UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058874 |
|---|---|
| Receipt number | R000067328 |
| Scientific Title | Exploratory study on knee joint dynamics in normal knees and osteoarthritic knees using X-ray fluoroscopic analysis |
| Date of disclosure of the study information | 2025/08/23 |
| Last modified on | 2025/08/23 11:26:56 |
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Basic information
Public title
A study on knee joint movement in normal knees and osteoarthritis of the knee
Acronym
Knee kinematics research
Scientific Title
Exploratory study on knee joint dynamics in normal knees and osteoarthritic knees using X-ray fluoroscopic analysis
Scientific Title:Acronym
Knee kinematics research
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze and compare the knee joint kinematics during weight-bearing movements in normal knees group, mild osteoarthritis of the knee group, and severe osteoarthritis of the knee group using X-ray fluoroscopic kinematic analysis, in order to elucidate the changes in knee joint dynamics associated with the progression of osteoarthritis of the knee and to clarify part of the mechanism underlying the progression of osteoarthritis of the knee.
Basic objectives2
Others
Basic objectives -Others
Treadmill walking, squats, stair climbing, and standing up movements are filmed using an X-ray fluoroscopy device, and dynamic analysis is performed to measure the knee joint's flexion angle, rotation angle, varus/valgus angle, and joint surface inclination angle.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee joint flexion angle, rotation angle, varus/valgus angle, and joint surface inclination angle during treadmill walking, squats, stair climbing, and standing up.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal knee:
Individuals aged 18 years or older and 90 years or younger at the time of informed consent
Individuals with no deformity of the knee joint on plain X-ray images
Individuals who have received adequate explanation regarding participation in this study, demonstrated sufficient understanding, and provided written informed consent of their own free will
Osteoarthritis of the knee:
Individuals diagnosed with osteoarthritis of the knee at Kellgren-Lawrence grade 2 or higher on plain X-ray images
Individuals for whom motion analysis tests are recommended for assessing the condition
Key exclusion criteria
Normal knee:
Individuals requiring surgical treatment for ligament or cartilage damage
Individuals who have undergone surgical treatment affecting alignment, such as fractures or osteotomy
Individuals with systemic diseases affecting the knee joint (e.g., collagen diseases)
Pregnant women or women who may be pregnant
Breastfeeding women
Other patients deemed inappropriate for participation by the principal investigator (or co-investigator)
Osteoarthritis of the knee:
Individuals unable to perform activities of daily living independently
Pregnant women or women who may be pregnant
Breastfeeding women
Other patients deemed inappropriate for participation by the principal investigator (or co-investigator)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Arakawa |
Organization
Saitama Medical University
Division name
Department of orthopaedic surgery
Zip code
350-0495
Address
Morohongo 38, Moroyama-cho, Iruma-gun, Saitama
TEL
049-276-1111
d03sm003@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Arakawa |
Organization
Saitama Medical University
Division name
Department of orthopaedic surgery
Zip code
350-0495
Address
Morohongo 38, Moroyama-cho, Iruma-gun, Saitama
TEL
049-276-1111
Homepage URL
d03sm003@gmail.com
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Takahiro Arakawa
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
Saitama Medical University Ethics Review Committee
Address
Morohongo 38, Moroyama-cho, Iruma-gun, Saitama
Tel
049-276-1111
s_ccr@saitama-med.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 | 08 | Month | 23 | 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 | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Simple X-ray imaging of the knee joint, CT imaging, and MRI imaging if necessary for evaluation of ligaments or cartilage.
X-ray fluoroscopy to capture activities of daily living (knee flexion/extension, treadmill walking, squats, stair climbing, and standing up).
A 14-day observation period (7 days) is required for all procedures except MRI imaging.
Adverse events will be documented in the medical record and case report, including details such as content, onset and resolution timing, severity, management, outcome, severity assessment, dynamic analysis, and any association with CT imaging. Follow-up investigations will be conducted as needed. Severity will be defined as follows: 1) Mild: Condition allowing continued administration without intervention; 2) Moderate: Condition allowing continued administration with some intervention; 3) Severe: Condition requiring discontinuation of administration or indicating discontinuation should be considered.
Management information
Registered date
| 2025 | Year | 08 | Month | 23 | Day |
Last modified on
| 2025 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067328
