Three Erie County Medical Center surgeons worked with Swedish medical device company Integrum AB to install a technologically advanced implant into two patients from Western New York who have had a leg amputated above the knee, improving their mobility and lowering their risk for infection. They are, from left, Drs. Mark Burke, Thom Loree and Mark Anders.
Human clinical trials should start in Buffalo next year on a promising medical device designed to revolutionize orthopedic care.
“In terms of joint replacements, this is huge,” said Dr. Scott Nodzo, an orthopedic surgeon who expects to launch human clinical trials of BioPrax this year.
If things go as hoped, BioPrax could become the new standard for treating joint replacement infections by 2025. But Garwood Medical Devices, the company that makes it, already has built an important connection that put two men with leg amputations on the verge of greater mobility.
A surgical team at Erie County Medical Center began the process last fall to install prosthetic implants into a military veteran who lost part of his right leg in the Middle East and another patient whose leg was amputated after a motorcycle crash.
The implant both received can be used with a prosthetic limb to improve movement for many patients who have had a leg removed above the knee.
“We need background research on how to prevent infection, but also how to treat infection, and that’s why Garwood Medical is in the sandbox with us here,” said Dr. Rickard Branemark, who developed the implant in Sweden.
Branemark came to Buffalo in late September, and again earlier this month, to teach the ECMC surgical team how to install the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
The first procedure was performed 31 years ago in Sweden. More than 500 have since been performed globally, including 65 during a U.S. clinical trial of wounded combat veterans, mostly at Walter Reed Military Center in Bethesda, Md.
The Food and Drug Administration approved use of the OPRA system in December 2020. ECMC is one of the first American hospitals to offer it.
“This is a very unique procedure and it's going to change lives,” Dr. Thom Loree told The Buffalo News during an interview with the team.
Loree is chief of the ECMC Department of Head and Neck Surgery and Plastic and Reconstructive Surgery. He worked with Dr. Mark Anders, who directs orthopedic trauma care at ECMC and specializes in trauma-related reconstruction, as well as Dr. Mark Burke, also a plastic and reconstructive surgeon.
Dr. Rickard Branemark, an orthopedic surgeon who invented a novel implant for those with leg amputations above the knee, was in Buffalo in September and earlier this month to show a reconstructive surgery team at Erie County Medical Center how to install the OPRA Implant System.
OPRA implantation involves two surgeries based on osseointegration, a process through which a prosthesis is directly attached to a bone.
During the first two procedures last fall at ECMC, the surgical team implanted the screwlike end of the titanium implant, called the fixture, into the center of the femur on the amputated leg of both patients. It takes up to six months for tissue to grow and firmly anchor the fixture into the thigh bone, and for the surrounding skin to heal.
Branemark returned to Buffalo Feb. 3 to lead the next phase, in which the amputation site for both patients was prepared to accept a specialized connection implant component, called the abutment, which can be connected to the fixture. The abutment extends through the skin at the amputation site and allows a firmer, more comfortable attachment to an artificial knee joint, leg and foot.
Intensive rehabilitation therapy will follow another week or two of rest. Within several months, Loree said, both patients will have a much easier time walking – and even running or riding a bike should they choose.
“The big impact is really six to 12 months down the line,” said Anders, the orthopedic surgeon who leads the ECMC team.
The OPRA Implant System works similarly to a dental implant. One end of the device is screwed into the center of the femur and the other end protrudes through the amputation site, where it can be attached to a prosthetic leg, affording better mobility.
Standard joint replacements have saved many from amputation during the past half century, but trauma and chronically poor circulation still account for tens of thousands of cases annually in the United States alone.
Branemark heads Integrum AB, a Swedish medical device company. Its data shows that about 2 million Americans have had a limb amputated. Roughly 85,000 new amputations are performed every year, including for about 7,000 people who would be eligible for the OPRA implant.
