With FDA approval in hand, this innovative surgery has made socket-free prosthetics possible for thousands of amputees. Is it the right choice for you?
by Rene Agredano
Lauren Malinowitzer never imagined she would spend an entire year sitting in a recliner, deeply depressed from an orthopedic surgery gone wrong. But dead nerves in her right ankle stole her mobility, and daily battles with chronic regional pain syndrome (CRPS) filled her with despair. During one especially bad morning in 2019, Malinowitzer felt the only way out of her agony was to stop living altogether. She wrote goodbye notes to her family and stashed them away. Then she went off to a medical appointment in Manhattan that changed everything.
“I was told I needed an amputation,” she recalls. “My leg was not salvageable.” She had expected that news, but she was surprised when her doctor explained that she still had options: She could have a regular amputation, or she could choose a new procedure called osseointegration (OI) that would have her up and walking in about 12 weeks if everything went well.
“I was like, ‘Twelve weeks?’” Malinowitzer laughs. “‘I’ve been in a chair for a year. That’s amazing!’”
Her subsequent experience showcases all the benefits of OI, a socketless solution in which the prosthetic limb is anchored directly to the bone in the residual arm or leg. Two months after her OI surgery, Malinowitzer was back on her feet; three years later, the 39-year-old motivational coach is back to living her best life. “I’m in such a different place,” she says. “It’s incredible.” She’s now traveling, taking long hikes, roughhousing with her young nephew, and enjoying most of the activities she did before CRPS. Because OI amputees have a heightened sense of proprioception, Malinowitzer can walk without constantly looking at the ground. And she has avoided the sores, skin problems, and nerve pain that so often plague socket-wearing amputees.
“It’s truly a blessing,” she says. “This leg is ready to go for anything. It never disappoints.”
Outcomes like Malinowitzer’s explain why interest in OI has been intensifying since the procedure was first performed in the US in the mid-2010s. However, these success stories also run the risk of creating unrealistic expectations. OI can impose significant physical, financial, and mental costs. It requires lifestyle changes and tradeoffs that not every amputee is willing to make. And for many patients, it’s not the best clinical alternative for supporting mobility (or dexterity, in the case of arm amputees), balance, and long-range health.
Only a few hundred amputees have undergone OI surgery in the United States. Even fewer have had OI performed as a primary procedure, as Malinowitzer did, concurrent with their limb-removal surgery. Most amputees receive the treatment many years after the initial amputation, seeking better outcomes than they could achieve with a socket prosthesis. Now that the FDA has granted approval for some forms of the procedure, the number of amputees who consider OI is sure to rise.
“Most patients are doing extremely well,” says Jason Stoneback, an OI surgeon and director of the Limb Restoration Program at the University of Colorado School of Medicine. “We’re making advances every day. But there are downsides to osseointegration. There’s risk of infection, there’s risk of peri-implant fracture, stoma or skin-penetration-site pain—a lot of these downsides can occur in varying degrees of severity. So it’s important to understand the alternatives.”
The Reality of OI Care and Costs
The FDA-sanctioned version of OI uses an implantation system called OPRA (short for Osseointegrated Prosthesis for the Rehabilitation of Amputees). A metal rod is threaded into the residual bone, and the opposite end protrudes through the skin, where it attaches to the prosthesis via specialized hardware. The FDA approval only covers lower-limb, above-knee amputees who are between the ages of 18 and 65, weigh 220 pounds or less, possess required levels of bone density, and meet other health criteria.
Other forms of OI, though not yet FDA-approved, are available overseas or in the US under special-use exemptions. Malinowitzer’s procedure used an OI anchoring system called press-fit, which involves an in-bone attachment similar to the ones used for hip replacements. Press-fit OI is very common in Europe and Australia.
Both forms are subject to similar complications, the most common of which is infection at the point where the metal rod emerges through the skin. To minimize the risk of infection, OI users must commit to a lifelong regimen of daily cleansing and care, and they’re advised to avoid bacteria-rich environments such as hot tubs, lakes, and public swimming pools. Yet even the most conscientious patients can end up with wound-care problems.
“I’ve had a few infections,” Malinowitzer says. “I’ve even had midline IV antibiotic put in. I’ve had surgery to clean it out. It’s still worth it. Nothing that’s happened would make me want to switch to a socket.”
“We accept that the stoma will be colonized by bacteria, but that doesn’t necessarily mean it will get infected,” adds Stoneback. “Some patients never have any infections. Some have a tendency to get superficial, soft-tissue infections, and we have a variety of ways to treat those, from more intensive stoma care to oral antibiotics to surgical debridement. And then we get into the realm of deep-seated infection, which is the real dreaded complication that can loosen the implant or even require explantation [removal].”
While the latter outcome is rare, surgeons generally don’t recommend OI for patients whose infection risks are too high. That includes many patients with diabetes. “We make sure their diabetes is well controlled,” says Stoneback. “You have to have very strict criteria.”
