RecruitingNCT07134244

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

Sponsor

Aalborg University

Enrollment

105 participants

Start Date

Sep 26, 2024

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis, Knee Anterior Cruciate Ligament Injuries

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 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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

Adults under 70 years
ACL injury within the last year and planned for ACL reconstruction at inclusion
Adults under 70 years
ACL injury within the last year and with no plans for ACL reconstruction at inclusion
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
Adults under 70 years
Informed consent form signed

Exclusion Criteria30

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
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
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
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