Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
Training intervention: Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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 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;
Primary outcome measure(s)
Primary Endpoint — at 6-month follow-up visit Restoration of normal knee angle and moment patterns during walking at 6-month follow-up (compared to normative data), as determined by a machine learning-derived gait index.
Trial sites (2)
Facility
City
Region
Status
Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics
Berlin
Germany
Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Germany
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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