In 2013, the United States began to experience the advent of osseointegration (OI) within North America.
Various US Food and Drug Administration (FDA) rules have helped to facilitate use of the technology, some of which were accomplished with the use of humanitarian device exemption (HDE), custom device exemption (CDE), unique approvals, as well as within the military healthcare system. Several US-based healthcare centers—including the University of Colorado (UC) School of Medicine and UCHealth, Aurora, Colorado—are currently offering the procedure under these various pathways.
Recently, however, we saw a shift when Integrum AB, Mölndal, Sweden, received pre-market approval, which has made its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System available to a much wider market.
Today, things are rapidly changing, as several manufacturers are actively seeking to conduct studies under an investigational device exemption (IDE), as well as through 510k approvals (predicate devices), which will eventually enable additional devices to become commercially available within the US.
It is exciting to ponder how healthcare centers within the US are offering the procedure using the various devices that are available. More importantly, however, is that insurance companies are covering the procedure, including Medicare.
In 1990, the first successful osseointegration surgery was performed in Sweden by Rickard Branemark, MD, using the OPRA screw fixation device from Integrum; the device was based on proven dental implant technology. In 1999, the Endo-Exo press fit device was developed in Germany, simulating joint replacement technology. The Endo-Exo device was a collaboration between an engineer and a German surgeon, Horst Aschoff, MD, who implanted the first patient that same year.
In time, other surgeons began using the technology, but it took another ten years before it began to take significant hold in healthcare centers throughout Europe, Australia, and South America. Today, we see OI centers spread worldwide and it is rapidly becoming more accepted as a viable alternative to socket-based technology, even here in the United States. In early 2013, Lor Randall, MD, performed the first OI surgery in the US on a Canadian patient, using the compress device by Zimmer/Biomet. That same year, Ronald Hillock, MD, performed the first press fit OI surgery in the country, using the Longitude stem by Signature Orthopaedics. By 2015, Integrum had obtained approval under an HDE, which enabled it to offer the procedure to many more individuals with amputations than the other pathways allow. FDA approval was also granted that year for a University of Utah two-year, ten-patient study on US veterans, using the DJO developed POP press fit device.
In 1985, I had a transfemoral amputation, and after 28 years using a traditional socket, I traveled overseas to undergo OI surgery. Shortly thereafter, I started working for a foreign OI team, which allowed me to increase my knowledge base in the field and work with many leading surgeons, prosthetists, and patients, abroad and within the US.
Given today’s opportunities, seeking surgery abroad would not be my only option. I view the technology as a viable option for others with amputations to consider, although not as an outright replacement to traditional socket technology. Increasing awareness and knowledge on both the benefits and complications surrounding osseointegration is something that will help better serve the amputee community.
Fred Hernandez, president of AmpUtek, Las Vegas, manages a medical device distribution company that specializes in OI implants and related components. He began working independently in the field in 2012.
For more information, visit UCHealth’s Limb Restoration Program: Returning Patients to Their Optimal Self and
FDA Approves OPRA Implant System.
