Anterior Cruciate Ligament InjuriesNCT06201442
Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Injuries and Post-Traumatic Osteoarthritis of Knee, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Post-Traumatic Osteoarthritis of Knee
- What is being tested?
- Imaging - magnetic resonance imaging (MRI), Blood sampling and Assessment of functionality and strength
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Nov 2021to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult patients up until 35 years old with an ACL reconstruction (recruited at the outpatient clinic) Healthy controls (community sample recruited)
Who may be able to join
- 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
- Age: 18-35 years
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- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Vlaams-Brabant, 3001
Sabine Verschueren, Prof., 16 32 90 70 ext. +32, sabine.verschueren@kuleuven.be
About this study
Official title: Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
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.
Read the detailed description
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).
- Being tested
- Imaging - magnetic resonance imaging (MRI), Blood sampling, Assessment of functionality and strength, Activity monitoring, Imaging - x-ray scan (RX)
- Keywords
- ACLR, Anterior cruciate ligament injury, PTOA, post-traumatic knee osteoarthritis, KJPM, knee joint pathomechanics
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging - magnetic resonance imaging (MRI)Other
MRI knee - not standard of care
Blood samplingOther
blood sample taken and analysis - not standard of care
Assessment of functionality and strengthOther
Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
Activity monitoringOther
Actigraph measurement- not standard of care
Imaging - x-ray scan (RX)Other
RX Knee and EOS radiography full leg - not standard of care
QuestionnairesBehavioural
Patient reported outcomes (PROMS)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Imaging - magnetic resonance imaging (MRI); Other: Blood sampling; Other: Assessment of functionality and strength; Other: Activity monitoring; Other: Imaging - x-ray scan (RX); Behavioral: Questionnaires | |
| 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. Receives: Other: Imaging - magnetic resonance imaging (MRI); Other: Blood sampling; Other: Assessment of functionality and strength; Other: Activity monitoring; Other: Imaging - x-ray scan (RX); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start23 Nov 2021
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Sabine Verschueren, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201442
- Sponsor's protocol ID
- S65257
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06201442
- Acronym / sponsor ID
- S65257
- Keywords
- ACLR, Anterior cruciate ligament injury, PTOA, post-traumatic knee osteoarthritis, KJPM, knee joint pathomechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 11 Jan 2024 (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.
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.
Detailed description
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) | – | Other: Imaging - magnetic resonance imaging (MRI), Other: Blood sampling, Other: Assessment of functionality and strength, Other: Activity monitoring, Other: Imaging - x-ray scan (RX), Behavioral: Questionnaires4 - 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 | – | Other: Imaging - magnetic resonance imaging (MRI), Other: Blood sampling, Other: Assessment of functionality and strength, Other: Activity monitoring, Other: Imaging - x-ray scan (RX), Behavioral: Questionnaires2 visits: Clinical examination, MRI, 3D motion analysis, Strength assessment, EOS radiography, X-ray scan knee, Blood sample, Questionnaires and Activity monitoring. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult patients up until 35 years old with an ACL reconstruction (recruited at the outpatient clinic) Healthy controls (community sample recruited)
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging - magnetic resonance imaging (MRI)MRI knee - not standard of care | Other | Healthy controls without previous Anterior Cruciate Ligament (ACL) injury, Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) |
| Blood samplingblood sample taken and analysis - not standard of care | Other | Healthy controls without previous Anterior Cruciate Ligament (ACL) injury, Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) |
| Assessment of functionality and strengthMovements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care | Other | Healthy controls without previous Anterior Cruciate Ligament (ACL) injury, Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) |
| Activity monitoringActigraph measurement- not standard of care | Other | Healthy controls without previous Anterior Cruciate Ligament (ACL) injury, Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) |
| Imaging - x-ray scan (RX)RX Knee and EOS radiography full leg - not standard of care | Other | Healthy controls without previous Anterior Cruciate Ligament (ACL) injury, Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) |
| QuestionnairesPatient reported outcomes (PROMS) | Behavioural | Healthy controls without previous Anterior Cruciate Ligament (ACL) injury, Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR) |
Primary outcome
Knee contact forces (KCF) will be measured using a 3D motion analysis system
Time frame: 2 years
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.
Knee contact pressures (KCP) will be measured using a 3D motion analysis system
Time frame: 2 years
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.
The patient-specific cartilage thickness distribution.
Time frame: 2 years
The cartilage thickness will be measured using the semi-automatic segmentation from the high-resolution images (3D-FSE) of the tibiofemoral cartilage.
The patient-specific tibiofemoral cartilage quality.
Time frame: 2 years
The cartilage quality will be examined using compositional measures such as T1rho, T1p and T2 relaxation time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Sabine Verschueren, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Post-Traumatic Osteoarthritis of Knee, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Verschueren, PhD (0032 16 32 90 70, sabine.verschueren@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee contact forces (KCF) will be measured using a 3D motion analysis system (time frame: 2 years). The study lists 4 primary outcomes in all. 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 11 Jan 2024.