S83.53
Conditions
Interventions
Group 1: Individuals aged 18 to 50 years who have undergone single-bundle ACL reconstruction within 6 months of a unilateral ACL injury and who complete a full baseline assessment between 8 and 12 wee
Sponsors
Universitätsmedizin Berlin, Julius Wolff Institute and Berlin Institute of Health Center for Regenerative Therapies (BCRT)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Adult subjects 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
Exclusion criteria
Exclusion criteria: - Significant trauma to any weight-bearing joint in the 12 months prior to the start of the study (excluding the ACL injury in question) - Past surgery to the study knee (excluding the ACLR in question) - Inflammatory arthropathies - Signs of knee OA as defined by a score of =2 on the OARSI Joint Space Narrowing grading scale (measured on X-ray acquired as part of routine care prior to ACLR) - 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 - 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.) - 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 - 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) - Unable to freely give their informed consent (e.g., individuals under legal guardianship) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Restoration of normal knee angle and moment patterns during walking at 6-month follow-up (compared to normative data), as determined by a machine learning-derived gait index. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Quantitative measures of cartilage composition, morphology, and synovitis via magnetic resonance imaging (MRI). - Semi-quantitative assessment of structural pathology using the MRI Osteoarthritis Knee Score. Exploratory Endpoints: - Analysis of cellular and molecular biomarkers from blood/serum, urine, and synovial fluid samples, used solely for exploratory purposes without established study endpoints. | — |
Countries
Germany
Contacts
Public ContactTobias Winkler
Charité – Universitätsmedizin Berlin
Outcome results
None listed