In the past couple of years, there have been some new implants designs that have cleared the FDA process. These new implants have significant advantages over the previous devices, including ease of placement and refined instrumentation for accuracy of placement. All of the current US total ankle replacement designs - Trabecular MetalTM Total Ankle (Zimmer), InboneTM (Wright Medical), Salto TalarisTM (Tornier), and S.T.A.R.TM Total Ankle (SBi) are available through Dr. Stephen Frania, DPM.
Certain implants offer distinct benefits and should be selected based on specific patient criteria.
The Zimmer Trabecular Metal Total Ankle replacement system is an innovative design intended to replace the articulating surfaces of the ankle that have been affected by disease or injury. This system brings contemporary advances realized in knee and hip arthroplasty technology to total ankle arthroplasty while utilizing a lateral (side) surgical approach.
The Zimmer Trabecular Metal Total Ankle replacement system has been developed to give your surgeon an option for restoring natural movement to the ankle joint. Unlike other ankle replacement surgeries which use an incision on the front of the ankle, this procedure uses an incision on the side of the ankle, which is why it is called a lateral (side) approach. In this approach, the lower portion of the fibula is surgically moved to the side to perform the procedure and is later repositioned with a metal plate.
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.
Since its inception in 2005, the INBONE® Total Ankle System has continued to be the most distinctive and innovative total ankle replacement system on the market. By offering the first total ankle system that provides intramedullary instrumentation (utilizing the vertical axis of a patient's shinbone) for accurate component positioning and the first ankle prosthesis with a modular components for patient specific needs, Wright Medical continues to redefine innovation in ankle arthroplasty.
The INBONE® Total Ankle System is a modular prosthesis installed via the first and only intramedullary alignment - PROPHECY® INBONE®. This is a major advancement for precise, reproducible installation.
The INBONE® Total Ankle has many features that enhance its performance, including:
The Salto Talaris provides accuracy and reproducibility with the Precision Instrumentation that has evolved to allow a fixed-bearing implant design and represents the philosophy "Less is Sometimes More."
The Salto Talaris Anatomic Ankle is a new generation ankle replacement that mimics the anatomy and flexion/extension movement of the natural ankle joint, and is an alternative to traditional ankle fusion.
Advancements in orthopaedic technology continue to revolutionize surgical options. Today's surgical instruments and implants make orthopaedic surgery more precise and more effective than ever before. One such advancement can now be seen in the Salto TalarisTM, which has been modeled after the human anatomy and is positioned to redefine the classic approach to ankle arthroplasty.
The innovative Salto Talaris now provides surgeons with the ability to reproduce the natural flexion/extension axis of the ankle with an anatomic design. The Salto Talaris implant design and instrumentation is founded on the Salto mobile-bearing ankle prosthesis, which has been in clinical use since 1997 with a 93% survivorship at 6.4 year mean follow up2,3 and an 85% survivorship at 8.9 year mean follow up4. The Salto Talaris provides accuracy and reproducibility with the Precision Instrumentation that has evolved to allow a fixed-bearing implant design and represents the philosophy "Less is Sometimes More".
The Integra Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The prosthesis is composed of a tibial tray, a talar dome and an insert. Both the tibial tray and talar dome are secured to patient anatomy; the insert is rigidly fixed to the tibial tray intra-operatively. When all three components are implanted, the insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint.
Each of the three components is available in a variety of sizes and design configurations intended for both primary surgery and revision surgery applications.