Osseointegration (OI) offers a groundbreaking approach to prosthetic limb integration, promising improved mobility and quality of life for patients. The bone-anchored limbs offer direct skeletal attachment, eliminating many challenges of conventional prosthetic limbs, including soft tissue irritation, unstable socket fits, and managing changes in limb volume. Perhaps the most remarkable observation from OI patients is that many regain a sense of proprioception, or the ability to perceive the position and pressure of their prosthetic limbs without visual confirmation, a phenomenon known as osseoperception.
The momentum around OI is accelerating the pace of education around protocols for evaluating candidates, as well as surgical, prosthetic, and rehabilitation considerations for patients with bone-anchored limbs. The emergence of organizations like the University of Colorado Hospital’s Bone-Anchored Limb Research Group (BALRG) are a testament to the profession’s desire to make OI accessible while ensuring successful clinical applications for optimal patient outcomes. Launched three years ago, BALRG’s mission is to perform impactful translational research to improve the lives of OI patients.
Jason Stoneback, MD, a key member of BALRG, is also chief of orthopedic trauma and fracture surgery and director of the Limb Restoration Program at the University of Colorado Hospital’s Anschutz Medical Campus.
“Our primary focus for OI is patients who are not thriving with traditional sockets,” he says. “These are often individuals dealing with soft tissue irritation, abnormal pressure, or poor prosthetic fit.”
Stoneback stresses that physiological readiness is just as critical. “We look for an environment where the bone will successfully integrate with the implant—any conditions like poorly controlled diabetes, compromised immunity, or inadequate blood supply would be contraindications.”
Additionally, CU’s interdisciplinary team ensures patients are physically and mentally prepared for surgery and have the necessary support in place. Rehabilitation takes a tailored and collaborative approach. Unlike traditional prosthetic rehabilitation, which often involves a long period of socket adjustments, tissue healing, and limb shaping, OI rehab builds on the patients’ preexisting body awareness and musculoskeletal system to achieve post-amputation stability.
“Surgery is done in a single-stage procedure,” Stoneback says. “After a couple of days in the hospital and a six-week healing period for the bone to grow into the implant, patients begin an intensive three-week physical therapy program.”
This rehabilitation focuses on balance training, osseoperception, and gradual weight bearing with crutches, eventually progressing to unassisted walking.
Stoneback’s team developed protocols to align implant loading and gait normalization to give patients the best possible results. Surgical precision and design ensure that even minor adjustments in alignment are carefully considered. Most patients achieve functional independence within three and half to four months after surgery.
“It takes a lot of experience and infrastructure to do this procedure and do it well,” Stoneback says. “Our mission is to educate, innovate, and teach. That fosters collaborative relationships where we can say, ‘Hey, I have a patient I want to send your way,’ and we can be confident they’re a good candidate before we even meet with them.”
Managing Risks and Complications
Instances of serious complications with OI are relatively low, however, the procedure is not without risks. Soft tissue irritation and infections around the skin penetration site are the most common complications. Still, advancements in surgical techniques have significantly minimized these challenges.
“We bring in plastic surgeons to optimize the soft tissue envelope during surgery, which is key to reducing complications,” he says. “The healing process transforms the skin site into a durable surface—similar to when you injure the inside of your cheek, it requires proper hygiene and care, but with that, it is fully manageable.”
OI patients at CU are carefully counseled about the trade-offs, too. The team ensures patients make informed decisions through educational classes, peer support from other OI patients, and detailed discussions about risks and expectations.
“Despite occasional setbacks, surveys from our Bone-Anchored Limb Research Group reveal that 100 percent of patients would opt for the procedure again,” Stoneback says, noting that this is a testament to its life-changing impact.
Interdisciplinary Care Drives Innovation
CU’s interdisciplinary team collaborates extensively to ensure patients’ journeys are as smooth as possible, from presurgery and rehabilitation through continued support living with their new bone-anchored limb.
Dan Milius, MS, CPO, works with Stoneback as part of the Limb Restoration Team at CU, and the interdisciplinary BALRG team. Like Stoneback, he understands the integral role of collaboration in successful outcomes. Team-based evaluation ensures comprehensive decision-making.
“We conduct a monthly OI clinic where new and returning patients meet each member of our clinical team,” Milius says. “At the end of the day, we review their cases together to decide if they are good candidates or if further screening is required.”
This approach includes input from orthopedic surgeons like Stoneback, and from nurse practitioners, prosthetists, physical medicine and rehabilitation specialists, and social workers. Patients also have the opportunity to engage with OI peer groups who can provide valuable perspective and support.
