UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060720 |
|---|---|
| Receipt number | R000069468 |
| Scientific Title | Longitudinal Study of Factors Contributing to the Development of Osgood-Schlatter Disease in Growing Soccer Players |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/21 03:16:39 |
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Basic information
Public title
Longitudinal Study of Factors Contributing to the Development of Osgood-Schlatter Disease in Growing Soccer Players
Acronym
Longitudinal Study of Factors Contributing to the Development of Osgood-Schlatter Disease in Growing Soccer Players
Scientific Title
Longitudinal Study of Factors Contributing to the Development of Osgood-Schlatter Disease in Growing Soccer Players
Scientific Title:Acronym
Longitudinal Study of Factors Contributing to the Development of Osgood-Schlatter Disease in Growing Soccer Players
Region
| Japan |
Condition
Condition
Osgood-Schlatter Disease
Classification by specialty
| Orthopedics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the factors contributing to the onset of osteochondritis dissecans (OCD) in adolescent soccer players. This will be achieved by using ultrasound imaging to assess the condition of the tibial tuberosity, deep infrapatellar bursa, and patellar tendon, while also longitudinally observing the muscle thickness and echogenicity of each quadriceps femoris muscle (rectus femoris, vastus intermedius, vastus medialis, vastus lateralis). The study will also examine the relationship between these findings and clinical observations.
Basic objectives2
Others
Basic objectives -Others
This study is an intervention study targeting adolescent soccer players. It longitudinally evaluates exercise, physical characteristics, and ultrasound imaging findings to investigate the relationship between body composition, muscle function, flexibility, performance, and ultrasound-measured morphology and muscle thickness/brightness of the tibial tuberosity, patellar tendon, and quadriceps femoris muscle, and the onset of Osgood-Schlatter disease. muscle echogenicity, and the onset of Osgood-Schlatter disease, thereby elucidating its causative factors.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of Osgood-Schlatter disease
Key secondary outcomes
Height, Weight, BMI, Body Fat Percentage, Visceral Fat Level, Skeletal Muscle Mass Index (STAR), Thigh Quadriceps Muscle Thickness (Rectus Femoris, Vastus Intermedius, Vastus Medialis, Vastus Lateralis), Thigh Quadriceps Muscle Brightness (Rectus Femoris, Vastus Intermedius, Vastus Medialis, Vastus Lateralis), Knee Extension Strength, Heel-Buttock Distance (HBD), Maximum dorsiflexion angle (DFA) of the weight-bearing ankle, Single Hop Test (SHT), One-Legged Stand Test, age, years playing soccer, years of sports experience, weekly practice hours, weekly practice days, monthly number of matches, presence/absence of cool-down, cool-down duration
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
For adolescent soccer players, we will perform ultrasound imaging to evaluate muscle thickness and echogenicity of the quadriceps femoris (rectus femoris, vastus intermedius, vastus medialis, vastus lateralis), as well as observe the tibial tuberosity, patellar tendon, and deep infrapatellar bursa. Additionally, body composition measurements, knee extension strength testing, flexibility assessments, athletic performance tests, and questionnaires regarding sport-specific characteristics will be conducted.Following the initial evaluation, a 6-month follow-up period will be established, with the same musculoskeletal assessments repeated at 6 months.
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
| 12 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Male junior high school students belonging to soccer club teams within Gunma Prefecture.
(2) Individuals from whom consent can be obtained through written and oral explanations.
(3) Individuals for whom consent has also been obtained from their legal representatives (guardians).
Key exclusion criteria
Exclude any individual who meets any one of the following three criteria:
(1) Individuals currently diagnosed with orthopedic conditions affecting the upper or lower limbs or trunk, for which a physician has restricted physical activity.
(2) Individuals with a history of hip or knee joint disease (including surgical history) that may potentially affect knee extension strength (i.e., individuals unable to sufficiently exert knee extension strength).
(3) Individuals who do not provide consent, either personally or through a proxy, after receiving the written explanation and verbal briefing.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tajika |
Organization
Graduate School of Gunma University
Division name
Graduate School of Health Sciences, Rehabilitation Studies
Zip code
371-8514
Address
3-39-22 Showa-cho, Maebashi City, Gunma Prefecture
TEL
027-220-8945
tajika@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tajika |
Organization
Graduate School of Gunma University
Division name
Graduate School of Health Sciences, Rehabilitation Studies
Zip code
371-8514
Address
3-39-22 Showa-cho, Maebashi City, Gunma Prefecture
TEL
027-220-8945
Homepage URL
tajika@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Gunma University Medical Research Ethics Review Committee for Human Subjects
Address
3-39-15 Showa-cho, Maebashi City, Gunma Prefecture
Tel
027-220-8740
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
| 2026 | Year | 03 | Month | 01 | 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
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | 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
Management information
Registered date
| 2026 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069468
