About this trial
Knee osteoarthritis is a complex condition, and selecting effective non-drug treatments like orthoses or exercise is often difficult and imprecise. This study will follow individuals with early-stage knee osteoarthritis or previous anterior cruciate ligament injury to develop computational models that predict cartilage degeneration and pain over time. The models will integrate data from medical imaging, movement analysis, muscle strength testing, pain assessments, questionnaires, and biomarkers to improve personalized treatment planning.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ACL injury within the last year and planned for ACL reconstruction at inclusion
Informed consent form signed
Disqualifiers
Previous knee surgery before current knee trauma.
Severe ischemic or neurological sequelae.
BMI above 32.
Clinically significant joint disease (inflammatory or degenerative) to other joints than the ACL injured knee (according to the clinician).
Trial population
Knee OA Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers. ACL Reconstruction Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression. ACL No Reconstruction Participants with anterior cruciate ligament injury who did not undergo reconstructive surgery. Observed over time for cartilage degeneration and symptoms. Control for Knee OA Group Age- and sex-matched participants with no clinical or imaging signs of knee osteoarthritis. Serve as controls for the Knee OA group. Control for ACL Reconstruction Group Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls. Control for ACL No Reconstruction Group Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
6
Trial groupsSee each trial group below.
Trial outcomes
Primary outcomes
Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging
Person-specific 3T MRI scans will be used to measure changes in knee cartilage, including T1ρ and T2 relaxation times and 3D geometry, as indicators of cartilage biochemical composition and structural integrity. Analyses will be used for predictive computational modeling of cartilage degeneration.
Secondary outcomes
Knee Pain Intensity (Visual Analog Scale)
Self-reported knee pain intensity using a 100-mm Visual Analog Scale anchored with "0 = no pain" and "100 = worst imaginable pain.
Brief Pain Inventory Scores
Severity and interference of pain over the past 24 hours, measured on a 0-10 scale using the Brief Pain Inventory questionnaire.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Self-administered questionnaire assessing pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores range from 0 (no problems) to 4 (extreme problems) for each domain.
Hospital Anxiety and Depression Scale (HADS) - Total Score
14-item self-report scale assessing anxiety and depression symptoms. Total score range: 0-42; higher scores indicate worse symptoms.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalborg University
Lead sponsor
Lund University
Collaborator
University of Eastern Finland
Collaborator
Aalborg University Hospital
Collaborator