Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Post-Traumatic Osteoarthritis of Knee
• Interventions: 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

• Registration Number: NCT06201442
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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).

Study Timeline

• Study Start: 2021-11-23
• Study First Submitted: 2023-01-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Knee contact forces (KCF) will be measured using a 3D motion analysis system	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	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.	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.	2 years	The cartilage quality will be examined using compositional measures such as T1rho, T1p and T2 relaxation time.

Trial Locations

Locations (1)

Faculty of Kinesiology and Rehabilitation Sciences; 🇧🇪 Leuven, Vlaams-Brabant, Belgium