Osteoarthritis, KneeMathKOANCT07134244
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
An observational study of Osteoarthritis, Knee and Anterior Cruciate Ligament Injuries, run by Aalborg University at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Anterior Cruciate Ligament Injuries
- How many people
- 105 participants
- Where
- 2 sitesDenmark
- Study dates
- 26 Sep 2024to 26 Sep 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Knee OA Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers. ACL Reconstruction Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression. ACL No Reconstruction 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 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 Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls. Control for ACL No Reconstruction Group Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls.
.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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, North Denmark, 9000
Carsten Møller Poulsen Mølgaard, Dr., 97662533 ext. +45, cmm@rn.dk
- Recruiting
Aalborg University
Aalborg, Northen Denmark, 9220
Morten Bilde Simonsen, 51344176 ext. +45, mbsi@mp.aau.dk
Michael Skipper Andersen, PhD
About this study
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.
- Keywords
- Knee joint, Cartilage degeneration, Biomechanics, Computational modeling, Pain assessment, Musculoskeletal modeling, Finite element analysis, MRI
- Medical subject headings
- Osteoarthritis, Knee, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee OA | Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers. | |
| ACL reconstruction | Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression. | |
| ACL No reconstruction | 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 | 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 | Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls. | |
| Control for ACL No reconstruction group | Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging
Person-specific 3T MRI scans will be used to measure changes in knee cartilage, including T1ρ and T2 relaxation times and 3D geometry, as indicators of cartilage biochemical composition and structural integrity. Analyses will be used for predictive computational modeling of cartilage degeneration.
Measured: 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.
Secondary outcomes (23)
Knee Pain Intensity (Visual Analog Scale)
Self-reported knee pain intensity using a 100-mm Visual Analog Scale anchored with "0 = no pain" and "100 = worst imaginable pain.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.
Brief Pain Inventory Scores
Severity and interference of pain over the past 24 hours, measured on a 0-10 scale using the Brief Pain Inventory questionnaire.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Self-administered questionnaire assessing pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores range from 0 (no problems) to 4 (extreme problems) for each domain.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.
Hospital Anxiety and Depression Scale (HADS) - Total Score
14-item self-report scale assessing anxiety and depression symptoms. Total score range: 0-42; higher scores indicate worse symptoms.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Pittsburgh Sleep Quality Index (PSQI) - Global Score
19-item questionnaire assessing sleep quality over the past month. Global score range: 0-21; higher scores indicate poorer sleep quality.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Pain Catastrophizing Scale (PCS) - Total Score
13-item scale assessing catastrophic thinking related to pain. Total score range: 0-52; higher scores indicate greater pain catastrophizing.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Short Form-12 Health Survey (SF-12) - Physical Component Summary (PCS) Score
Summary measure of physical health-related quality of life. Score range: 0-100; higher scores indicate better physical health status.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Short Form-12 Health Survey (SF-12) - Mental Component Summary (MCS) Score
Summary measure of mental health-related quality of life. Score range: 0-100; higher scores indicate better mental health status.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
40-Meter Fast-Paced Walk Test - Time
Time to walk 40 meters at fastest safe pace. Measured in seconds; lower scores indicate better performance.
Measured: Baseline, 1-year, 3-year.
30-Second Chair Stand Test - Number of Repetitions
Number of full stands from a seated position completed in 30 seconds. Higher scores indicate better performance.
Measured: Baseline, 1-year, 3-year.
Stair Climb Test - Time
Time taken to ascend a standard set of stairs. Measured in seconds; lower scores indicate better performance.
Measured: Baseline, 1-year, 3-year.
Timed Up-and-Go (TUG) Test - Time
Time to rise from a chair, walk 3 meters, turn, return, and sit. Measured in seconds; lower scores indicate better performance.
Measured: Baseline, 1-year, 3-year.
3D Motion Capture - Kinematic Parameters
Joint angles and Movements patterns during movement, measured in degrees, using 3D motion capture.
Measured: Baseline, 1-year, 3-year.
3D Motion Capture - Kinetics Parameters
Inverse dynamics calculated from movement patterns and force plates during activities, using 3D motion capture.
Measured: Baseline, 1-year, 3-year.
Motion capture Surface Electromyography (EMG)
Muscle activation amplitude from selected lower limb muscles, measured in microvolts (µV) and processed per SENIAM guidelines.
Measured: Baseline, 1-year, 3-year.
Pressure Pain Detection Threshold
Minimum pressure at which a sensation becomes painful, measured in kilopascals (kPa) using a computer-controlled cuff algometer. Higher values indicate reduced sensitivity to pain.
Measured: Baseline, 1-year, 3-year.
Pressure Pain Tolerance Threshold
Maximum pressure a participant can tolerate, measured in kilopascals (kPa). Higher values indicate greater pain tolerance.
Measured: Baseline, 1-year, 3-year.
Temporal Summation of Pain
Increase in pain intensity in response to repetitive stimulation, measured as change in pain rating on a 0-10 numeric rating scale. Higher scores indicate greater central sensitization.
