Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Move… (NCT06596824) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
Germany60 participantsStarted 2024-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 end…