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| ID | Type | Description | Link |
|---|---|---|---|
| 101095635 | Other Grant/Funding Number | Horizon-Programm der EU |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The treatment group | Experimental | In addition to the standard-of-care physiotherapy program, the treatment group will additionally receive a training intervention utilizing sensor-based technology that provides 3D avatar training, supported by an accompanying app, to deliver personalized exercise regimens. This intervention aims to correct the pathological knee movement and loading patterns that exacerbate joint inflammation and contribute to the development of knee OA. |
|
| the control group | No Intervention | Standard-of-care physiotherapy program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training intervention | Behavioral | Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 6-month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: Cartilage Thickness | Quantitative magnetic resonance imaging measurement of cartilage thickness, expressed in millimeters (mm), across predefined articular sub-regions of the knee. | Baseline, 6, and 36 months follow-up visits |
| Secondary Endpoint: Cartilage Volume |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6, and 36 months follow-up visits |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Winkler, Prof. Dr.med. | Contact | +49 30 450 559084 | tobias.winkler@charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics | Recruiting | Berlin | 10117 | Germany | ||
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Quantitative magnetic resonance imaging measurement of cartilage volume, expressed in cubic millimeters (mm³), across predefined articular sub-regions of the knee. |
| Baseline, 6, and 36 months follow-up visits |
| 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. | Baseline, 6, and 36 months follow-up visits |
| 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. | Baseline, 6, and 36 months follow-up visits |
| Secondary Endpoint: Hoffa Synovitis | Quantitative magnetic resonance imaging measurement of Hoffa synovitis, expressed as a signal distribution pattern (dimensionless) within the infrapatellar (Hoffa's fat pad) region. | Baseline, 6, and 36 months follow-up visits |
| Secondary Endpoint: Effusion Synovitis | Quantitative magnetic resonance imaging measurement of joint effusion and synovitis, expressed as synovial fluid volume in cubic millimeters (mm³). | Baseline, 6, and 36 months follow-up visits |
| Secondary Endpoint: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) | Semi-quantitative assessment of structural pathology using the Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS), where scores range from 0 (no cartilage damage) to 3 (severe cartilage damage), with higher scores indicating greater pathology, across fourteen articular sub-regions. | Baseline, 6, and 36 months follow-up visits |
| 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. |
| Baseline, 6, and 36 months follow-up visits |
| 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. | Baseline, 6, and 36 months follow-up visits |
| Charité - Universitätsmedizin Berlin |
| Recruiting |
| Berlin |
| 10117 |
| Germany |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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