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

Aalborg University105 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

105

Conditions

Osteoarthritis, Knee Anterior Cruciate Ligament Injuries

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

.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 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 Early to moderate knee OA stage (n= 25) Inclusion criteria * Adults under 70 years * Diagnosis of knee OA (Kellgren Lawrence (KL) grade 1, 2 and 3 (Kohn et al., 2016). If there is no X-ray that is a maximum of 1 year old, a new one is taken. * Stress-related pain in the knee and knee stiffness * Informed consent form signed Exclusion criteria (at inclusion) * Previous knee surgery * Clinically significant joint disease (inflammatory or degenerative) of other joints than the knee at inclusion. * Severe ischemic or neurological sequelae in the lower extremities. * Clinically significant joint disease (inflammatory or degenerative) to other joints than the knees (according to the clinician). * BMI above 32. * 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 Control groups (3 groups of 10 control participants matched for each of the patient groups, n=30) Inclusion criteria * Adults under 70 years * Informed consent form signed * No radiological changes on a knee x-ray (Arendt-Nielsen et al., 2015). Exclusion criteria (at inclusion) * Previous knee surgery * Self-reported Knee problems (pain, stiffness) * Clinically significant joint disease (inflammatory or degenerative) at inclusion. * Severe ischemic or neurological sequelae in the lower extremities. * BMI above 32. * Unsuitable for MRI (e.g., pacemaker or claustrophobia) * Participants not able to fit the MRI knee coil (Thigh circumference larger than 34.3-73.5 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

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.

Time frame: 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.

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.

Time frame: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.