THURSDAY, May 28 (HealthDay News) -- A total ankle replacement system that may preserve some range of motion in arthritic or deformed ankles has been approved by the U.S. Food and Drug Administration.
The Scandinavian Total Ankle Replacement (STAR) system is the first of its type and uses bearings that move across a surface of flexible plastic (polyethylene).
Total ankle replacement is considered when arthritis or injury has destroyed the cartilage that cushions the ankle bone.
The new device offers an alternative to fusion surgery, in which the shin bone is cemented to the talus bone in the ankle. While fusion surgery stabilizes the ankle, it significantly decreases a patient's ability to move their foot up and down.
"This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle. For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.
The FDA's approval of the STAR system is based on a two-year study of 224 patients that found the device had similar rates of adverse events, surgical interventions and major complications as fusion surgery. As a condition of the approval, Small Bone Innovations of Pennsylvania will evaluate the safety and effectiveness of its device over the next eight years.
Other options to fusion surgery include several fixed-bearing devices in which the articulating surface is molded, locked or attached to one of its metallic components.
SOURCE: U.S. Food and Drug Administration, news release, May 27, 2009