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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
This research project is a longitudinal prospective study. The investigators aim to define the KJPM longitudinally in the first 2 years following ACLR. The investigators relate these KJPM, combined with the cumulative mechanical exposure, to changes in articular cartilage/joint surface morphology and quality. To investigate the loading pattern on the knee joint, daily activities like walking, running and climbing stairs will be performed by the participants.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging - magnetic resonance imaging (MRI) | Other | MRI knee - not standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria (healthy volunteers):
Exclusion Criteria (healthy volunteers):
Inclusion Criteria (ACL patients):
Exclusion Criteria (ACL patients):
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Adult patients up until 35 years old with an ACL reconstruction (recruited at the outpatient clinic) Healthy controls (community sample recruited)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Verschueren, PhD | Contact | 0032 16 32 90 70 | sabine.verschueren@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Verschueren, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Kinesiology and Rehabilitation Sciences | Recruiting | Leuven | Vlaams-Brabant | 3001 | Belgium |
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.
Upon publication of the research results and for an undetermined period of time.
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.
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Blood samples
| Blood sampling | Other | blood sample taken and analysis - not standard of care |
|
| Assessment of functionality and strength | Other | Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care |
|
| Activity monitoring | Other | Actigraph measurement- not standard of care |
|
| Imaging - x-ray scan (RX) | Other | RX Knee and EOS radiography full leg - not standard of care |
|
| Questionnaires | Behavioral | Patient reported outcomes (PROMS) |
|
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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