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RECRUITING

NCT06596824

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

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-01

Completion Date

2027-12-31

Last Updated

2026-03-02

Healthy Volunteers

Conditions

Osteoarthritis (OA) of the Knee ACL Reconstruction

Interventions

BEHAVIORAL

Training intervention

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

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;

Locations (2)

Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics

Berlin, Germany

Charité - Universitätsmedizin Berlin