Absence of written informed consent for prospective enrollment, or refusal of study participation or research use of data.
Ankle osteoarthritis group:
4. Major foot trauma, paralysis, or previous foot surgery.
5. Marked deformity due to other foot disorders, including rheumatoid arthritis or gout.
6. Bilateral ankle osteoarthritis.
7. Bone diseases other than osteoarthritis.
Control group:
8. A history of trauma involving both lower limbs or feet.
9. Evident foot deformity, previous foot surgery, or chronic foot disease.
10. Evident foot disorders, including rheumatoid arthritis or gout.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Fukushima |
Organization
The Jikei University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku
TEL
03-3433-1111
takumicrisis@gmail.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Fukushima |
Organization
The Jikei University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku
TEL
03-3433-1111
Homepage URL
takumicrisis@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
Institutional Review Board Office, The Jikei University School of Medicine
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
0334441111
takumicrisis@gmail.com
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
東京慈恵会医科大学付属病院（東京都）、東京都慈恵会医科大学附属葛飾医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 26 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study uses lower-limb CT images and clinical information obtained for clinical care. It combines prospective enrollment with written informed consent and retrospective use of existing data with public disclosure and an opportunity to opt out. Three-dimensional bone morphology is compared between patients with unilateral varus ankle osteoarthritis and controls using geometric morphometrics and applied to finite element analysis. No additional CT examinations or extension of the scan range are performed for research purposes.
Management information
Registered date
| 2026 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067502
