Development of Computational Models to Predict the Short-, Medium- and Long-term Cartilage Degene… (NCT07134244) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.