The role of interdisciplinary involvement in expanding OI knowledge and improving patient success cannot be understated.
“Communication among a clinical team for the betterment of patients increases positive outcomes substantially,” Milius adds. “Overall it works very cohesively—care isn’t delayed because communication is fast. It takes a village, and when more than one person is caring for a patient, the more likely they are to succeed.”
For Milius’ part, consulting experts in their respective fields allows him to stay focused on evaluating patients strictly as a prosthetist. Specifically, being able to fully understand what motivated a patient to have the OI procedure allows Milius to better address their needs with a bone-anchored prosthesis.
“Prosthetists need to understand this motivation when it comes to providing this level of care,” he adds. That high level of care includes focusing on issues with hip flexion contractures and bone alignment.
“Post-surgery, patients often see rapid improvements in hip extension as they adapt to the bone-anchored prosthesis,” Milius says. “Unlike socket patients, OI patients benefit from the lack of external forces, leading to reduced muscle tightness within months.”
This rapid evolution necessitates close monitoring and frequent adjustments to the prosthetic alignment. “Bone-anchored alignment evolves quickly, and we need to adapt just as fast,” Milius adds.
It’s important for patients to anticipate changes to their gait, too. They need to understand that the prosthesis they have now may not necessarily end up being the best solution. “I am a fan of things like foot trials so patients can experience different ones,” Milius says.
He shared his knowledge on special alignment considerations for bone-anchored prosthetic patients as part of a panel at the Academy Annual Meeting & Symposium in February. He believes this type of knowledge sharing is crucial to prosthetists.
“It’s easy to get isolated working at a clinical practice, so it’s important to go to conferences,” he says. “My colleagues and cohorts in OI want to talk about the things we see, and we’re trying to educate the rest of our industry on how to have successful fittings and provide the best care for these patients.”
Jason Hoellwarth, MD, is a limb reconstruction surgeon at the Hospital for Special Surgery (HSS). He is the only American surgeon to have completed an OI fellowship under the guidance of surgeon Munjed Al Muderis, a pioneer in the development of the Osseointegration Prosthetic Limb (OPL) connector. Hoellwarth has performed and assisted on more than 100 OI procedures. He is also the most published American surgeon on the subject of OI. His philosophy on the procedure balances optimism with prudence.
“I am open-minded because the potential for doing well with OI is very high, and the risk of negative outcomes is low,” he explains.
Hoellwarth and his team have conducted extensive research confirming the safety of this procedure. They published a study of 500 patients that showed a remarkably low mortality rate attributed to OI, with the few affected individuals having extreme comorbidities such as severe obesity or vascular problems. He highlights this as evidence of the procedure’s overall safety and potential to enhance mobility and quality of life for appropriate candidates.
While Hoellwarth believes there are more pros than cons to OI, he says surgeons also have a responsibility to ensure they aren’t making a patient’s life worse.
“Let’s say you’re doing well with your prosthesis, and you’re comfortable, you are doing all you want to do, and you feel satisfied with your life,” he says. “In those cases, the patient may not benefit from surgery since they are doing so well. However, sometimes patients have actually consigned themselves to life in a socket and may not realize they in fact have a lot of potential to gain by having OI. This is the importance of having a personal consultation with an experienced OI surgeon.”
Hoellwarth and Stoneback follow similar post-operative rehab timelines. Once an implant goes in, Hoellwarth’s patients are non-weight bearing for four to six weeks, depending on how healthy the bone feels and looks. Overloading the bone is not the primary concern, he says, but there are a variety of things that can be done to ensure success even for patients with thinner bones.
“It takes about six weeks for new bone cells to grow and that is why in other orthopedic scenarios, patients are casted or kept non-weight bearing for a similar amount of time,” he explains.
At that point, Hoellwarth says patients typically begin loading at 25 pounds per day for five minutes at a time, ten to 12 sessions per day, for a total of an hour or more, to simulate walking. Weight is increased by about five pounds per day and in another four to six weeks, patients are usually supporting their full body weight. Around the two- to three-month mark they are typically fitted with their full-sized prosthetic leg. He has seen patients with transtibial OI amputations walking out of the prosthetist’s office upon receiving their new prosthetic legs.
Preventing Complications
When it comes to risks and complications, Hoellwarth says it is important to distinguish what is an actual complication. “You have the implant coming through your skin portal and sometimes that skin can turn red,” he explains. “It’s most often not infection, but simply inflammation that causes this, which is usually resolved with some gentle skin care.”
