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Moving Out of the Socket and Into Innovation: Revolutionizing the Standard of Care for Amputees

Losing a limb is a life-altering experience. It comes with new daily challenges that amputees must learn to navigate while trying to cope with the loss of a body part. From discovering how to be mobile again to understanding new pains to overcome mental health hurdles, amputation is not just a surgery, it’s a journey.

In general, there are three main types of amputations: trauma-based amputations; amputations in response to diabetes, peripheral vascular disease and infection; and amputations brought on by cancer. Most procedures are lower extremity amputations. In the U.S. alone, the Amputee Coalition of America estimates that there are 185,000 new lower extremity amputations each year out of an estimated population of two million amputees. With the prevalence of lower limb amputations, the industry is rife with innovation regarding surgical techniques, rehabilitation and more. 

So, why has the standard of care for amputees not innovated past the socket prosthesis?

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A socket prosthesis is the traditional device that joins one’s residual limb to a prosthesis. Sockets are individually fitted to an amputee and many people live happily with this solution. However, others experience side effects such as volume fluctuation, which can lead to fit issues, skin breakdown, pain throughout the body and even fracture in the residual bone.

An Implant System That Attaches the Prosthesis Directly to Your Skeleton

Many patients find that the previously mentioned side effects cause them to lead an uncomfortable and painful life with less overall mobility. In fact, some amputees will choose to wear their prosthesis less often than they would like to because of the challenges. For those who struggle with the traditional paradigm, there is the OPRA™Implant System.

The OPRA™ Implant System is a technique in which a titanium implant is attached directly to the residual bone. The implant fuses to the bone through osseointegration, creating an opportunity for a prosthesis to support the individual from the musculoskeletal system instead of the soft tissue system, as would be seen with a socket prosthesis. After careful healing and rehabilitation, the prosthesis now acts as an extension of the patient’s body and mind.

Osseointegration was discovered in the 1960s when a Swedish physician, Per-Ingvar Brånemark, found that a titanium implant would integrate with the bone through a process he called osseointegration.  This practice was the foundation for modern-day dental implants, and it was brought to amputees for the first time in 1990. Dr. Branemark and his son, Dr. Rickard Branemark, formed Integrum to offer the revolutionary OPRA™ Implant System technology to amputees worldwide.

Patients Can Feel the Difference

The OPRA™ Implant System is the first and only FDA-approved bone-anchored technology for amputee care in the U.S. With the use of this system, hundreds of patients can experience: 

  • Reduced pressure, sores and pain.
  • Improved mobility and function.
  • Ensured stability without the need for additional tools.
  • Enhanced comfort.
  • The ability to live a more active lifestyle.

Issues with residual bone breakage have also been reduced thanks to breakaway features that ensure the prosthetic limb is never putting pressure directly on the residual bone in the case of unnatural movements. Additionally, thanks to osseoperception, amputees can feel a direct connection through the OPRA™ Implant System to the surface they’re walking on, knowing without having to look down if the surface beneath them is gravel, grass, carpet or more.

Roadblocks to Adoption

The biggest barriers to widespread adoption of bone-anchored prostheses are a lack of awareness and several misconceptions. Though many physicians, prosthetists and other clinicians have heard of this system, many still believe it is an experimental technology. But this is a solution that has 32 years of clinical experience behind it, peer-reviewed publication support and a wealth of data, including a five-year follow-up study that was used to gain pre-market approval (PMA) by FDA in December 2020.

There are also many misconceptions about the procedure’s risk and rate of infection. While there is a risk of infection with any surgery, and particularly any implant, the majority of those that have resulted from the OPRATM Implant System have been mild, superficial and easily treatable with antibiotics. 

Misconceptions aside, the biggest barrier to entry at this time is a lack of awareness in the patient community. Making patients more aware of this technology through amputee advocate groups, general publicity and other educational opportunities will allow them to take their quality of life into their own hands and determine if the OPRA™ Implant System is the right solution for them. 

A Look into the Future of Bone-Anchored Prostheses

There is still much to be accomplished in this space, and it all must be approached through science and evidence. Research and development, as well as clinical research utilized to continually validate this technology, will be essential to the growth of bone-anchored prostheses.

Additionally, it’s important to look at ways to make this technology easier to integrate into the hospitals and programs that want to adopt it. Creating more robust programs and facilitating education for surgeons, clinicians and rehabilitation centers will make introducing the OPRA™ Implant System seamless.

As of right now, the OPRA™ Implant System is only approved for transfemoral amputations in the U.S., but the technology’s capabilities far surpass that. Moving forward, FDA approval for transhumeral and transtibial amputations will be essential to serving more of the amputee community.

Thomas Dugan is President of Integrum, Inc.

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