“The surgeries are applicable to people who have been living with compromise for a long time, so it's not just the annual rate, it's the backlog,” Anders said.
The OPRA Implant System replaces traditional socket leg prosthetics by better anchoring an implanted medical device above the knee and an attachment outside the amputation site, providing greater mobility.
Those eligible to receive the OPRA implant must be 22 to 65 years old with leg amputations above the knee due to trauma or tumors. Those older, with vascular conditions, are ineligible.
Specialists at East Coast Orthotic and Prosthetic, as well as Tonawanda Limb and Brace, recommended the first two patients for the ECMC surgeries.
Those with such amputations typically use a socket prosthesis fastened with leather straps and a suction cup, which can cause excessive friction and pain, and raise the risk for infection.
“It can be very difficult to walk,” Loree said. “It takes tremendous discipline. It takes a tremendous amount of energy. This is going to be much more natural.”
“The goal is to have a reliable knee joint,” Branemark said. “Below the knee, you have more bony structures. It is easier for a socket to really grasp around it.”
He compared the result to the difference between dentures and implanted teeth.
“Dentures wobble around, they fall out,” he said. “When you use a socket prosthesis, it's sweaty. You get skin sores and pain and it's not really reliable. You get these implants and then suddenly the prosthesis will sit perfectly, and you can use it fully.”
Branemark knows of what he speaks. His father, surgeon and researcher Per-Ingvar Branemark, invented the current global standard for dental implants in Sweden in 1965 by using pure titanium screws he termed “fixtures.”
“Rickard is doing a similar thing, but with arms and legs,” said Mark Ehrensberger, associate professor in the University at Buffalo Department of Biomedical Engineering and director of the Kenneth A. Krackow Orthopaedic Research Laboratory in the university’s Jacobs School of Medicine and Biomedical Sciences.
“When patients get the new leg,” Branemark said, “they’re really happy.”
Dr. Thom Loree, chief of the ECMC Department of Head and Neck Surgery and Plastic and Reconstructive Surgery, learned about the OPRA Implant System through a Tonawanda prosthetics company and worked to connect its inventor, Dr. Rickard Branemark, with Garwood Medical Devices and University at Buffalo researchers working on related implant technology.
Branemark has served for several years with Ehrensberger on a U.S. Department of Defense Osseointegration steering committee designed to help improve the lives of U.S. servicemembers who have lost limbs.
Ehrensberger co-invented the patented technology behind the BioPrax system that Garwood Medical is testing to treat joint replacement-related infection, which has interested Branemark since the Swedish orthopedic surgeon learned about it six years ago during a DoD committee meeting.
BioPrax uses the implant itself, turning it into a low-voltage electrode. A thin needle makes contact with the implant, causing an electrochemical reaction that lowers acidity, boosts pH and creates antimicrobial activity around the implant.
Garwood spent the last four years improving its device as it prepares for safety and efficacy trials for knee replacement patients who develop infections.
Branemark believes the therapy may also treat – and possibly prevent – infections at amputation sites, a stubborn problem for many who learn to live with a prosthetic limb.
He became an investor in Garwood Medical, which during the last year raised more than $7 million toward research and development for the work.
Loree, the ECMC surgeon, learned about OPRA implantation through Tonawanda Limb and Brace, then set out to build a bridge between the hospital and Branemark. Meanwhile, the Swedish surgeon had became more interested in the potential for BioPrax to be used for better infection control with his OPRA implant. A larger collaboration quickly emerged.
The clinical experience of the ECMC surgical and rehab team, greater emphasis of medical entrepreneurship in Western New York, and manageable access to patients from several metro regions cinched Buffalo as a hub to start growing the OPRA implant surgical procedure across the Northeast and Midwest.
“We’re very excited about this,” Loree said.
