Clinical trial NCT06201442: Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Official title: Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2024-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients up until 35 years old with an ACL reconstruction (recruited at the outpatient clinic) Healthy controls (community sample recruited)

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).

Eligibility 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

Primary outcomes:
measure: Knee contact forces (KCF) will be measured using a 3D motion analysis system
timeFrame: 2 years
measure: Knee contact pressures (KCP) will be measured using a 3D motion analysis system
timeFrame: 2 years
measure: The patient-specific cartilage thickness distribution.
timeFrame: 2 years
measure: The patient-specific tibiofemoral cartilage quality.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Faculty of Kinesiology and Rehabilitation Sciences
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Sabine Verschueren, PhD
role: PRINCIPAL_INVESTIGATOR
References: