Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201442
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-01-26
Brief Title:
Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cartilagejoint 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 WP1A 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 WP1B 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 WP2A Furthermore the investigators will compare the biomechanical profile of fast PTOA progressors with fast non-traumatic early osteoarthritis progressors WP2B
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 WP1A 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 WP1B 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 WP2A Furthermore the investigators will compare the biomechanical profile of fast PTOA progressors with fast non-traumatic early osteoarthritis progressors WP2B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None