Investigating knee joint mechanics after ACL reconstruction
Profiling of Abnormal Knee Joint Loading to Reduce Risk of Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Universitaire Ziekenhuizen KU Leuven · NCT06201442
This study is trying to see how the mechanics of the knee change after ACL surgery and how those changes might affect cartilage health in people over the first two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06201442 on ClinicalTrials.gov |
What this trial studies
This observational study aims to define knee joint pathomechanics (KJPM) in the first two years following anterior cruciate ligament reconstruction (ACLR) and relate these mechanics to changes in articular cartilage morphology and quality. Participants will engage in daily activities such as walking, running, and climbing stairs, while their knee contact forces and pressures will be monitored. The study seeks to establish a connection between KJPM and early cartilage degeneration, potentially leading to better prognostic tools for post-traumatic knee osteoarthritis (PTOA).
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 18-35 with no previous ACL injuries and active lifestyles, as well as ACL patients who are undergoing reconstruction.
Not a fit: Patients with major lower extremity injuries or pre-existing arthritic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention strategies for post-traumatic knee osteoarthritis in patients who have undergone ACL reconstruction.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding knee mechanics and their relationship to osteoarthritis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams-Brabant
- Faculty of Kinesiology and Rehabilitation Sciences — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
Study contacts
- Principal investigator: Sabine Verschueren, PhD — KU Leuven
- Study coordinator: Sabine Verschueren, PhD
- Email: sabine.verschueren@kuleuven.be
- Phone: 0032 16 32 90 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Cruciate Ligament Injuries, Post-Traumatic Osteoarthritis of Knee, ACLR, Anterior cruciate ligament injury, PTOA, post-traumatic knee osteoarthritis, KJPM, knee joint pathomechanics