Measured: Baseline, 1-year, 3-year.
Conditioned Pain Modulation Effect
Percentage change in pain rating during a conditioning stimulus, indicating efficiency of endogenous pain inhibition. Higher percentages indicate stronger pain inhibition.
Measured: Baseline, 1-year, 3-year.
Plasma Protein Biomarker Concentrations - Inflammatory Markers
Quantitative concentrations of inflammatory biomarkers in plasma using LC-MS/MS and high-multiplex immunoassays (Olink). Higher or lower values indicate changes in inflammatory status.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Plasma Protein Biomarker Concentrations - Cartilage Metabolism Markers
Quantitative concentrations of cartilage metabolism biomarkers in plasma. Higher or lower values indicate changes in cartilage turnover.
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Synovial Fluid Protein Biomarker Concentrations - Inflammatory Marker
Quantitative concentrations of inflammatory biomarkers in synovial fluid
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Synovial Fluid Protein Biomarker Concentrations - Cartilage Metabolism Markers
Quantitative concentrations of cartilage metabolism biomarkers in synovial fluid
Measured: Baseline, 1-year, 3-year, 7-year, 10-year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start26 Sep 2024
- Primary completion26 Sep 2035 (estimated)
- Study completion26 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, University of Eastern Finland, Aalborg University Hospital
- Responsible party
- Principal investigator, Morten Bilde Simonsen, Aalborg University
- Investigators
- Michal Skipper Andersen, Phd, Principal investigator, Department of Materials and Production, Aalborg University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134244
- Sponsor's protocol ID
- MathKOA_Cohort
- Other IDs
- NNF21OC0065373, N-20220057
- Acronym
- MathKOA
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07134244
- Acronym / sponsor ID
- MathKOA / MathKOA_Cohort
- Keywords
- Knee joint, Cartilage degeneration, Biomechanics, Computational modeling, Pain assessment, Musculoskeletal modeling, Finite element analysis, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Lund University, University of Eastern Finland, Aalborg University Hospital
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 26 Sep 2035 (estimated)
- Study completion
- 26 Sep 2036 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Knee OA | – | –Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers. |
| ACL reconstruction | – | –Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression. |
| ACL No reconstruction | – | –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 | – | –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 | – | –Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls. |
| Control for ACL No reconstruction group | – | –Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Knee OA Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers. ACL Reconstruction Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression. ACL No Reconstruction 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 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 Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls. Control for ACL No Reconstruction Group Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging
Time frame: 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.
Person-specific 3T MRI scans will be used to measure changes in knee cartilage, including T1ρ and T2 relaxation times and 3D geometry, as indicators of cartilage biochemical composition and structural integrity. Analyses will be used for predictive computational modeling of cartilage degeneration.
23 secondary outcomes
Knee Pain Intensity (Visual Analog Scale)
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.
Brief Pain Inventory Scores
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year follow-up.
Hospital Anxiety and Depression Scale (HADS) - Total Score
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Pittsburgh Sleep Quality Index (PSQI) - Global Score
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Pain Catastrophizing Scale (PCS) - Total Score
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Short Form-12 Health Survey (SF-12) - Physical Component Summary (PCS) Score
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Short Form-12 Health Survey (SF-12) - Mental Component Summary (MCS) Score
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
40-Meter Fast-Paced Walk Test - Time
Time frame: Baseline, 1-year, 3-year.
30-Second Chair Stand Test - Number of Repetitions
Time frame: Baseline, 1-year, 3-year.
Stair Climb Test - Time
Time frame: Baseline, 1-year, 3-year.
Timed Up-and-Go (TUG) Test - Time
Time frame: Baseline, 1-year, 3-year.
3D Motion Capture - Kinematic Parameters
Time frame: Baseline, 1-year, 3-year.
3D Motion Capture - Kinetics Parameters
Time frame: Baseline, 1-year, 3-year.
Motion capture Surface Electromyography (EMG)
Time frame: Baseline, 1-year, 3-year.
Pressure Pain Detection Threshold
Time frame: Baseline, 1-year, 3-year.
Pressure Pain Tolerance Threshold
Time frame: Baseline, 1-year, 3-year.
Temporal Summation of Pain
Time frame: Baseline, 1-year, 3-year.
Conditioned Pain Modulation Effect
Time frame: Baseline, 1-year, 3-year.
Plasma Protein Biomarker Concentrations - Inflammatory Markers
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Plasma Protein Biomarker Concentrations - Cartilage Metabolism Markers
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Synovial Fluid Protein Biomarker Concentrations - Inflammatory Marker
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Synovial Fluid Protein Biomarker Concentrations - Cartilage Metabolism Markers
Time frame: Baseline, 1-year, 3-year, 7-year, 10-year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Skipper Andersen, Phd principal investigator
Department of Materials and Production, Aalborg University, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Anterior Cruciate Ligament Injuries, run by Aalborg University at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Cartilage Composition and Structure Assessed by Quantitative Magnetic Resonance Imaging (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.