Study Shows Improved Patient Outcomes for Episealer Knee Implant

Episurf Medical announced that results from a clinical study with follow-up of the 30 first patients from nine Swedish clinics show good implant safety and significantly improved patient-reported outcome scores with the Episealer Knee implant. Follow-ups of the patients are now completed, and the principle investigator will compile the results for submission to a scientific journal. In total, 30 patients are included in the study and the average follow-up time is 55 months (24 to 86 months).
 
The Episealer Knee implant is intended for treatment of focal cartilage and osteochondral defects on the femoral side of the knee joint. These defects often imply severe pain, which significantly can impact the patient’s quality of life. Cartilage has a very limited ability to heal and the self-repairing mechanism decreases further as we age. Current standard of care, which includes various biological treatment alternatives, have shown limited effectiveness, especially with increasing age.
 
The Episealer Knee implant is fully tailored to fit each patient’s unique curvature of the joint surface, the size and shape of the lesion, and underlying bone conditions. In addition to providing an individualised implant, individualised surgical instrumentation is also provided to enable correct position of the implant. The associated imaging technology visualises chondral and osteochondral defects and provides the surgeon with support in the decision making as well as being a surgery planning tool.
 
The objective of the prospective consecutive cohort study is to assess subjective short-term outcome and possible longer-term risks of the intervention. The study performed at Capio Artro Clinic, Stockholm, reviews the clinical outcome of 30 patients, from nine Swedish clinics, who have received an Episealer Knee implant during the years 2012 to 2017. The mean follow-up time is 55 months. Of the 30 patients, one patient has undergone revision to a partial knee prosthesis. The patient-reported outcome scores EQ5D, VAS (EuroQoL Visual Analogue Scale), VAS-pain (Visual Analogue Scale) and KOOS (Knee injuries and Osteoarthritis Outcome Score) all show significant improvements.
 
“This is the third clinical study from which we see clinical results. To date, only one of them have been published, but as previously communicated, we are expecting plenty of activity from this field during 2020. We are very happy to hear about the positive results from this independent study. The results are in line with the strong data presented from an ongoing European multicentre study, and further, confirms the results we get reported from individual surgeons who follow their patients. It takes time to get long term results and we have now come to a time point when these anticipated results can be presented, and hopefully, soon published,” said Episurf Medical CEO Pål Ryfors.