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

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new 12-week exercise program aimed at helping people who have had surgery for a knee injury, specifically those who had their anterior cruciate ligament (ACL) reconstructed. The program uses a special sensor system to improve how the knee moves, which could help reduce inflammation and prevent knee osteoarthritis (OA) from developing. Osteoarthritis is a condition that causes pain and stiffness in the joints, often leading to long-term problems after injuries.

To take part in this study, participants should be between the ages of 18 and 62 and must have undergone ACL reconstruction in the past year. They should also show specific movement issues related to their knee. However, certain conditions, such as previous surgeries on other weight-bearing joints, signs of existing OA, or significant health problems, may prevent someone from joining the trial. Those who qualify can expect to participate in this innovative exercise program and contribute to important research on knee health after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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;