Another cost of OI that many patients don’t expect is the emotional impact. Dominic Maraglia, a 53-year-old software engineer who chose OI after years of frustration and pain caused by ill-fitting sockets, says nothing could have prepared him for the sensation of titanium metal touching the inner layers of his skin. Maraglia did extensive research about the procedure before committing to it. Even so, when his surgical bandages were removed to expose the OI rod protruding from his limb, he nearly blacked out. “It was really hard to look at, at first,” he recalls. “It’s super weird, and it did freak me out.”
The jolt was enough to make Maraglia second-guess his decision to have OI surgery. But he stayed committed to the program, gutted out the weeks of rehab and physical therapy, and eventually came to appreciate the exposed metal as a symbol of empowerment. “I love it because of what it gives me,” says Maraglia, who credits OI with helping him achieve the best physical and mental shape of his life. He travels globally and enjoys outdoor activities he could never pursue before, such as skin diving and hiking. “It doesn’t bug me at all now,” Maraglia says. “I look at it and think it’s cool.”
Like most prosthetic solutions, OI faces insurance gaps that can make it cost prohibitive. OI has only had limited FDA approval for about 20 months, so it’s not always covered. Even when it is, the prosthetic fittings and hardware designed for OI attachments can run into the tens of thousands of dollars, says Malinowitzer’s prosthetist, Erik Schaffer of A Step Ahead Prosthetics.
“The OI pieces are really, really expensive, and the insurance carriers won’t always pay for the parts,” Schaffer explains. “I can’t get half the stuff reimbursed.” Schaffer has been working with OI patients since the earliest days of the procedure, and he’s glad it’s becoming a realistic option for a growing number of amputees (both upper and lower limb). But he cautions that OI’s financial considerations must be addressed before surgery to give a reality check to potential patients and their providers.
Cindy Asch-Martin has become well acquainted with all of those costs—physical, emotional, and financial—since her OI surgery in November 2019. Because she has osteoporosis and other concurrent health problems, US surgeons regarded her as a poor candidate for success and declined to perform the procedure. She had the surgery done in Australia, paying out of pocket with generous support from a network of friends and family. Since then she’s battled major and minor infections, endured multiple debridements, recovered from a hard fall on the residual limb, managed ongoing daily pain, and even flew back to Australia for a surgical revision.
Despite all the setbacks, her enthusiasm for OI remains undimmed. “I used crutches for over eight years,” she says. “Between all the injuries and everything, I still believe that OI is a much better solution for amputees.”
Planning for Success
Sarah Smith, a physical therapist at the University of Delaware’s amputee clinic, says nobody should expect OI to provide a technological shortcut that solves all their challenges for them.
“The individual has to be motivated and ready to complete their exercise program to make gains and be successful in the long term,” she says. Lower-limb patients must relearn how to use their arms for balance while in motion, and even learn how to place equal amounts of weight on both limbs. “The priority is focusing on range of motion, strength, endurance, addressing any areas of pain, and educating the patient on skin care prior to surgery so the patient can have the best outcomes,” Smith says. “It’s a long process that requires commitment.”
Maraglia advises prospective patients to talk to as many OI amputees as possible and interview multiple medical teams before deciding on a provider. “Do not go to one doctor,” he says. “Do your research. I am so glad I got more than one opinion.”
Maraglia ultimately selected Stoneback, one of the most experienced OI surgeons in the United States. But with the procedure moving into the mainstream, many newer OI practitioners haven’t shepherded a substantial number of patients through the full treatment arc. They also may not have established relationships with prosthetists, physical therapists, wound-care specialists, and other clinicians who play a vital role in ensuring post-surgical success.
“We know the outcomes are better with multidisciplinary teams, where you have all the components that you need,” Stoneback says. In addition to an experienced surgeon, a full-service OI team should include a physical medicine and rehabilitation physician who is well versed in the nuances of recovery from OI surgery, as well as a prosthetist who understands the differences in function and gait between an OI prosthesis and a socket-based prosthesis.
“Let’s use a high transfemoral amputee as an example,” Stoneback says. “They often have flexion and abduction contractures in their socket, and prosthetists accommodate that deformity when they build a socket prosthesis. With osseointegration, we actually stretch those muscles back out and get the patient’s skeleton to become realigned. We’re getting rid of contractures. If a prosthetist has never had an OI patient or hasn’t had them in large numbers, they may not feel the patient is making the progress they want to see.”
During the initial recovery phase, Stoneback’s team works exclusively with prosthetists who are well versed in OI. But he encourages patients to get their regular prosthetist involved over the long haul. That way, expertise is bound to expand as the OI patient population grows.
Prosthetists like Schaffer think it’s moving in the right direction. He cautions potential patients to look extensively before they leap into OI, but he has also seen the procedure’s transformative effects on amputees. And he’s excited about where things may be headed in the future.
“I think the future with OI is smart abutments and neurobionics,” he says. “Full integration is where we are going to go. We will be building people fully integrated with computers and Bluetooth. They are going to take away the variable of having a socket. We are going to be able to produce some very unique prosthetics and a total restoration of life.”