Ehrensberger, along with Dr. Thomas Duquin, an upper extremity reconstruction surgeon at UBMD Orthopaedics & Sports Medicine, and BioPrax co-inventor Dr. Anthony Campagnari, SUNY distinguished professor in the UB departments of Microbiology & Immunology and Medicine, recently received a related $744,000 grant to continue work with military researchers to see if the homegrown Buffalo therapy can also be used for implant-related infection control. It is the latest of several related grants approved by the U.S. Armed Services.
“My first major grant was through the DoD for developing ideas to facilitate osseointegrated prosthetic limb use within the military, but they needed to address the possibilities of infection,” Ehrensberger said. “Rickard was very interested in what we were doing with the electrical stim, and for a long time we have been looking for ways that we might be able to work together.”
Garwood Medical signed a memorandum of understanding last June with Integrum AB to explore a collaboration aimed at expanding treatment indications for the OPRA Implant System.
“We need to come up with better tools," Branemark said, "to deal with infections.”
Glenn Runyon’s left leg was amputated in 2015 following a diagnosis of malignant sarcoma behind his knee. While doing research before his amputation surgery, Runyon heard about another prosthetic option. Osseointegration is the name for a surgical approach that connects a prosthesis directly to the bone in the amputated limb. He is one of the first 100 people in the United States to have osseointegration surgery and works with Independence Prosthetics & Orthotics and the University of Delaware PT Clinic to adjust to life with his new limb. Learn more about the UD PT Clinic: https://sites.udel.edu/ptclinic Learn more about Independence: https://www.independencepo.com
“There's a risk of infection with pretty much anything,” said Anders, of ECMC, “but that risk is slightly more involved anytime there is an interface between the outside world and an implant. This is part of the reason why it's taken a long time for this (OPRA technology) to develop.”
Growing research using BioPrax will explore infection control, Ehrensberger said, and whether electrical stimulation can enhance bone growth and soft tissue healing along an implant.
“Those preclinical studies are going to be physically done here in Buffalo,” he said.
Connections between Garwood, Branemark, UB and ECMC have solidified during the last 18 months as the research intensifies.
BioPrax researchers focus on the near future, but also think longer term.
Branemark and the ECMC team want to explore whether the novel, electrical approach to infection control might one day help treat older, sicker people who need amputations.
UB and Garwood researchers hope that proving infection-control along the knee will give rise to similar treatments at the hip, shoulder and spine, as well as other parts of the body where infections develop along metallic surgical implants.
“It's all kind of the same technology, just used in a different manner,” Ehrensberger said. “It just keeps building. It's quite exciting to think that from the first grant to Garwood commercializing the technology, there is potential that this could really impact clinical care and change the lives of patients.
“I certainly know that the only reason it’s been successful is because of so many people's contributions, and the interdisciplinary approach. It's great for people of Western New York to know these kinds of things are happening here.”
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Three Erie County Medical Center surgeons worked with Swedish medical device company Integrum AB to install a technologically advanced implant into two patients from Western New York who have had a leg amputated above the knee, improving their mobility and lowering their risk for infection. They are, from left, Drs. Mark Burke, Thom Loree and Mark Anders.
Dr. Rickard Branemark, an orthopedic surgeon who invented a novel implant for those with leg amputations above the knee, was in Buffalo in September and earlier this month to show a reconstructive surgery team at Erie County Medical Center how to install the OPRA Implant System.
Dr. Thom Loree, chief of the ECMC Department of Head and Neck Surgery and Plastic and Reconstructive Surgery, learned about the OPRA Implant System through a Tonawanda prosthetics company and worked to connect its inventor, Dr. Rickard Branemark, with Garwood Medical Devices and University at Buffalo researchers working on related implant technology.
The OPRA Implant System works similarly to a dental implant. One end of the device is screwed into the center of the femur and the other end protrudes through the amputation site, where it can be attached to a prosthetic leg, affording better mobility.
The OPRA Implant System replaces traditional socket leg prosthetics by better anchoring an implanted medical device above the knee and an attachment outside the amputation site, providing greater mobility.
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