Evaluation of a personalized knee implant for cartilage damage
Long-term Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
This study is testing a custom knee implant to see if it can help people with cartilage damage feel less pain and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT03755388 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy, safety, and performance of the Episealer® device, a personalized focal knee resurfacing implant designed for patients with cartilage lesions in the knee. The study will involve 30 patients and will follow them for a long-term period of 10 years. The implant is customized based on MRI images to match each patient's joint anatomy and the specific characteristics of their cartilage injury. The goal is to alleviate pain and improve the range of motion for patients suffering from focal cartilage defects.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with focal cartilage lesions in the distal femur who have not benefited from previous biological surgical methods.
Not a fit: Patients with severe osteoarthritis, untreated ligament or meniscal issues, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with knee cartilage damage.
How similar studies have performed: While there have been various treatments for cartilage lesions, the personalized approach of the Episealer® implant represents a novel method that has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Hilde Vandenneucker, MD, PhD — UZ Leuven
- Study coordinator: Lore Hermans, MSc
- Email: orthopedie.research@uzleuven.be
- Phone: +32 16338818
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.