Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Nov 26, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Episealer® device, which is designed to help patients with specific cartilage damage in their knees. The goal is to see how well this device works, how safe it is, and how it performs over a long period of time—up to 10 years. The trial is currently looking for 30 participants aged 18 years and older, particularly those over 40, who have had unsuccessful previous treatments for their knee cartilage issues.

To be eligible for the trial, participants should have a specific type of cartilage injury in their knee that makes them suitable for this particular implant, as determined by MRI scans. Participants will need to provide informed consent, meaning they understand what the study involves. However, individuals with certain knee problems, severe arthritis, or those who can't undergo an MRI will not be able to participate. Those who join the study can expect regular follow-ups over the years to monitor their progress and the device's performance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
• • Minimal age 18 years (Preferred age group \>40 years)
• • Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion.
• • Informed consent
• Exclusion Criteria:
• • Under age (\<18yrs)
• • Active or recent (\<1 yr) septic arthritis of the involved knee
• • Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
• • (Severe) osteoarthritis in the involved or other compartments of the involved knee
• • Severe osteoporosis
• • MRI not possible (eg. due to pacemaker)
• • Marked valgus- or varus alignment (\>6 degrees)