Predicting knee cartilage wear and pain after early osteoarthritis or a recent ACL injury
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
This project will try to create computer models that predict cartilage damage and pain over time for people with early knee osteoarthritis or an ACL injury within the past year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Aalborg University Academic / other |
| Locations | 2 sites (Aalborg, North Denmark and 1 other locations) |
| Trial ID | NCT07134244 on ClinicalTrials.gov |
What this trial studies
This observational project will follow adults with early-stage knee osteoarthritis or a recent ACL injury and collect medical imaging, movement analysis, muscle strength testing, pain scores, questionnaires, and biomarkers over time. Researchers will combine these multimodal data to build computational biomechanics and statistical models that forecast short-, medium- and long-term cartilage degeneration and pain. The protocol includes separate cohorts for patients planning ACL reconstruction and those not having reconstruction to capture different recovery pathways. The aim is to provide individualized risk and outcome predictions that can inform choices about non-drug treatments such as braces or exercise programs.
Who should consider this trial
Good fit: Adults under 70 with early knee osteoarthritis or an ACL injury within the last year who can undergo MRI, complete movement testing, and provide informed consent are ideal candidates.
Not a fit: People with advanced or inflammatory joint disease in other joints, BMI over 32, prior knee surgery before the current trauma, inability to have MRI, or active substance use are unlikely to benefit from the study's predictions.
Why it matters
Potential benefit: If successful, the models could help clinicians pick more personalized non-drug treatments to slow cartilage loss and reduce knee pain.
How similar studies have performed: Previous imaging- and biomechanics-based prediction efforts have shown promise, but integrating longitudinal multimodal data into robust clinical prediction models is still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
.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
Where this trial is running
Aalborg, North Denmark and 1 other locations
- Aalborg University Hospital — Aalborg, North Denmark, Denmark (Recruiting)
- Aalborg University — Aalborg, Northen Denmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Michal Skipper Andersen, Phd — Department of Materials and Production, Aalborg University, Denmark
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.