Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060720) titled 'Longitudinal Study of Factors Contributing to the Development of Osgood-Schlatter Disease in Growing Soccer Players' on March 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Gunma University
Condition:
Condition - Osgood-Schlatter Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 12
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 Size - 75
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 18 Day
Anticipated trial start date - 2026 Year 03 Month 01 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=R000069468
Disclaimer: Curated by HT Syndication.