Application

An intra-articular alignment guide for ankle replacement system to treat ankle arthritis.

Key Benefits

• Less invasive method that does not require drilling a hole through the heel for Inbone II tibial stem placement.
• More convenient to use compared to Inbone II frame and foot holder to find the correct alignment.

Market Summary

Approximately 1% of adults suffer from ankle arthritis. The condition is prevalent in the older population after a lifetime of ankle use and occasionally affects people under 40 years of age who have suffered an ankle injury in the past. About 18% of people over the age of 65 have degenerative changes in their ankle joints. Ankle arthritis is a debilitating clinical condition that causes painful swelling and inflammation in and around the ankle joint, causing difficulty in walking. For patients who do not respond to non-operative treatment such as pain medication, physical therapy, and supportive braces, there are two surgical options available. The first option is ankle arthrodesis or fusion surgery; this procedure is long-lasting and durable but allows limited ankle joint motion and elevates strain in adjacent joints. The second option is total ankle arthroplasty or joint replacement surgery in which the damaged ankle bone is removed and replaced by a metal implant. The older designs for this procedure were limited by the high failure rate and post-operative complications. Currently, there is only one ankle replacement system available in the market that allows for intra-medullary stem fixation into the tibia. As the rate of incidence of primary surgeries and revision cases increases, there is an unmet need for more revision ankle replacement systems and improved techniques that are less invasive.

Technical Summary

An Emory University researcher has developed a proposed device, an intra-articular alignment guide that provides accurate alignment for tibial stem implantation without having to drill through the subtalar joint and requiring a large foot holder and frame. The guide is placed into the ankle joint and locked in once the center-center location for the stem is obtained. A flexible drill bit and reamer system are used to create a path for tibial stem placement. This would be the first and only ankle replacement system that utilizes an intra-articular alignment guide and the second revision ankle arthroplasty system available.