Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063063) titled 'Comparative Analysis of Lower Limb Bone morphology in Ankle Osteoarthritis and Its Application to finite element analysis' on Sept. 26.
Study Type:
Observational
Primary Sponsor:
Institute - The Jikei University School of Medicine
Condition:
Condition - ankle osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 50
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067502
Disclaimer: Curated by HT Syndication.
