Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Osteoarthritis (OA) of the Knee; ACL Reconstruction

• Registration Number: NCT06596824
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Signed written informed consent<br><br> - Underwent anterior cruciate ligament reconstruction (ACLR) due to an acute knee<br> injury in the past 12 months<br><br> - ACLR patients with aberrant gait profiles who exhibit all three aberrant<br> characteristics (knee flexion angle, knee flexion moment, and knee adduction moment)<br><br>Exclusion Criteria:<br><br> - Previous trauma or surgery (other than ACLR) to any weight-bearing joint,<br><br> - Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or<br> more (standing AP x-ray)<br><br> - Body mass index = 30 kg/m2;<br><br> - Inflammatory arthropathies;<br><br> - Immunosuppression due to illness or medication;<br><br> - Sepsis or hemostasis disorders;<br><br> - Severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative<br> colitis, Crohn's disease, etc.);<br><br> - Having malignancy and undergoing treatment including chemotherapy, radiotherapy, or<br> immunotherapy;<br><br> - Unable to freely give their informed consent (e.g., individuals under legal<br> guardianship).<br><br> - Currently enrolled in or has not yet completed a period of at least 5 times as the<br> half-life time of the drug used in the previous trial since ending other<br> investigational device or drug trial(s)<br><br> - Patients who are dependent on the sponsor, investigator, or study site;<br><br> - Pregnant or breast-feeding women or women of childbearing potential not protected by<br> an effective contraceptive method of birth control (defined as pearl index &lt;<br> 1);<br><br> - Any form of substance abuse, psychiatric disorder, or other condition that, in the<br> opinion of the Investigator, may invalidate communication with the Investigator<br> and/or designated study personnel;<br><br> - Patients who are committed to an institution by virtue of an order issued by either<br> the judicial or the administrative authorities;

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints measure the potential magnetic resonance imaging (MRI) changes from BL for the following parameters: