NCT06596824 Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
| NCT ID | NCT06596824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Osteoarthritis (OA) of the Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06596824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Osteoarthritis (OA) of the Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06596824 currently recruiting?
Yes, NCT06596824 is actively recruiting participants. Contact the research team at tobias.winkler@charite.de for enrollment information.
Where is the NCT06596824 trial being conducted?
This trial is being conducted at Berlin, Germany, Berlin, Germany.
Who is sponsoring the NCT06596824 clinical trial?
NCT06596824 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 60 participants.