Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant (NCT03755388) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
Belgium4 participantsStarted 2018-09-20
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)