In November 2017, Episurf Medical announced that a peer-reviewed article with clinical data on 10 Episealer® knee implant patients with 24 months’ follow-up was accepted for publication.
The publication with the title “No implant migration and good subjective outcome of a novel customized femoral resurfacing metal implant for focal chondral lesions” by Stålman, A., Sköldenberg, O., Martinez-Carranza, N., Roberts, D., Högström, M. and Ryd, L. will be published in the journal Knee Surgery, Sports Traumatology, Arthroscopy.
The study behind the publication is a multi-center clinical study conducted in Sweden with Dr Anders Stålman as principal investigator. The surgeries were performed between 2012 and 2014. The patients were followed-up with subjective outcome measures (VAS, Tegner, EQ5D and KOOS) and implant fixation was studied with RSA. The subjective outcome measures showed improvements that reached significance for VAS (p=< 0,001), Tegner (p=0,034) and the KOOS sub-scores Activities of Daily Living (p=0,0048), Sport and Recreation (p=0,034) and Quality of Life (p=0,037).
“This first publication from a clinical multi-center study with Episealer®, a customized focal knee resurfacing system, shows short-term implant safety and the patient related outcome measures show good to excellent results” says Anders Stålman, PhD, Senior Consultant, Capio Artro Clinic, Stockholm.
“This publication is very welcome for us, as high-quality peer-reviewed clinical evidence is a must for orthopaedic surgeons in their treatment decisions. This is a further and very important step forward to gain market shares for the Episealer®” comments Pål Ryfors, CEO, Episurf Medical.