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| ID | Type | Description | Link |
|---|---|---|---|
| NNF21OC0065373 | Other Grant/Funding Number | Novo Nordisk Fonden | |
| N-20220057 | Registry Identifier | The North Denmark Region Committee on Health Research Ethics |
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| Name | Class |
|---|---|
| Lund University | OTHER |
| University of Eastern Finland | OTHER |
| Aalborg University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1-year, 3-year, 7-year, 10-year follow-up. |
| Brief Pain Inventory Scores |
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.3.1 ACL reconstruction group (n= 25) Inclusion criteria
ACL no reconstruction group (n= 25) Inclusion criteria
Early to moderate knee OA stage (n= 25) Inclusion criteria
Control groups (3 groups of 10 control participants matched for each of the patient groups, n=30) Inclusion criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michal Skipper Andersen, Phd | Department of Materials and Production, Aalborg University, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | North Denmark | 9000 | Denmark |
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Synovial fluid and blood samples will be collected from participants at designated study visits. These samples will be used for protein and biomarker analysis related to inflammation, cartilage metabolism, and disease progression. No DNA will be extracted or analyzed from any biospecimens. Samples will be stored under appropriate conditions until analysis is completed.
Severity and interference of pain over the past 24 hours, measured on a 0-10 scale using the Brief Pain Inventory questionnaire. |
| Baseline, 1-year, 3-year, 7-year, 10-year follow-up. |
| 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. | Baseline, 1-year, 3-year, 7-year, 10-year follow-up. |
| 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. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Pittsburgh Sleep Quality Index (PSQI) - Global Score | 19-item questionnaire assessing sleep quality over the past month. Global score range: 0-21; higher scores indicate poorer sleep quality. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Pain Catastrophizing Scale (PCS) - Total Score | 13-item scale assessing catastrophic thinking related to pain. Total score range: 0-52; higher scores indicate greater pain catastrophizing. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Short Form-12 Health Survey (SF-12) - Physical Component Summary (PCS) Score | Summary measure of physical health-related quality of life. Score range: 0-100; higher scores indicate better physical health status. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Short Form-12 Health Survey (SF-12) - Mental Component Summary (MCS) Score | Summary measure of mental health-related quality of life. Score range: 0-100; higher scores indicate better mental health status. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| 40-Meter Fast-Paced Walk Test - Time | Time to walk 40 meters at fastest safe pace. Measured in seconds; lower scores indicate better performance. | Baseline, 1-year, 3-year. |
| 30-Second Chair Stand Test - Number of Repetitions | Number of full stands from a seated position completed in 30 seconds. Higher scores indicate better performance. | Baseline, 1-year, 3-year. |
| Stair Climb Test - Time | Time taken to ascend a standard set of stairs. Measured in seconds; lower scores indicate better performance. | Baseline, 1-year, 3-year. |
| Timed Up-and-Go (TUG) Test - Time | Time to rise from a chair, walk 3 meters, turn, return, and sit. Measured in seconds; lower scores indicate better performance. | Baseline, 1-year, 3-year. |
| 3D Motion Capture - Kinematic Parameters | Joint angles and Movements patterns during movement, measured in degrees, using 3D motion capture. | Baseline, 1-year, 3-year. |
| 3D Motion Capture - Kinetics Parameters | Inverse dynamics calculated from movement patterns and force plates during activities, using 3D motion capture. | Baseline, 1-year, 3-year. |
| Motion capture Surface Electromyography (EMG) | Muscle activation amplitude from selected lower limb muscles, measured in microvolts (µV) and processed per SENIAM guidelines. | Baseline, 1-year, 3-year. |
| Pressure Pain Detection Threshold | 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. | Baseline, 1-year, 3-year. |
| Pressure Pain Tolerance Threshold | Maximum pressure a participant can tolerate, measured in kilopascals (kPa). Higher values indicate greater pain tolerance. | Baseline, 1-year, 3-year. |
| Temporal Summation of Pain | 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. | Baseline, 1-year, 3-year. |
| Conditioned Pain Modulation Effect | Percentage change in pain rating during a conditioning stimulus, indicating efficiency of endogenous pain inhibition. Higher percentages indicate stronger pain inhibition. | Baseline, 1-year, 3-year. |
| Plasma Protein Biomarker Concentrations - Inflammatory Markers | 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. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Plasma Protein Biomarker Concentrations - Cartilage Metabolism Markers | Quantitative concentrations of cartilage metabolism biomarkers in plasma. Higher or lower values indicate changes in cartilage turnover. | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Synovial Fluid Protein Biomarker Concentrations - Inflammatory Marker | Quantitative concentrations of inflammatory biomarkers in synovial fluid | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Synovial Fluid Protein Biomarker Concentrations - Cartilage Metabolism Markers | Quantitative concentrations of cartilage metabolism biomarkers in synovial fluid | Baseline, 1-year, 3-year, 7-year, 10-year. |
| Aalborg University | Recruiting | Aalborg | Northen Denmark | 9220 | Denmark |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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