Osteoarthritis (OA) of the Knee, ACL Reconstruction
Conditions
Brief 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.
Interventions
BEHAVIORALTraining intervention
Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint: Cartilage Thickness | Baseline, 6, and 36 months follow-up visits | Quantitative magnetic resonance imaging measurement of cartilage thickness, expressed in millimeters (mm), across predefined articular sub-regions of the knee. |
| Secondary Endpoint: Cartilage Volume | Baseline, 6, and 36 months follow-up visits | 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 | Baseline, 6, and 36 months follow-up visits | 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 | Baseline, 6, and 36 months follow-up visits | 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. |
| Secondary Endpoint: Hoffa Synovitis | Baseline, 6, and 36 months follow-up visits | Quantitative magnetic resonance imaging measurement of Hoffa synovitis, expressed as a signal distribution pattern (dimensionless) within the infrapatellar (Hoffa's fat pad) region. |
| Secondary Endpoint: Effusion Synovitis | Baseline, 6, and 36 months follow-up visits | Quantitative magnetic resonance imaging measurement of joint effusion and synovitis, expressed as synovial fluid volume in cubic millimeters (mm³). |
| Secondary Endpoint: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) | Baseline, 6, and 36 months follow-up visits | 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. |
Countries
Germany
Contacts
CONTACTWinkler, Prof. Dr.med.
Outcome results
None listed