Clinical trial NCT06596824: Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
Official title: Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
ACL Reconstruction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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\&#39;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
* 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 \&amp;lt; 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;

Primary outcomes:
measure: Primary Endpoint
timeFrame: at 6-month follow-up visit
Secondary outcomes:
measure: Secondary endpoints measure the potential magnetic resonance imaging (MRI) changes from BL for the following parameters:
timeFrame: Baseline, 6, and 36 months followup visits
Other outcomes:
measure: Exploratory Endpoints measure the potential changes from BL for the following parameters:
timeFrame: Baseline, 6, and 36 months follow-up visits
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References: