UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059087 |
|---|---|
| Receipt number | R000067589 |
| Scientific Title | The Effect of Pelvic Sex Differences on Skeletal Structure and Joint Alignment |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/14 17:45:35 |
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Basic information
Public title
The Effect of Pelvic Sex Differences on Skeletal Structure and Joint Alignment
Acronym
The Effect of Pelvic Sex Differences on Skeletal Structure and Joint Alignment
Scientific Title
The Effect of Pelvic Sex Differences on Skeletal Structure and Joint Alignment
Scientific Title:Acronym
The Effect of Pelvic Sex Differences on Skeletal Structure and Joint Alignment
Region
| Japan |
Condition
Condition
Healthy adult males, healthy adult females
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the influence of pelvic sex differences on joint alignment in healthy adults.
It has been reported that the pelvis exhibits sex differences, and that women tend to have a larger quadriceps angle (the angle formed by connecting the attachment points of the quadriceps muscles). This larger angle may contribute to a greater physiological knee valgus angle. Given that the quadriceps angle originates from the pelvis, which is known to show sex differences, we hypothesized that a larger pelvis would correlate with a greater physiological knee valgus angle.
Furthermore, the incidence of anterior cruciate ligament injuries and knee osteoarthritis is reportedly higher in women. While some reports suggest that physical differences between men and women may explain this sex-based disparity in injury rates, the specific details remain unclear.
Therefore, this study focuses on the alignment between the pelvis and the knee joint to clarify how pelvic sex differences influence knee valgus alignment.
Basic objectives2
Others
Basic objectives -Others
To investigate the effect of pelvic sex differences on knee joint varus alignment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Knee joint external rotation angle in bipedal and one-leg standing posture.
Key secondary outcomes
Interarticular distances (Intervertebral distance, Hip joint distance, Knee joint distance, Ankle joint distance)
Lower limb joint lengths (Thigh length, Lower leg length, Trochanteric length)
Lower limb joint angles (Hip joint, Knee joint, Ankle joint)
Lower leg inclination angle
Pelvic inclination angle
Trunk inclination angle
Center of gravity sway (total trajectory length, rectangle area, maximum sway amplitude front-back/left-right)
Gluteus medius muscle strength
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Twenty-five female and twenty-five male subjects will be enrolled.
The intervention period for each subject will be one day, with a duration of one hour.
Subjects will maintain the following postures for 30 seconds each: bilateral stance, unilateral stance, and unilateral stance (pelvis horizontal position). Information on joint space and joint angles will be collected.
Following this, muscle strength measurements of the hip abductor muscle group will be performed twice for each leg (right and left).
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy adults aged 18 years or older but under 40 years old, affiliated with Gunma University School of Medicine or Gunma University Graduate School of Health Sciences.
2) Individuals capable of maintaining a single-leg stance for 30 seconds or longer.
3) Individuals who consent to participate in the study. Consent is deemed given upon signing the consent form after receiving an explanation using the informed consent document.
4) Posters describing the research outline will be displayed. Individuals who see these posters and voluntarily express their willingness to participate in the study.
Posters will be displayed at the following locations:
- Motion Analysis Laboratory, 6th Floor, Shared Facilities Building, Gunma University School of Medicine
- ADL Training Room, 1st Floor, West Building, Department of Health Sciences, Gunma University School of Medicine
- Prosthetics and Orthotics Room, 1st Floor, West Building, Department of Health Sciences, Gunma University School of Medicine
- Physical Therapy Training Room, 2nd Floor, West Building, Department of Health Sciences, Gunma University School of Medicine
- Classroom 6, 2nd Floor, West Building, Department of Health Sciences, Gunma University School of Medicine
- Classroom 2, 1st Floor, Central Building, Gunma University School of Medicine Recruitment will continue until the end of October 2025. Recruitment will close earlier if the target number of cases is reached before that date.
Key exclusion criteria
1) Individuals with fractures, sprains, or muscle/ligament injuries.
2) Individuals who do not consent to camera filming for three-dimensional motion analysis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Yamaji |
Organization
Gunma University
Division name
Graduate School of Health Sciences, Department of Rehabilitation Studies
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi City, Gunma Prefecture
TEL
027-220-8947
tyamaji@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Yamaji |
Organization
Gunma University
Division name
Graduate School of Health Sciences, Department of Rehabilitation Science
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi City, Gunma Prefecture
TEL
027-220-8947
Homepage URL
tyamaji@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Noting
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
Ethics Review Committee for Medical Research Involving Human Subjects
Address
3-39-15 Showa-machi, Maebashi City, Gunma Prefecture
Tel
027-220-8947
hitotaisho-ciru@ml.gunma-u.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 | 09 | Month | 16 | 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 | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 14 | Day |
Last modified on
| 2025 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067589
