Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee
Conditions
Keywords
Knee joint, Cartilage degeneration, Biomechanics, Computational modeling, Pain assessment, Musculoskeletal modeling, Finite element analysis, MRI
Brief summary
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.
Interventions
None listed
Sponsors
Lund University
University of Eastern Finland
Aalborg University Hospital
Aalborg University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
.3.1 ACL reconstruction group (n= 25) Inclusion criteria * Adults under 70 years * ACL injury within the last year and planned for ACL reconstruction at inclusion * Informed consent form signed
Exclusion criteria
(at inclusion) * 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). * Unsuitable for MRI (e.g. pacemaker or claustrophobia) * Participants not able to fit the MRI knee coil (Thigh circumference larger than 73.5 cm measured 10 cm above the kneecap and a maximum calf circumferences of 61.5 cm). * Drug addiction defined as the use of cannabis, opioids or other drugs as reported by the participant ACL no reconstruction group (n= 25) Inclusion criteria * Adults under 70 years * ACL injury within the last year and with no plans for ACL reconstruction at inclusion * Informed consent form signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging | Data will be collected at three main time points: baseline, one-year follow-up, and three years follow-up. Additionally, a downscaled protocol will be used to follow the participants at 7- and 10 years follow-ups. | 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Scores | Baseline, 1-year, 3-year, 7-year, 10-year follow-up. | 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) | Baseline, 1-year, 3-year, 7-year, 10-year follow-up. | 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 | Baseline, 1-year, 3-year, 7-year, 10-year. | 14-item self-report scale assessing anxiety and depression symptoms. Total score range: 0-42; higher scores indicate worse symptoms. |
| Pittsburgh Sleep Quality Index (PSQI) - Global Score | Baseline, 1-year, 3-year, 7-year, 10-year. | 19-item questionnaire assessing sleep quality over the past month. Global score range: 0-21; higher scores indicate poorer sleep quality. |
| Pain Catastrophizing Scale (PCS) - Total Score | Baseline, 1-year, 3-year, 7-year, 10-year. | 13-item scale assessing catastrophic thinking related to pain. Total score range: 0-52; higher scores indicate greater pain catastrophizing. |
| Short Form-12 Health Survey (SF-12) - Physical Component Summary (PCS) Score | Baseline, 1-year, 3-year, 7-year, 10-year. | Summary measure of physical health-related quality of life. Score range: 0-100; higher scores indicate better physical health status. |
| Short Form-12 Health Survey (SF-12) - Mental Component Summary (MCS) Score | Baseline, 1-year, 3-year, 7-year, 10-year. | Summary measure of mental health-related quality of life. Score range: 0-100; higher scores indicate better mental health status. |
| 40-Meter Fast-Paced Walk Test - Time | Baseline, 1-year, 3-year. | Time to walk 40 meters at fastest safe pace. Measured in seconds; lower scores indicate better performance. |
| 30-Second Chair Stand Test - Number of Repetitions | Baseline, 1-year, 3-year. | Number of full stands from a seated position completed in 30 seconds. Higher scores indicate better performance. |
| Stair Climb Test - Time | Baseline, 1-year, 3-year. | Time taken to ascend a standard set of stairs. Measured in seconds; lower scores indicate better performance. |
| Timed Up-and-Go (TUG) Test - Time | Baseline, 1-year, 3-year. | Time to rise from a chair, walk 3 meters, turn, return, and sit. Measured in seconds; lower scores indicate better performance. |
| Knee Pain Intensity (Visual Analog Scale) | Baseline, 1-year, 3-year, 7-year, 10-year follow-up. | Self-reported knee pain intensity using a 100-mm Visual Analog Scale anchored with 0 = no pain and 100 = worst imaginable pain. |
| 3D Motion Capture - Kinetics Parameters | Baseline, 1-year, 3-year. | Inverse dynamics calculated from movement patterns and force plates during activities, using 3D motion capture. |
| Motion capture Surface Electromyography (EMG) | Baseline, 1-year, 3-year. | Muscle activation amplitude from selected lower limb muscles, measured in microvolts (µV) and processed per SENIAM guidelines. |
| Pressure Pain Detection Threshold | Baseline, 1-year, 3-year. | Minimum pressure at which a sensation becomes painful, measured in kilopascals (kPa) using a computer-controlled cuff algometer. Higher values indicate reduced sensitivity to pain. |
| Pressure Pain Tolerance Threshold | Baseline, 1-year, 3-year. | Maximum pressure a participant can tolerate, measured in kilopascals (kPa). Higher values indicate greater pain tolerance. |
| Temporal Summation of Pain | Baseline, 1-year, 3-year. | Increase in pain intensity in response to repetitive stimulation, measured as change in pain rating on a 0-10 numeric rating scale. Higher scores indicate greater central sensitization. |
| Conditioned Pain Modulation Effect | Baseline, 1-year, 3-year. | Percentage change in pain rating during a conditioning stimulus, indicating efficiency of endogenous pain inhibition. Higher percentages indicate stronger pain inhibition. |
| Plasma Protein Biomarker Concentrations - Inflammatory Markers | Baseline, 1-year, 3-year, 7-year, 10-year. | Quantitative concentrations of inflammatory biomarkers in plasma using LC-MS/MS and high-multiplex immunoassays (Olink). Higher or lower values indicate changes in inflammatory status. |
| Plasma Protein Biomarker Concentrations - Cartilage Metabolism Markers | Baseline, 1-year, 3-year, 7-year, 10-year. | Quantitative concentrations of cartilage metabolism biomarkers in plasma. Higher or lower values indicate changes in cartilage turnover. |
| Synovial Fluid Protein Biomarker Concentrations - Inflammatory Marker | Baseline, 1-year, 3-year, 7-year, 10-year. | Quantitative concentrations of inflammatory biomarkers in synovial fluid |
| Synovial Fluid Protein Biomarker Concentrations - Cartilage Metabolism Markers | Baseline, 1-year, 3-year, 7-year, 10-year. | Quantitative concentrations of cartilage metabolism biomarkers in synovial fluid |
| 3D Motion Capture - Kinematic Parameters | Baseline, 1-year, 3-year. | Joint angles and Movements patterns during movement, measured in degrees, using 3D motion capture. |
Countries
Denmark
Outcome results
None listed