Status:
NOT_YET_RECRUITING
Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Osteoarthritis (OA) of the Knee
ACL Reconstruction
Eligibility:
All Genders
18-50 years
Phase:
NA
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. Cur...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Underwent anterior cruciate ligament reconstruction (ACLR) due to an acute knee injury in the past 12 months
- ACLR patients with aberrant gait profiles who exhibit all three aberrant characteristics (knee flexion angle, knee flexion moment, and knee adduction moment)
Exclusion
- Previous trauma or surgery (other than ACLR) to any weight-bearing joint,
- Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
- 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;
- 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;
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06596824
Start Date
October 1 2024
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117