NCT07134244 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
| NCT ID | NCT07134244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University |
| Condition | Osteoarthritis, Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2035-09-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2024-09-26 with a primary completion date of 2035-09-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Michal Skipper Andersen, Phd
PRINCIPAL INVESTIGATOR
Department of Materials and Production, Aalborg University, Denmark
Frequently Asked Questions
Who can join the NCT07134244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07134244 currently recruiting?
Yes, NCT07134244 is actively recruiting participants. Visit ClinicalTrials.gov or contact Aalborg University to inquire about joining.
Where is the NCT07134244 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aalborg, Denmark.
Who is sponsoring the NCT07134244 clinical trial?
NCT07134244 is sponsored by Aalborg University. The principal investigator is Michal Skipper Andersen, Phd at Department of Materials and Production, Aalborg University, Denmark. The trial plans to enroll 105 participants.