Procedure Brings Hope but Comes With Challenges
By Mike Crist, Editor
“Now the word is out,” Dr. Joseph R. Hsu, orthopedic surgeon and vice chair of quality with Atrium Health’s Musculoskeletal Institute and associate dean for research at the Wake Forest University School of Medicine said.
He was talking about osseointegration, an alternative method of attaching a prosthetic limb to an amputee’s body. It refers to a direct connection between human bone and an artificial implant.
The procedure affixes a titanium anchor directly to the bone so that it extends out of the residual limb. The prosthesis attaches to the extension, also called the abutment.
Osseointegration gives hope to people who struggle with wearing a conventional socket, but it comes with some risks and barriers to accessibility.
Currently, most prostheses are mounted on a socket that fits over the residual limb.
Dr. Hsu has been paying attention to developments in osseointegration for 15 years. He has been performing the procedure since 2019.
He is excited about the future of osseointegration.
“It is growing,” said Dr. Hsu, who graduated with honors from the United States Military Academy at West Point and spent much of his military career working to improve outcomes for limb reconstruction patients.
“It is a very common request for people who want to come to see about doing the procedure and standing up a program like ours. We are receiving more and more of those requests, and not just from physicians but from prosthetists, therapists, advocates, and other people who want to find out about it.”
Although osseointegration has become more widely known and is being performed more frequently in the United States, Dr. Hsu still must deal with one persistent myth about the procedure. Many people think it is experimental.
This stems from the fact that osseointegration’s origins were in Europe. Many Americans have gone overseas to have the procedure done, and some are still doing that today.
“I hear that ‘osseointegration is still experimental’ a lot,” Dr. Hsu said, “but we have 20 years of peer-reviewed, published data. There actually is a lot of clinical data now available, and there are significant patient advantages based on that data. Additionally, the product that we use has been approved by the [Food and Drug Administration] for clinical use in the USA, and to get a product approved by the FDA, a lot of research, testing and clinical data first has to be submitted, reviewed, and accepted by the FDA’s expert reviewers.”
Another barrier has been cost, which is initially higher for osseointegration than for socket-based prostheses. However, Dr. Hsu said, it is a matter of cost versus affordability. Osseointegration is becoming more accessible to people who have insurance coverage. He expects that to continue as data is now becoming available on the economic quality-of-life improvements for patients with osseointegration over their lifetime.
“We continue to work with health systems and insurers to find pathways to accept and have this done with patients who have health insurance and who have an average income,” he said.
As with any medical procedure or product, there is a need to balance the cost of the procedure with the benefit to the individual patient and to society in general.
A key benefit that osseointegration provides is the ability to translate the patient’s muscle power to the prosthesis. “When they move their femur, the prosthesis moves,” Dr. Hsu said, referring to transfemoral (above-knee) amputation patients.
This can lead to the patient using the prosthesis for longer periods than patients with one that is socket-based.
Patients with upper-extremity amputations can see their ability to move their arms above their head improve.
“Their overhead ability is limited by the quality of their shoulder rather than the quality of their prosthesis attachment to their limb,” Dr. Hsu said.
The Amputee Coalition’s fact sheet about osseointegration lists other potential pros to the procedure: more stability when walking and standing; the ability to walk farther; fewer associated skin problems than with sockets; and ease of removing and replacing a prosthesis.
“Many amputees who have undergone osseointegration feel what is known as osseoperception–the sensation that their prosthesis is an actual part of their body,” the fact sheet says. “This helps many people overcome a psychological hurdle that prevents them from regularly wearing their prosthesis.”
Because it is a surgical procedure with significant recovery time, osseointegration also brings its unique risks.
There is the possibility of superficial skin and deep-tissue infections. “Infection is probably the biggest concern,” Dr. Hsu said. “We continue to work on ways to mitigate infection, ways to prevent infection. Surgical technique and product design play a key role in reducing the potential for infection.”
Other cons include the need to clean and maintain the skin and the interface between the implant and the skin regularly, the potential for the abutment to bend or break, hair in-growth, and limitations on participation in high-impact sports.
Dr. Hsu said one of the most important factors in determining whether to perform osseointegration is the activity level the patient hopes to reach.
“If you are a patient that is active or has the desire to be active,” osseointegration could be a good choice, he said.
Of course, everyone should always discuss their individual considerations with their own doctors before deciding about a course of action.
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