Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
1 other identifier
observational
60
1 country
1
Brief Summary
The purpose of this trial is to define knee joint pathomechanics (KJPM) in the first 2 years after ACL reconstruction (ACLR) and relate these KJPM with changes in articular cartilage morphology and quality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2021
CompletedFirst Submitted
Initial submission to the registry
January 26, 2023
CompletedFirst Posted
Study publicly available on registry
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJanuary 11, 2024
August 1, 2023
3.4 years
January 26, 2023
December 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Knee contact forces (KCF) will be measured using a 3D motion analysis system
The goal is to profile longitudinal changes in KCFs of the articular cartilage. Using a 3D motion analysis system (Vicon, Oxford Metrics, UK), marker trajectories, ground reaction forces (AMTI, MA, USA) and muscle activations (Wireless EMG Cometa, Italy) will be measured. Subsequently a musculoskeletal modelling workflow in OpenSim will be used to calculate Knee contact forces (KCF) of the articular cartilage.
2 years
Knee contact pressures (KCP) will be measured using a 3D motion analysis system
Using a 3D motion analysis system (Vicon, Oxford Metrics, UK), marker trajectories, ground reaction forces (AMTI, MA, USA) and muscle activations (Wireless EMG Cometa, Italy) will be measured. Subsequently a musculoskeletal modelling workflow in OpenSim will be used to calculate Knee contact pressures (KCP) of the articular cartilage.
2 years
The patient-specific cartilage thickness distribution.
The cartilage thickness will be measured using the semi-automatic segmentation from the high-resolution images (3D-FSE) of the tibiofemoral cartilage.
2 years
The patient-specific tibiofemoral cartilage quality.
The cartilage quality will be examined using compositional measures such as T1rho, T1p and T2 relaxation time.
2 years
Study Arms (2)
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.
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.
Interventions
MRI knee - not standard of care
blood sample taken and analysis - not standard of care
Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
Actigraph measurement- not standard of care
RX Knee and EOS radiography full leg - not standard of care
Patient reported outcomes (PROMS)
Eligibility Criteria
Adult patients up until 35 years old with an ACL reconstruction (recruited at the outpatient clinic) Healthy controls (community sample recruited)
You may qualify if:
- Age: 18-35 years
- 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
You may not qualify if:
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- KU Leuvencollaborator
Study Sites (1)
Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Vlaams-Brabant, 3001, Belgium
Biospecimen
Blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Verschueren, PhD
KU Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2023
First Posted
January 11, 2024
Study Start
November 23, 2021
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
January 11, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Upon publication of the research results and for an undetermined period of time.
- Access Criteria
- Data sharing can only happen when it is not for commercial use or it doesn't reveal the identity of the participants. Data will always be pseudonimized. A written request has to be submitted to the PI.
The full pseudonymized dataset will be made available in RDR (KU Leuven tool) and will be shared upon written request after approval of the PI, for clearly defined research purposes. Pseudonymized data and documentation will be available on request in RDR. Data sharing can only happen when it is not for commercial use or it doesn't reveal the identity of the participants. Data will always be pseudonimized.