Infection risk has drastically improved with enhanced hygiene practices and patient education, dropping to around 5-8 percent, with implant removal rates as low as 2 percent. By fostering awareness around proper hygiene and steering patients away from harsh cleansers, outcomes have steadily improved when there is good patient adherence. Hoellwarth emphasizes, “We’ve learned to diagnose and better prevent issues, which allows us to care for far-away patients remotely through telehealth methods such as image sharing and video calls.”
Hoellwarth ensures that patients can retain their local prosthetists, as the universal OPL connector works seamlessly with essentially all prostheses. “This is not an exclusive system—it’s a mounting point that remains adaptable to changes in the patient’s prosthetic needs,” he says.
Accessibility and affordability also remain central to his mission. Despite a lack of standardized surgical codes for OI, he says he and his team have had success appealing to insurance providers to secure coverage for the procedure, including Medicare and Medicaid patients, and has also cared for many international patients. He encourages patients from states and countries without experienced OI surgeons to reach out to him, as he has worked with the hospital’s Medicaid Access programs to provide OI care for out-of-state and international candidates.
The Prosthetist’s Role in Successful Outcomes
Haris Kafedzic, CPO, director of prosthetics, Eschen Prosthetic & Orthotic Labs, New York, has worked with more than 180 OI patients. “Initially, I like to provide them with as much information as possible on what their life will look like with a bone-anchored prosthesis,” he says.
When evaluating patient candidacy, Kafedzic’s main criteria is that the person has been unsuccessful wearing socket prostheses, whether because of infections, residual limb shape, or other issues. He has worked with some patients who have done OI as a first-line prosthetic solution as well. Following OI surgery, Kafedzic integrates a structured weight bearing protocol.
“When a patient gets an amputation with OI, they are non-weight bearing for about a month,” he says. “That is when they start loading their limb—generally with 20 pounds, five minutes, five to six times a day, and then increase by five pounds every other day. They do that for a month.” After this gradual phase, patients are typically fitted with their prostheses. The process from procedure to standing and walking takes around two to three months, he says.
The type of implant used, such as press fit, influences the surgical methodology but the weight-loading timeline is generally the same unless complications arise. Adjustments are made if a patient’s bone strength requires slower progression.
In addressing the differences of fitting OI patients with prostheses, he says the main contrast is that there is no socket to deal with. “With OI you can skip the socket part and just move on to the alignment,” he explains, adding that alignment is even more important when there is no absorption device to support the limb.
“As prosthetists we need to be diligent to make sure they have the best alignment possible, so it’s really important to spend more time on the alignment and consideration for the components more than a traditional prosthesis,” Kafedzic says. “And following up with the patients is critical because as they start putting more weight on their prosthesis, their gait changes, so microchanges in the alignment will make a big difference.”
Like the other specialists we spoke with, Kafedzic believes patient education is integral to helping them make informed decisions for better outcomes. “I treat OI education the same as an elective surgery consult and do my best to provide information objectively,” he adds. “Everyone makes decisions differently so we must avoid subjectivity.”
Kafedzic offers resources and information about different options. When the time is right, patients are introduced to others who have undergone OI procedures, but he stresses the importance of shared experiences being informational rather than directive. Ethical considerations are also addressed early on. “We have to make sure the patients understand that there may be some components or replacements that are not covered by insurance that patients may have to handle out of pocket.”
Kafedzic also stresses the importance of interdisciplinary care in achieving the best outcomes. He stresses that surgeons, prosthetists, physical therapists, and implant manufacturers all play essential roles. “We aren’t just treating a leg; we are treating the person, and the leg is simply a tool to help them achieve their goals,” he adds.
Psychological support is also key to treating the whole patient, Kafedzic says, particularly for those adapting to the challenges of life after amputation. And while surgical and technological advancements in OI continually evolve, his fundamental approach to care remains constant. “Advancements like better connectors or breakaway systems give us better tools, but they don’t change how I interact with the patient,” he says. Patient feedback also plays a role in refining care, with connections between practitioners, manufacturers, and patients fostering innovation.
In May, Kafedzic will lead a session at a one-day course taking place at HSS aimed at providing hands-on learning experiences. “It’s open to prosthetists and some physical therapists, offering credit courses and a chance to see these processes in action,” he says.
New Procedure, New Approach
Gerald Stark, PhD, MSEM, CPO/L, FAAOP(D), director of clinical operations and technical support, BionIT Labs, believes the complexity of OI demands a new paradigm in patient care, and stresses that OI care cannot be managed the same way as traditional prosthetic care.
