Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
NCT ID: NCT06201442
Last Updated: 2024-01-11
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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UNKNOWN
60 participants
OBSERVATIONAL
2021-11-23
2025-04-30
Brief Summary
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Detailed Description
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The overall goal of this research project is to investigate whether KJPM are related with early cartilage degeneration. This is a first major step towards reducing the risk for post-ACLR onset of Post-Traumatic Knee Osteoarthritis (PTOA).
Two work packages (WP) can be separated, that each have a separate aim:
WP1: The first aim of this WP (WP1.A) is to profile longitudinal changes in knee contact forces (KCFs) and knee contact pressure (KCP) distribution of the articular cartilage in the first 2 years following ACLR. Second, in WP1.B, the investigators will identify multivariate proxies of KCFs (and KCP) to improve clinical translation (for example by facilitating the development of prognostic tools for verifying KJPM in real life).
WP2: the second aim is to establish the relationship between KJPM at different time points following ACLR and (changes in) articular cartilage morphology and quality (WP2.A). Furthermore, the investigators will compare the biomechanical profile of "fast PTOA progressors" with "fast non-traumatic early osteoarthritis progressors" (WP2.B).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR)
4 - 5 visits: Clinical examination, magnetic resonance imaging (MRI), 3D motion analysis, Strength assessment, EOS radiography (full leg X-ray scan), X-ray scan knee, Blood sample, Questionnaires and Activity monitoring.
Imaging - magnetic resonance imaging (MRI)
MRI knee - not standard of care
Blood sampling
blood sample taken and analysis - not standard of care
Assessment of functionality and strength
Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
Activity monitoring
Actigraph measurement- not standard of care
Imaging - x-ray scan (RX)
RX Knee and EOS radiography full leg - not standard of care
Questionnaires
Patient reported outcomes (PROMS)
Healthy controls without previous Anterior Cruciate Ligament (ACL) injury
2 visits: Clinical examination, MRI, 3D motion analysis, Strength assessment, EOS radiography, X-ray scan knee, Blood sample, Questionnaires and Activity monitoring.
Imaging - magnetic resonance imaging (MRI)
MRI knee - not standard of care
Blood sampling
blood sample taken and analysis - not standard of care
Assessment of functionality and strength
Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
Activity monitoring
Actigraph measurement- not standard of care
Imaging - x-ray scan (RX)
RX Knee and EOS radiography full leg - not standard of care
Questionnaires
Patient reported outcomes (PROMS)
Interventions
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Imaging - magnetic resonance imaging (MRI)
MRI knee - not standard of care
Blood sampling
blood sample taken and analysis - not standard of care
Assessment of functionality and strength
Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
Activity monitoring
Actigraph measurement- not standard of care
Imaging - x-ray scan (RX)
RX Knee and EOS radiography full leg - not standard of care
Questionnaires
Patient reported outcomes (PROMS)
Eligibility Criteria
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Inclusion Criteria
* No previous anterior cruciate ligament (ACL) injury
* Body Mass Index (BMI) between 18-30
* Regular physical activity (active during work or practicing sports regularly)
* Signed informed consent to participate
* Age: 18-35 years
* ACL tear which is recently reconstructed or will be reconstructed after enrollment in the current study (the reconstruction will take place within 6 months after injury) with a Hamstring autograft
* BMI between 18-30
* Regular physical activity (active during work or practicing sports regularly)
* Signed informed consent to participate
Exclusion Criteria
* Pre-existing arthritic disease including inflammatory or infectious arthritis
* Major injuries to the lower extremities with absence from sports or daily life activities longer than 2 weeks or that required surgery, less than 6 months before participation
* Pre-existing arthritic disease including inflammatory or infectious arthritis
* Image based confirmation of local cartilage lesion grade 4 or major cartilage damage (Kellgren \& Lawrence \> 2)
* Medial collateral ligament damage (\> grade 2)
* Intra-articular knee fractures
* Menisectomy with \<80% remnant
18 Years
35 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Sabine Verschueren, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Vlaams-Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S65257
Identifier Type: -
Identifier Source: org_study_id
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