Status:
RECRUITING
Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Cartilage Damage
Knee Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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).
Detailed Description
Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03755388
Start Date
September 20 2018
End Date
December 1 2034
Last Update
November 8 2024
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000