One key difference is that the need for early involvement from prosthetists is pivotal. “Traditionally, prosthetists were approached after amputation surgery,” he says. “They should be involved from the beginning.”
Presurgical collaboration ensures informed decisions about component selection, alignment requirements, and long-term biomechanical considerations, he says, preventing the need to retrofit solutions after the fact.
Stark points to the ethical concerns that arise at the intersection of innovation and patient care. He believes practitioners must strike a balance between promoting cutting-edge solutions and clearly communicating the risks and responsibilities associated with new technologies. Prosthetists must serve as counselors, helping patients understand the implications of procedures, including potential complications such as infection or biomechanical challenges.
“An informed and patient-centered approach is imperative, especially as OI transitions from a niche treatment to a broader application,” he says. “The responsibility to evaluate each patient holistically—factoring in things like bone health, lifestyle, and long-term outcomes—illustrates the growing complexity of prosthetic care.”
Although standardization and interdisciplinary collaboration also play critical roles in the evolution of OI, Stark says that can be tricky in a competitive landscape like prosthetics manufacturing.
“There is this tendency with any new technology that the groups that introduce it want to be the sole owners of it,” he says. “But that doesn’t always best serve the patient if it prevents them from getting the solution they need.”
Surgeons, prosthetists, and manufacturers must work together to develop streamlined systems that ensure patient safety while advancing innovation. Stark says the field is moving toward a future that redefines the prosthetist’s role as not just a clinician but also a biomechanical and ethical engineer. This shift demands ongoing education, adaptability, and a commitment to excellence in both technical development and patient care.
“With OI, the alignment is totally different, so the prosthetist has to be a better engineer than they were before,” he says. “Some are ready and flexible to change, while some are not—and that’s what creates anxiety in the market. Some will choose to innovate, and some will not because they believe it’s too big of a risk.”
Insurance Challenges
With OI still being a new frontier in O&P, it requires different navigation in terms of insurance and accessibility, too. Stark says insurance providers want to see the value added to a patient’s life in terms of better outcomes.
“Surgeons and prosthetists need to tell that story of value,” he adds. “And we need to be in it for the long haul to do so.” Not only do prosthetists need to paint a picture of why a patient would benefit from a bone-anchored prosthesis, Stark says, but also a picture of the long-term benefits for the patient. These requirements will change the role of prosthetists, prosthetics manufacturers, and documentation coordinators going forward.
This new frontier will also change who is willing to provide these services and who is not, according to Stark. He cautions that those already in the profession will have to adapt to new processes for these patients or they will no longer be able to serve them. “I don’t necessarily look at innovation as good or bad, but it requires preparedness,” he adds. “And for OI we have to prepare differently and better.”
Kimberly Hoyt, CP, managed OI claims and reimbursements until 2023 and is now cofounder of OsseoCentric, Colorado. She knows well the challenges of billing and coding for OI and the impact they can have on providers deciding whether to provide OI care.
“More surgery centers are offering OI procedures, and more prosthetists are providing solutions, but there are still a lot of payers dragging their feet,” she says. “A new procedure (or HCPCS) code is available for connectors, but there is still a lot of murkiness around this.”
She says patient care considerations become even more challenging for prosthetists because there are many elements of that care for which no coding exists. Essentially, prosthetists are not recognized for the time, intensity, and skill required for the level of care they are providing.
These questions may be the catalyst for change that moves things in a more structured direction, ideally providing better insurance coverage for patients, and more clarity for care providers. “We have to bring the experience to the table with [the Centers for Medicare & Medicaid Services] to ensure we’re well represented,” Hoyt says. “Because it all comes down to the care and safety and education of the amputee.”
There is little doubt that the momentum around OI will continue. As it does, providers will keep learning how to best navigate the opportunities and challenges it provides. OI demonstrates the powerful intersection of surgical innovation, tailored patient care, and collaborative expertise.
“There is so much opportunity to learn through research and clinical guidelines, and there are still a lot of knowledge gaps to be filled,” Milius says. “It’s rewarding caring for these patients when things haven’t gone how they expected. They get really excited about OI, and we have the opportunity to meet them at that level of their anticipation and help them achieve the life they want to live.”
With continued advancements in OI and a commitment to patient-centered care, the potential for life-changing outcomes will undoubtedly grow, transforming what it means to live and thrive with an amputation.
Tara McMeekin is a writer and editor based in Colorado.
