Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction

Официальное название

Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)

Обзор

Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don\'t fully prevent OA from developing. This study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. The goal is to reduce joint inflammation and prevent the development of OA in patients who have had knee surgery.

Вмешательства

• Поведенческое Training intervention
  Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.

Первичные конечные точки

• Primary Endpoint [Срок оценки: at 6-month follow-up visit]

Вторичные конечные точки (7)

• Secondary Endpoint: Cartilage Thickness [Срок оценки: Baseline, 6, and 36 months follow-up visits]
• Secondary Endpoint: Cartilage Volume [Срок оценки: Baseline, 6, and 36 months follow-up visits]
• Secondary Endpoint: Cartilage Composition [Срок оценки: Baseline, 6, and 36 months follow-up visits]
• Secondary Endpoint: Meniscus Position [Срок оценки: Baseline, 6, and 36 months follow-up visits]
• Secondary Endpoint: Hoffa Synovitis [Срок оценки: Baseline, 6, and 36 months follow-up visits]
• Secondary Endpoint: Effusion Synovitis [Срок оценки: Baseline, 6, and 36 months follow-up visits]
• Secondary Endpoint: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) [Срок оценки: Baseline, 6, and 36 months follow-up visits]

Критерии участия

Критерии включения

• Signed written informed consent
• Adult subjects between 18 to 50 years old at the time of screening
• Primary ACL reconstruction within a maximum of 6 months after a unilateral ACL injury
• Complete baseline assessment between 8 and 12 weeks after ACL reconstruction

Критерии исключения

• Significant trauma to a weight-bearing joint within 12 months prior to study initiation (excluding the ACL injury)
• Previous surgeries on the study knee (except for the ACL reconstruction)
• Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
• Physical activity level: Tegner activity score before injury of 0-2 (very low activity) or 8-10 (very high activity)
• Body mass index ≥ 30 kg/m2;
• Inflammatory arthropathies;
• Immunosuppression due to illness or medication;
• Sepsis or hemostasis disorders;
• Severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.);
• Having malignancy and undergoing treatment including chemotherapy, radiotherapy, or immunotherapy;
• Contraindications for MRI, including pacemakers, defibrillators, metal implants, pregnancy, sensorineural hearing loss above 30 dB, tinnitus and claustrophobia
• Unable to freely give their informed consent (e.g., individuals under legal guardianship).
• Currently enrolled in or has not yet completed a period of at least 5 times as the half-life time of the drug used in the previous trial since ending other investigational device or drug trial(s)
• Patients who are dependent on the sponsor, investigator, or study site;
• Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1);
• Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel;
• Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Германия · 2 центра

• Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics — Berlin
• Charité - Universitätsmedizin Berlin — Berlin

Идентификаторы

NCT: NCT06596824 · PROTO-WP4 · 101095635

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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