ClinicalTrials.Veeva

Menu

Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction

U

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Post-Traumatic Osteoarthritis of Knee
Anterior Cruciate Ligament Injuries

Treatments

Other: Activity monitoring
Other: Imaging - x-ray scan (RX)
Other: Imaging - magnetic resonance imaging (MRI)
Behavioral: Questionnaires
Other: Assessment of functionality and strength
Other: Blood sampling

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria (ACL patients):

  • 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 design

60 participants in 2 patient groups

Patients undergoing unilateral Anterior Cruciate Ligament Reconstruction (ACLR)
Description:
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.
Treatment:
Other: Activity monitoring
Other: Assessment of functionality and strength
Other: Blood sampling
Other: Imaging - magnetic resonance imaging (MRI)
Behavioral: Questionnaires
Other: Imaging - x-ray scan (RX)
Healthy controls without previous Anterior Cruciate Ligament (ACL) injury
Description:
2 visits: Clinical examination, MRI, 3D motion analysis, Strength assessment, EOS radiography, X-ray scan knee, Blood sample, Questionnaires and Activity monitoring.
Treatment:
Other: Activity monitoring
Other: Assessment of functionality and strength
Other: Blood sampling
Other: Imaging - magnetic resonance imaging (MRI)
Behavioral: Questionnaires
Other: Imaging - x-ray scan (RX)

Trial contacts and locations

1

Loading...

Central trial contact

Sabine Verschueren, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems