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Steven Gitelis, M.D., has witnessed technological advancements save the lives and limbs of untold orthopedic cancer patients during his 45 years as a surgeon. He became interested in the specialty as a resident at RUSH University, completed fellowships under world-renowned surgeons and returned to his alma mater to start its first orthopedic oncology program more than four decades ago.
Sarcoma, a type of cancer that forms tumors in the body’s connective tissues like bones and muscles, is rare and typically not seen by the average surgeon. RUSH sees up to 300 tumors a year. As Director of Musculoskeletal Oncology, Dr. Gitelis has extensive experience in treating patients who often face excruciating conditions.
“The field is challenging and academic, and you have to exercise creativity because every operation is customized to the patient,” he said. “I operate on babies to the elderly, from the toes to the nose. It is highly varied, which I find attractive.”
When Dr. Gitelis was a young surgeon, orthopedic oncology outcomes were measured by the patient’s survival. At the time, about 80% of patients succumbed to cancer. While localized sarcoma has a 5-year survival rate of 80% today, he said, significant obstacles persist for this group.
Limb salvage, for example, remains an issue but has seen recent success due to durable, customizable implants. Dr. Gitelis is a big proponent of 3D-printed cutting guides and implants that provide surgical accuracy and bone-ingrowth capabilities.
He said the latest focus in the field is the unsolved clinical problem of infection prevention. Mitigating infections could significantly increase the success of limb salvage procedures.
“Chemotherapy patients do not have good immunity,” Dr. Gitelis said. “Limb salvage operations take a long time and involve one- to two-foot-long incisions to implant large pieces of metal that restore the limb. The risk for infection is as high as 20%, which is much higher than other orthopedic procedures. Infection is an absolute disaster in these cases. It costs healthcare systems thousands of dollars and often the patient their limb.”
Dr. Gitelis also serves as Chief Medical Officer at Onkos Surgical, a company dedicated to serving orthopedic patients with cancer and other complex conditions. He recently performed the first surgery with Onkos Surgical’s NanoCept Antibacterial Technology, a novel coating applied to implants to help address intraoperative bacterial contamination.
Onkos cited papers showing that an estimated 60% to 70% of all early and delayed onset periprosthetic joint infections (PJIs) are initiated at the time of the procedure through intraoperative contamination. PJIs are expected to cost the U.S. healthcare system up to $1.8 billion by 2030. Further, the five-year mortality rate of PJI is higher than that of skin cancer, testicular cancer, breast cancer, melanoma, Hodgkin’s lymphoma and, in some studies, colon cancer.
Despite the numerous measures taken to keep an operating room sterile, Dr. Gitelis said there is an unequivocal need for an implant that can stave off bacteria between when it is unpackaged and implanted in a patient.
Onkos received FDA De Novo market authorization for NanoCept on its ELEOS Limb Salvage System, a modular total joint system used for patients with bone loss. The company is actively working to expand NanoCept’s regulatory clearances for implants used in joint reconstruction surgeries due to tumor, trauma and other orthopedic revision procedures.
“Infection is every surgeon’s nightmare, and this technology can help address that,” Dr. Gitelis said. “It’s really exciting for orthopedic oncology and complex joint reconstruction surgeons.”
NanoCept is a quaternary ammonium compound covalently bonded to the implant’s surface. The coating bursts the bacteria’s membrane when the two connect. Standardized in vitro testing showed that the coating is 99.999% (5-log reduction) effective in killing bacteria commonly found in the operating room.
Antibacterial technology is often associated with eluting compounds that spread throughout the joint to eliminate bacteria, Dr. Gitelis said. NanoCept’s non-eluting technology makes it unique and was instrumental in getting FDA authorization.
“FDA does not support of the use of antibiotics to protect devices because of resistant strains,” he said. “While the coating is a chemical, it’s not an antibiotic.”
Dr. Gitelis, who does not receive royalties from Onkos, was involved in NanoCept’s development, quality and regulatory processes. He said the company worked with FDA for over six years to earn the De Novo and completed more than 60 individual tests, studies and assays for the submission.
“The NanoCept Technology represents a significant advancement in the preventative measures my colleagues and I use to mitigate the potentially devastating complications related to intraoperative bacterial contamination of implants,” he said. “It has the potential to create a paradigm shift in implant selection and is a valuable tool surgeons will now have that may help address an unsolved clinical problem.”
Steven Gitelis, M.D., has witnessed technological advancements save the lives and limbs of untold orthopedic cancer patients during his 45 years as a surgeon. He became interested in the specialty as a resident at RUSH University, completed fellowships under world-renowned surgeons and returned to his alma mater to start its first orthopedic...
