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Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
Lesions in the cartilage are common disorders. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis. Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2015-01
Completion Date
2028-12
Last Updated
2024-11-08
Healthy Volunteers
No
Conditions
Interventions
Follow-up of Episealer implant
Follow-up and radiographic evaluation in patients who received an Episealer implant
Locations (1)
UZ Leuven
Leuven, Vlaams-Brabant, Belgium