By 2017, the U.S. market for ankle devices is expected to more than triple in size. Future growth will be driven by the penetration of three-piece mobile ankle devices, which are expected to outpace two-piece configurations and take procedures away from the ankle fusion surgery market. The current technological state of total ankle implants is not as mature as that of the established large joint market. The ankle is a challenging joint to replace because it does not have a large surface area like that of the knee joint; however it still requires a high degree of mobility to function properly. It must also be stable and mobile, which is mechanically demanding. Early implants had cemented metal talar and tibial components with polyethylene friction reducing surfaces. Later designs relied on implantations free of cement with natural bone growth to adhere to the implants. As with implants in other areas, lesser-constrained designs with mobile bearings are more technically challenging to develop but offer better replication of the body’s natural motion.

 

Another factor driving the market for ankle devices is the high incidence of diabetes in the U.S population. Diabetes has a harmful effect on distal extremities due to the systemic effect it has on the body’s circulation. In addition, diabetes adversely affects tissue when left unmanaged. The feet, being weight-bearing parts of the body, are also prone to ulcers, sores, and infection, thus increasing the need for foot and ankle surgeries. The incidence of diabetes tends to increase with both obesity and with age and as a result, the demand for foot and ankle surgeries is expected to increase as the baby-boomer demographic ages.

 

The U.S. market for external fixation devices is expected to steadily increase, reaching $345 million by 2017. As opposed to internal fixation, external fixation involves the stabilization of fractures by rods and pins that attach from outside the body to be anchored on rigid frames. External fixation is often preferred over internal fixation in cases such as open fractures with significant soft tissue damage where invasive surgery is contraindicated, multiple trauma sites that require immediate fixation, or when patients have insufficient bone stock. In addition, external fixation is less invasive than internal fixation because it does not require follow up surgery. Unlike internal fixation devices, external devices can also be reused and refurbished, provided they are properly sterilized. Approximately 16.3% of surgically treated ankle fractures are treated using external fixation, making this the second highest proportion of external fixation procedures performed amongst all anatomies. Significant benefits of external fixation include minimal invasiveness, lowered or eliminated blood loss, decreased operating times, earlier return to motion, and less soft tissue disturbance.

 

Recent advancements to pin coatings that prevent infection localized around the inserted pin are fueling the U.S. market for external fixation devices. The mineral hydroxyapatite, a naturally occurring compound in bone, can be used as a coating to promote bone growth around the pin-to-bone interface. Growth in the interface prevents the wiggling of pins and eliminates areas where bacteria can naturally grow. Additionally, bacteriostatic coatings, such as silver nitrate, can be applied to the surface of pins to prevent the formation of bacterial colonies, reducing the risk of infection.

 

Synthes, which was recently acquired by Depuy, held a large portion of the U.S. foot and ankle device market in 2010. It was the leader in the external fixation market, offering medium and small rod-like external fixators. In 2008, the company also introduced the Synthes Inventory Management System (SIMS), a program designed to allow organizations to manage Synthes branded inventory. An investment of this nature enables the company to retain brand loyalty in a time when competition in the fixation market is increasing.

 

In 2010, Stryker was another strong competitor in the external fixation market. The company’s purchasing agreement with the U.S. military and the success of its Hoffman external fixation system allowed for significant market growth. The Hoffman II system is an MRI-compatible system made of nonferromagnetic and nonconductive materials.

 

Wright Medical was the third competitor in the foot and ankle device market in 2010. The company’s revenue growth was driven by sales of the Charlotte (trauma fixation) and Darco (reconstruction and deformity correction) line of foot products. Small Bone Innovations also maintained a share of this market during 2010. The company received FDA approval for the mobile-bearing STAR total ankle device in early 2009. However, this regulatory approval was contingent on the monitoring of safety and effectiveness of the device; follow up studies will continue until 2017. The device has been available outside of the United States and has been implanted in more than 15,000 patients worldwide.

Information in this article is taken from a detailed and comprehensive report published by iData Research entitled U.S. Market for Small Bone & Joint Orthopaedic Devices 2011.