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
Recruiting · NCT07134244 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aalborg University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed.
- Aalborg University Hospital - Aalborg, North Denmark, Denmark
- Aalborg University - Aalborg, Northen Denmark, Denmark