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.
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
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)
Parallel
Training intervention
BehavioralPersonalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.
Primary Endpoint
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.
Secondary Endpoint: Cartilage Thickness
Quantitative magnetic resonance imaging measurement of cartilage thickness, expressed in millimeters (mm), across predefined articular sub-regions of the knee.
Secondary Endpoint: Cartilage Volume
Quantitative magnetic resonance imaging measurement of cartilage volume, expressed in cubic millimeters (mm³), across predefined articular sub-regions of the knee.
Secondary Endpoint: Cartilage Composition
Quantitative magnetic resonance imaging measurement of cartilage composition using laminar T2 relaxation time, expressed in milliseconds (ms), reflecting cartilage water content and collagen organization across predefined articular sub-regions of the knee.
Secondary Endpoint: Meniscus Position
Quantitative magnetic resonance imaging measurement of meniscus extrusion, expressed in millimeters (mm), defined as the distance the meniscus extends beyond the edge of the tibial plateau.
Exploratory Endpoint: Biomarkers of Joint Tissue Remodeling
Circulating and synovial fluid markers of joint tissue remodeling (e.g., CTX-I, CTX-II, PRO-C2, C1M) will be measured using validated immunoassays with detection limits in the nanogram-per-milliliter (ng/mL) range.
Exploratory Endpoint: Inflammatory Cytokines
Plasma or serum concentrations of inflammatory cytokines and soluble mediators (e.g., TNF-α, G-CSF, IFN-γ, IL-6) will be determined using validated multiplex immunoassays with detection limits in the picogramm-per-milliliter (pg/mL) range.
Exploratory Endpoint: Cellular Biomarkers
Immune cell subpopulations in peripheral blood and synovial fluid are analyzed by standardized multiparameter flow cytometry for basic phenotyping of T cells, B cells and myeloid cell populations and reported either as absolute or relative cell count.
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