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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06201442
Enrollment
60
Registered
2024-01-11
Start date
2021-11-23
Completion date
2025-04-30
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries, Post-Traumatic Osteoarthritis of Knee

Keywords

ACLR, Anterior cruciate ligament injury, PTOA, post-traumatic knee osteoarthritis, KJPM, knee joint pathomechanics

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.

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).

Interventions

OTHERImaging - magnetic resonance imaging (MRI)

MRI knee - not standard of care

OTHERBlood sampling

blood sample taken and analysis - not standard of care

OTHERAssessment of functionality and strength

Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care

Actigraph measurement- not standard of care

OTHERImaging - x-ray scan (RX)

RX Knee and EOS radiography full leg - not standard of care

BEHAVIORALQuestionnaires

Patient reported outcomes (PROMS)

Sponsors

KU Leuven
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

(healthy volunteers): * 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

Exclusion criteria

(healthy volunteers): * 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 Inclusion Criteria (ACL patients): * 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

Design outcomes

Primary

MeasureTime frameDescription
Knee contact forces (KCF) will be measured using a 3D motion analysis system2 yearsThe 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 system2 yearsUsing 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.2 yearsThe 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.2 yearsThe cartilage quality will be examined using compositional measures such as T1rho, T1p and T2 relaxation time.

Countries

Belgium

Contacts

Primary ContactSabine Verschueren, PhD
sabine.verschueren@kuleuven.be0032 16 32 90 70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026