October 31, 2016
DePuy Synthes, part of the Johnson & Johnson Family of Companies, today announced the availability of Expert Tibial Nail PROtect, the only tibial nail with a resorbable antibiotic coating designed to provide additional protection from bacterial colonization for patients who are at high risk of infection. Infection following fracture fixation is recognised as an increasingly important clinical problem, and can result in prolonged treatment, impaired fracture healing and in some cases, for example people with diabetes, may result in limb amputation.
Designed in collaboration with leading AO surgeons, Expert Tibial Nail PROtect addresses a growing clinical demand to reduce the incidence of implant related infections. Infection can occur in up to 14.4% of all open tibia fractures treated with intramedullary nailing (without an antibacterial coating). Open tibial shaft fractures are often associated with a high incidence of complications, due to the precarious blood supply to the tibia, the high risk of infection and the necessity of rapid surgical intervention.
“Infection following fracture fixation is one of the most severe problems we face in daily practice, with potentially devastating consequences for the patient,” said Prof. Dr. med Michael Raschke, Clinical Director, University of Muenster, Germany. “A biofilm can form on an implant within 12–18 hours post-surgery which may trigger an infection.”
“Expert Tibial Nail PROtect provides me with an additional tool to help reduce infection rates and benefit my patients’ outcomes,” concluded Prof. Dr. med. Gerhard Schmidmaier, Head of Trauma Department, Heidelberg University Hospital, Germany.
Adding locally administered antibiotics to general prophylactic antibiotics has been shown to reduce the infection rate for patients with severe fractures from 14.4% to 2.4%. Expert Tibial Nail PROtect offers a treatment option developed to deliver targeted protection and prevent a bacterial biofilm forming on the implant thus decreasing the risk of infection.
“By adding the PROtect coating to the existing Expert Tibial Nail, we are providing surgeons with the technology to address their highest risk trauma patients,” said Elmar Zurbriggen, DePuy Synthes Franchise Lead for Europe, Middle East and Africa. “By preventing bacterial colonization on the implant surface, we hope that patients will experience an improved recovery process while reducing the need for additional treatment costs for healthcare providers.”
The Expert Tibial Nail’s use in tibia fracture repair, demonstrates improved patient outcomes, which is why it was selected for application of the PROtect antibiotic coating. The design of Expert Tibial Nail itself has been shown to reduce operating time, hospital stay, full weight bearing time and union time.
Clinical experience has provided evidence to support the benefits of using Expert Tibial Nail PROtect. It demonstrates the performance and safety of the PROtect coating with intramedullary nails. Studies have reported no deep infections, and treatment costs for patients with an infection following a tibia fracture were shown to be up to 3.5 times higher compared to those for patients with no infection. These are attributed to the additional surgery required to manage the infection (e.g. implant removal, bone grafting, amputation) and the prolonged hospital stay as well as readmissions and treatment in the intensive care unit for patients with an infection.