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 (MathKOA)

Aalborg University

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee

Study type: Observational

Funder types: Other

Identifiers

NCT07134244

N-20220057 (Registry Identifier)

NNF21OC0065373 (Other Grant/Funding Number)

MathKOA_Cohort

Details and patient eligibility

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

105 participants in 6 patient groups

Knee OA

Description:

Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers.

ACL reconstruction

Description:

Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression.

ACL No reconstruction

Description:

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

Description:

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

Description:

Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls.

Control for ACL No reconstruction group

Description:

Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls.