NCT06201442

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
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

Conditions

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

Interventions

Type	Name	Description
OTHER	Imaging - magnetic resonance imaging (MRI)	MRI knee - not standard of care
OTHER	Blood sampling	blood sample taken and analysis - not standard of care
OTHER	Assessment of functionality and strength	Movements and posture Analysis Laboratory Leuven measurement (3D motion analysis) and Biodex measurement - not standard of care
OTHER	Activity monitoring	Actigraph measurement- not standard of care
OTHER	Imaging - x-ray scan (RX)	RX Knee and EOS radiography full leg - not standard of care
BEHAVIORAL	Questionnaires	Patient reported outcomes (PROMS)

Timeline

• Start date: 2021-11-23
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-01-11
• Last updated: 2024-01-11

Locations

1 site across 1 country: Belgium