NYU Langone Health has completed its first surgery using the only U.S. Food and Drug Administration (FDA)–approved implantable prosthetic for amputees available in the greater New York City area. The procedure, known as osseointegration, seeks to improve quality of life for people with limb loss by enhancing the connection between limb and prosthesis.
The two-step surgical procedure was performed by physicians at NYU Langone's Center for Amputation Reconstruction in partnership with Integrum, which developed the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System. The OPRA Implant System is the first and only FDA-approved technology for bone-anchored prostheses in the United States.
"The opportunity to provide this unique and comprehensive solution for our patients indicates a paradigm shift in the treatments we are able to offer individuals with limb loss and help improve their day-to-day lives," said Omri B. Ayalon, MD, an orthopedic surgeon and co-director of the Center for Amputation Reconstruction. "Osseointegration is a life-changing procedure, and we collaborate with our multidisciplinary team to tailor the treatment plan to each individual's needs and expectations."
Led by Dr. Ayalon and Jacques H. Hacquebord, MD, the Center for Amputation Reconstruction now adds osseointegration treatment to its other advanced surgical techniques and prosthetic technologies for individuals experiencing limb loss. Its experienced team includes highly skilled surgeons, on-site occupational therapists, prosthetists, and mental health professionals who collaborate on the care offered to every patient. Nicola Fabbri, MD, chief of the Division of Orthopedic Oncology, part of NYU Grossman School of Medicine's Orthopedics and NYU Langone's Perlmutter Cancer Center, will also incorporate the program into treatment options for patients with bone cancer as part of the spectrum of strategies aimed at maximizing function, including complex limb preservation and limb restoration by osseointegration.
Osseointegration is a surgical procedure to permanently implant a titanium device into the bone for direct attachment to an artificial limb. This revolutionary approach is a viable alternative to standard socket prostheses, and offers a range of benefits for amputee patients, including improved mobility, enhanced comfort, and reduced pressure. Osseointegration eliminates problems related to skin irritation or limited ambulation with the prothesis. People with osseointegrated implants enjoy greater perception of surfaces, reduced residual limb pain, greater stability, and increased usage of their prosthetic limbs.
The OPRA Implant System is installed via two surgical procedures. In the first surgery, doctors implant the fixture into the bone, after which sufficient followed by healing time is allowed for the bone to fully grow onto the fixture and anchor it. In the second surgery, doctors attach an abutment to the fixture and extend it through the skin to connect it to the external prosthesis. More traditional rehabilitation is then conducted, including fitting with a customized final prosthesis.
The Center for Amputation Reconstruction team successfully completed the initial surgical procedure, performed by Dr. Ayalon and Dr. Hacquebord, of its first patient in August 2022. The second surgery was performed in November 2022.
In December 2020, the FDA approved OPRA for people who have transfemoral, or above-knee, amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.