RecruitingNot Applicable

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

Denmark105 participantsStarted 2024-09-26

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

.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 ci…

What they're measuring

Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging

Timeframe: Data will be collected at three main time points: baseline, one-year follow-up, and three years follow-up. Additionally, a downscaled protocol will be used to follow the participants at 7- and 10 years follow-ups.

Trial details

NCT IDNCT07134244

SponsorAalborg University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2035-09-26

View on ClinicalTrials.gov More Osteoarthritis, Knee trials