Encore Medical
This article was originally published in The Gray Sheet
Executive Summary
Receives FDA go ahead to begin product development protocol for ceramic-on-ceramic hip implant. One thousand patients at 13 U.S. sites will be enrolled in two studies involving both a cementless and a hybrid (cemented stem/cementless acetabular component) version of the implant, which will be compared to a ceramic/polyethylene acetabular insert. Enrollment is expected to take 12-18 months, followed by a two-year follow-up period