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

Обзор

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.

Первичные конечные точки

• Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging [Срок оценки: 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.]

Вторичные конечные точки (12)

• Knee Pain Intensity (Visual Analog Scale) [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.]
• Brief Pain Inventory Scores [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.]
• Hospital Anxiety and Depression Scale (HADS) - Total Score [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year.]
• Pittsburgh Sleep Quality Index (PSQI) - Global Score [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year.]
• Pain Catastrophizing Scale (PCS) - Total Score [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year.]
• Short Form-12 Health Survey (SF-12) - Physical Component Summary (PCS) Score [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year.]
• Short Form-12 Health Survey (SF-12) - Mental Component Summary (MCS) Score [Срок оценки: Baseline, 1-year, 3-year, 7-year, 10-year.]
• 40-Meter Fast-Paced Walk Test - Time [Срок оценки: Baseline, 1-year, 3-year.]
• 30-Second Chair Stand Test - Number of Repetitions [Срок оценки: Baseline, 1-year, 3-year.]
• Stair Climb Test - Time [Срок оценки: Baseline, 1-year, 3-year.]
• Timed Up-and-Go (TUG) Test - Time [Срок оценки: Baseline, 1-year, 3-year.]

Критерии участия

.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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 2 центра

• Aalborg University Hospital — Aalborg
• Aalborg University — Aalborg

Идентификаторы

NCT: NCT07134244 · MathKOA_Cohort · NNF21OC0065373 · N-20220057

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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