Steven Gitelis, M.D., has witnessed technological advancements save the lives and limbs of untold orthopedic cancer patients during his 45 years as a surgeon. He became interested in the specialty as a resident at RUSH University, completed fellowships under world-renowned surgeons and returned to his alma mater to start its first orthopedic oncology program more than four decades ago.
Sarcoma, a type of cancer that forms tumors in the body’s connective tissues like bones and muscles, is rare and typically not seen by the average surgeon. RUSH sees up to 300 tumors a year. As Director of Musculoskeletal Oncology, Dr. Gitelis has extensive experience in treating patients who often face excruciating conditions.
“The field is challenging and academic, and you have to exercise creativity because every operation is customized to the patient,” he said. “I operate on babies to the elderly, from the toes to the nose. It is highly varied, which I find attractive.”
When Dr. Gitelis was a young surgeon, orthopedic oncology outcomes were measured by the patient’s survival. At the time, about 80% of patients succumbed to cancer. While localized sarcoma has a 5-year survival rate of 80% today, he said, significant obstacles persist for this group.
Limb salvage, for example, remains an issue but has seen recent success due to durable, customizable implants. Dr. Gitelis is a big proponent of 3D-printed cutting guides and implants that provide surgical accuracy and bone-ingrowth capabilities.
He said the latest focus in the field is the unsolved clinical problem of infection prevention. Mitigating infections could significantly increase the success of limb salvage procedures.
“Chemotherapy patients do not have good immunity,” Dr. Gitelis said. “Limb salvage operations take a long time and involve one- to two-foot-long incisions to implant large pieces of metal that restore the limb. The risk for infection is as high as 20%, which is much higher than other orthopedic procedures. Infection is an absolute disaster in these cases. It costs healthcare systems thousands of dollars and often the patient their limb.”
Dr. Gitelis also serves as Chief Medical Officer at Onkos Surgical, a company dedicated to serving orthopedic patients with cancer and other complex conditions. He recently performed the first surgery with Onkos Surgical’s NanoCept Antibacterial Technology, a novel coating applied to implants to help address intraoperative bacterial contamination.
Onkos cited papers showing that an estimated 60% to 70% of all early and delayed onset periprosthetic joint infections (PJIs) are initiated at the time of the procedure through intraoperative contamination. PJIs are expected to cost the U.S. healthcare system up to $1.8 billion by 2030. Further, the five-year mortality rate of PJI is higher than that of skin cancer, testicular cancer, breast cancer, melanoma, Hodgkin’s lymphoma and, in some studies, colon cancer.
Despite the numerous measures taken to keep an operating room sterile, Dr. Gitelis said there is an unequivocal need for an implant that can stave off bacteria between when it is unpackaged and implanted in a patient.
Onkos received FDA De Novo market authorization for NanoCept on its ELEOS Limb Salvage System, a modular total joint system used for patients with bone loss. The company is actively working to expand NanoCept’s regulatory clearances for implants used in joint reconstruction surgeries due to tumor, trauma and other orthopedic revision procedures.
“Infection is every surgeon’s nightmare, and this technology can help address that,” Dr. Gitelis said. “It’s really exciting for orthopedic oncology and complex joint reconstruction surgeons.”
NanoCept is a quaternary ammonium compound covalently bonded to the implant’s surface. The coating bursts the bacteria’s membrane when the two connect. Standardized in vitro testing showed that the coating is 99.999% (5-log reduction) effective in killing bacteria commonly found in the operating room.
Antibacterial technology is often associated with eluting compounds that spread throughout the joint to eliminate bacteria, Dr. Gitelis said. NanoCept’s non-eluting technology makes it unique and was instrumental in getting FDA authorization.
“FDA does not support of the use of antibiotics to protect devices because of resistant strains,” he said. “While the coating is a chemical, it’s not an antibiotic.”
Dr. Gitelis, who does not receive royalties from Onkos, was involved in NanoCept’s development, quality and regulatory processes. He said the company worked with FDA for over six years to earn the De Novo and completed more than 60 individual tests, studies and assays for the submission.
“The NanoCept Technology represents a significant advancement in the preventative measures my colleagues and I use to mitigate the potentially devastating complications related to intraoperative bacterial contamination of implants,” he said. “It has the potential to create a paradigm shift in implant selection and is a valuable tool surgeons will now have that may help address an unsolved clinical problem.”
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Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She joined ORTHOWORLD in 2012 to oversee its editorial and industry education. She previously served in editor roles at B2B magazines and newspapers.
