FDA Approves New Implant for Painful Ankle Arthritis

May 31, 2009
STAR Ankle Implant

STAR Ankle Implant

T he U.S. Food and Drug Administration has approved the Scandinavian Total Ankle Replacement (S.T.A.R.) System for patients with arthritic or deformed ankles.

The S.T.A.R. Ankle, developed by Small Bone Innovations of Pennsylvania, relies on bearings that move across a surface of flexible plastic. The device was designed as an alternative to traditional fusion surgery, in which the shin bone is cemented to the talus bone in the ankle.

Fusion surgery typically stabilizes the ankle, but reduces the foot’s range of motion. The S.T.A.R. device may allow for greater rotation and movement in the ankle. It is the first and only FDA-approved device of its kind.

A two-year study of more than 200 patients found that the S.T.A.R. ankle had the same incidence of adverse reactions, follow-up surgery, and complications as fusion surgery. As a condition of the approval, Small Bone Innovations will evaluate the safety and effectiveness of the device over the next eight years.

Article Source: One Med Place

 

Dr. Nirenberg’s Comments:

Many people suffer with painful arthritic and weak ankles and for most, conservative methods can successfully alleviate their pain or weakness.

However, some people do need something more done for their painful ankle, such as a fusion of the ankle joint or an ankle joint replacement.

This new implant may turn out to be a good tool in our treatment arsenal. Previous ankle implants have not been too impressive, and time will tell if this replacement is really as good as it claims.