Development of Computational Models to Predict the Short-, Medium- and Long-term Cartilage Degeneration and Pain for Patients With Early-stage Osteoarthritis or Anterior Cruciate Ligament Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging
时间窗: 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.
次要结局
- 40-Meter Fast-Paced Walk Test - Time(Baseline, 1-year, 3-year.)
- Stair Climb Test - Time(Baseline, 1-year, 3-year.)
- Motion capture Surface Electromyography (EMG)(Baseline, 1-year, 3-year.)
- Pressure Pain Tolerance Threshold(Baseline, 1-year, 3-year.)
- Synovial Fluid Protein Biomarker Concentrations - Inflammatory Marker(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Knee Pain Intensity (Visual Analog Scale)(Baseline, 1-year, 3-year, 7-year, 10-year follow-up.)
- Brief Pain Inventory Scores(Baseline, 1-year, 3-year, 7-year, 10-year follow-up.)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 1-year, 3-year, 7-year, 10-year follow-up.)
- Hospital Anxiety and Depression Scale (HADS) - Total Score(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Pittsburgh Sleep Quality Index (PSQI) - Global Score(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Pain Catastrophizing Scale (PCS) - Total Score(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Short Form-12 Health Survey (SF-12) - Physical Component Summary (PCS) Score(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Short Form-12 Health Survey (SF-12) - Mental Component Summary (MCS) Score(Baseline, 1-year, 3-year, 7-year, 10-year.)
- 30-Second Chair Stand Test - Number of Repetitions(Baseline, 1-year, 3-year.)
- Timed Up-and-Go (TUG) Test - Time(Baseline, 1-year, 3-year.)
- 3D Motion Capture - Kinematic Parameters(Baseline, 1-year, 3-year.)
- 3D Motion Capture - Kinetics Parameters(Baseline, 1-year, 3-year.)
- Pressure Pain Detection Threshold(Baseline, 1-year, 3-year.)
- Temporal Summation of Pain(Baseline, 1-year, 3-year.)
- Conditioned Pain Modulation Effect(Baseline, 1-year, 3-year.)
- Plasma Protein Biomarker Concentrations - Inflammatory Markers(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Plasma Protein Biomarker Concentrations - Cartilage Metabolism Markers(Baseline, 1-year, 3-year, 7-year, 10-year.)
- Synovial Fluid Protein Biomarker Concentrations - Cartilage Metabolism Markers(Baseline, 1-year, 3-year, 7-year, 10-year.)
研究者
Morten Bilde Simonsen
Dr.
Aalborg University