Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201442
• Other study ID #: S65257
• Status: Recruiting
• Start date: November 23, 2021
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Sabine Verschueren, PhD
• Phone: 0032 16 32 90 70
• Email: sabine.verschueren[@]kuleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Osteoarthritis
• Osteoarthritis, Knee
• Post-Traumatic Osteoarthritis of Knee

Intervention

Other:
• Imaging - magnetic resonance imaging (MRI)
MRI knee - not standard of care
• Blood sampling
blood sample taken and analysis - not standard of care
• Assessment of functionality and strength
Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
• Activity monitoring
Actigraph measurement- not standard of care
• Imaging - x-ray scan (RX)
RX Knee and EOS radiography full leg - not standard of care

Behavioral:
• Questionnaires
Patient reported outcomes (PROMS)

Locations

Country	Name	City	State
Belgium	Faculty of Kinesiology and Rehabilitation Sciences	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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