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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAalborg University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ACL injury within the last year and planned for ACL reconstruction at inclusion

Informed consent form signed

Disqualifiers

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).

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

105 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Knee OA
Group B: ACL reconstruction
Group C: ACL No reconstruction
Group D: Control for Knee OA group
Group E: Control for ACL reconstruction group
Group F: Control for ACL No reconstruction group

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University

Lead sponsor

Lund University

Collaborator

University of Eastern Finland

Collaborator

Aalborg University Hospital

Collaborator