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
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
105 participants
OBSERVATIONAL
2024-09-26
2036-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Knee OA
Participants diagnosed with early-stage knee osteoarthritis. Followed longitudinally to assess cartilage degeneration, pain, and biomarkers.
No interventions assigned to this group
ACL reconstruction
Participants with a history of anterior cruciate ligament injury who have undergone reconstructive surgery. Monitored for cartilage health and OA progression.
No interventions assigned to this group
ACL No reconstruction
Participants with anterior cruciate ligament injury who did not undergo reconstructive surgery. Observed over time for cartilage degeneration and symptoms.
No interventions assigned to this group
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.
No interventions assigned to this group
Control for ACL reconstruction group
Participants with no history of ACL injury or surgery, matched to the ACL reconstruction group. Used as controls.
No interventions assigned to this group
Control for ACL No reconstruction group
Participants without knee injuries, matched to the ACL no reconstruction group. Serve as observational controls.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Lund University
OTHER
University of Eastern Finland
OTHER
Aalborg University Hospital
OTHER
Aalborg University
OTHER
Responsible Party
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Morten Bilde Simonsen
Dr.
Principal Investigators
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Michal Skipper Andersen, Phd
Role: PRINCIPAL_INVESTIGATOR
Department of Materials and Production, Aalborg University, Denmark
Locations
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Aalborg University Hospital
Aalborg, North Denmark, Denmark
Aalborg University
Aalborg, Northen Denmark, Denmark
Countries
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Facility Contacts
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Other Identifiers
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NNF21OC0065373
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
N-20220057
Identifier Type: REGISTRY
Identifier Source: secondary_id
MathKOA_Cohort
Identifier Type: -
Identifier Source: org_study_id
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