Expert Tibial Nail PROtect. Why risk an Prevents bacterial implant surface higher risk patients Antibiotic coating side effects

0x6.001.264_AB 04.06.12 10:55 Seite Cvr2 Expert Tibial Nail PROtect Antibiotic Coating

0x6.001.264_AB 04.06.12 10:55 Seite 1 Expert Tibial Nail PROtect. Why risk an infection? Infections remain a feared complication in fracture care. The PROtect antibiotic coating builds on the proven advantages of fracture treatment with the Expert Tibial Nail by additionally offering effective protection from bacterial colonization through local antibiotic prophylaxis. A thin film of poly(D,L-lactic acid) (PDLLA) containing the antibiotic gentamicin sulfate covers the surface of the nail, including the cannulation. With the Expert Tibial Nail PROtect, Synthes applies established methods in orthopedics...

0x6.001.264_AB 04.06.12 10:55 Seite 2 Infection: General Aspects Bony infections Bony infections are complex events, which are influenced by a multitude of factors. In general, bony infections are promoted by incorporated implants. The presence of an implant increases the risk of infection by a factor of 10'000.2,3 Local wound contamination, blood-borne pathogens, the general immune strength of the patient as well as co-morbidities and the use of immuno-suppresive drugs are among the factors which can contribute to the occurrence of an implant related infection. Bony infections of the tibia pose...

0x6.001.264_AB 04.06.12 10:55 Seite 3 Consequences of bony infections The consequences of bony infections can be dire and may lead to prolonged hospitalization, revision procedures, amputation or even death.4 Further, poor patient outcomes can potentially lead to law suits and damage the reputation of the hospital and surgeon. The average costs of combined medical and surgical treatment for bony infections are as high as $25'000 per case.7 ᕤ ᕥ © ᕣ © ᕢ © Bacteria form a protective biofilm ᕢ © Biofilm protects bacteria from antibiotic action and immune response Expert Tibial Nail PROtect Synthes...

0x6.001.264_AB 04.06.12 10:55 Seite 4 Synthes Solutions The Expert Tibial Nail PROtect, including its cannulation, is coated with a thin layer (approximately 50 μm) of antibiotic-laden polymer. The coating is abrasion resistant and will withstand most of the forces occurring during nail insertion. The coating releases the antibiotic immediately after implantation for the duration of approximately 2 weeks. It is completely resorbed after approximately 6 months.* PROtect – protection from bacterial colonization PROtect impedes bacteria from adhering to the implant surface and producing biofilms....

0x6.001.264_AB 04.06.12 10:55 Seite 5 Features and Benefits Antibiotic coating with no systemic side effects Very low levels of antibiotic in the blood serum. Enhances safety in higher risk patients Antibiotic prophylaxis from within the bone. Prevents bacterial colonization on the implant surface Antibiotic coating releases antibiotic into the area surrounding the implant. Shown to be effective in cases with more resistant organisms9 Antibiotic agent shows a concentration-dependent bactericidal activity. Expert Tibial Nail PROtect Synthes 5

0x6.001.264_AB 04.06.12 10:55 Seite 6 Safety and Effectiveness Antibiotic release The coating is completely resorbable. The antibiotic is released within the first hours and days after implantation, as schematically shown below: Release of gentamicin 100 Released Gentamicin Sulfate (%) 80 60 40 20 0 Implantation Days The initial release creates high concentrations of the antibiotic agent. It is released at the right time, in sufficient amounts and in a way that reduces the risk of antibiotic resistance.*8,9 It is released with no risk of systemic toxicity.10 PROtect coating can therefore be an...

0x6.001.264_AB 04.06.12 10:55 Seite 7 PROtect coating – building on proven values PROtect coating contains the antibiotic agent gentamicin. Gentamicin has a proven record of success as the most commonly used antibiotic for local application in combination with bone cement for prosthetics.5 It has a concentration-dependent bactericidal activity8 and does not cause one-step mutations;11 this reduces the risk of bacterial resistances. It is effective against the bacteria most commonly responsible for deep wound infection: Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas. It has...

0x6.001.264_AB 04.06.12 10:55 Seite 8 Clinical experience Patient history A 26-year-old male presented with polytrauma and perforated chest trauma, dissection of the subclavian artery with thrombus, a crush injury of the lower right leg and a third degree open fracture of the right tibial shaft with suspected vessel injury. There was a high risk of infection due to very distressed soft tissue in the fracture zone. An Expert Tibial Nail PROtect was therefore used for the medullary nailing. Preoperative (CT-scan) Surgical treatment The patient underwent a thoracotomy and a partial pneumectomy (left)....

0x6.001.264_AB 04.06.12 10:55 Seite 9 Postoperative treatment Six weeks postoperatively, partial load bearing (20 kg) was possible. Soft tissue at the perforation site closed, and the patient regained free mobility of the knee and ankle joints. The laboratory tests showed low-key results with CRP 1.8 mg/dl and leucocytes 6 700 / μl. The patient commenced increased load bearing and underwent intensive ambulant physiotherapy and lymphatic drainage. Three months postoperatively, full load bearing was possible, the soft tissue completely healed, and the bony consolidation progressed as expected....

0x6.001.264_AB 04.06.12 10:55 Seite 10 Effectiveness In-vivo infection models have shown that the PROtect coating prevents the proliferation of bacteria on the implant and its surrounding area.12 Tibiae of rats were infected with Staphylococcus aureus and nailed with either PROtect coated Kirschner wires or uncoated Kirschner wires. Swabbing of the explanted PROtect coated Kirschner wires 21 and 42 days after implantation showed a dramatic reduction of bacterial growth. Uncoated implant PROtect coated implant Images courtesy of Dr. T. Fuchs, Universitätsklinikum Münster, Germany. 10 Synthes Expert...