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Clinical Trials in Belgium / NCT03755388
Active, not recruiting Not applicable

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

NCT03755388 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Not applicable
Started
2018-09-20
Last updated
2026-03-09

Condition(s) studied

Cartilage DamageKnee Injuries

Investigational drug(s) / intervention(s)

Episealer

Episealer: Placing Episealer device

Study summary

The goal of this study is to evaluate the efficacy, safety and performance of the Episealer® device in a sample size of 30 patients and on the long term (10 years follow-up).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Vlaams-Brabant

More Universitaire Ziekenhuizen KU Leuven trials in Belgium

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Other trials for the same condition

Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery Recruiting
A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03755388 on ClinicalTrials.gov ↗ ← All trials in Belgium