Components that make up the ankle joint can be divided into:
- Ligaments and Tendons
- Secure the joining of the bones and proper alignment, tendon provides muscle attachment.
- Facilitate the movement of the joint
- Vessels and nerves surround the ankle joint, delivering nutrition to the joint structures, and relay sensations to the central nervous system.
- Bony Structures
- Provide the skeletal framework of the joint.
The STAR™ Ankle is used world-wide for more ankle replacements than any other device. It has a long clinical history – the current design has been in use for over 20 years, and prior generations of the STAR were approved for use as early as 1978. The STAR is the only 3-piece mobile bearing total ankle available in the United States, as approval for such a device in the US requires a rigorous FDA PMA process that is very expensive and time-consuming. The process to get the STAR approved took nearly 10 years, and was approved in 2009.
The STAR has been well documented and analyzed in papers. 85% of papers analyzing commonly used total ankle devices in the United States focus on the STAR. One of the best ways to understand the effectiveness of joint replacements is to consider a statistic called the ‘survivability’ of the implant – which is the likelihood that a device will remain implanted for a particular number of years. The STAR has been shown in clinical papers to have a 90% likelihood to remain implanted for 10 years. No other total ankle replacement approved for use in the US has published any survivability information for their implants.