Status:
RECRUITING
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
Lead Sponsor:
Aalborg University
Collaborating Sponsors:
Lund University
University of Eastern Finland
Conditions:
Osteoarthritis, Knee
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
18-70 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- .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
Exclusion
Key Trial Info
Start Date :
September 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 26 2036
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT07134244
Start Date
September 26 2024
End Date
September 26 2036
Last Update
August 21 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Aalborg University Hospital
Aalborg, North Denmark, Denmark, 9000
2
Aalborg University
Aalborg, Northen Denmark, Denmark, 9220