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New treatment option for Osteoarthritis (OA) of the Knee
Official title Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
ClinicalTrials.gov ID: NCT06596824
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- Signed written informed consent
- Adult people 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
You likely can't join if
- 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;
See the full eligibility criteria
- Signed written informed consent
- Adult people 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)
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.