Clinical trial Recruiting at 2 sites Observational Ages 18 to 70

Predicting knee cartilage wear and pain after early osteoarthritis or a recent ACL injury

Official title: 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

Run by Aalborg University · NCT07134244 · Data updated 2026-11-12

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.

More Osteoarthritis, Knee trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment105 (estimated)
SponsorAalborg University
Academic / other
Locations2 sites (Aalborg, North Denmark and 1 other locations)
StatusRecruiting
StartedSeptember 26, 2024
Main results expectedSeptember 26, 2035
Study endsSeptember 26, 2036
Registry record updatedAugust 21, 2025
Trial IDNCT07134244 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous imaging- and biomechanics-based prediction efforts have shown promise, but integrating longitudinal multimodal data into robust clinical prediction models is still relatively novel.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.