DePuy Synthes Addresses Clinical Demand to Reduce the Incidence of Implant Related Infections with Expert Tibial Nail PROtect

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^1–3.

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)⁶. 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 intervention⁴.

“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 ⁵ .”

“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%⁶. 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 coating⁷. The design of Expert Tibial Nail itself has been shown to reduce operating time, hospital stay, full weight bearing time and union time⁸.

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^9–12. Studies have reported no deep infections^9–12, 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 infection¹⁵. 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.

- Ends –

About DePuy Synthes Companies

DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

* Prof. Dr. med Michael Raschke and Prof. Dr. med. Gerhard Schmidmaier are paid consultants to DePuy Synthes and design surgeons of the Expert Tibial Nail PROtect.

DePuy Synthes, part of the Johnson & Johnson Family of Companies

All rights reserved.

___________________________

References

1. Infection. AO Foundation, 2012. (Accessed 24 July 2016) https://www2.aofoundation.org/wps/portal/surgery?showPage=redfix&bone=Tibia&segment=Shaft&classification=42-Special%20considerations&treatment=&method=Special%20considerations&implantstype=Complications&approach=&redfix_url=1341319024234

2. Hannigan GD, Pulos N, Grice EA, Mehta S. Current Concepts and Ongoing Research in the Prevention and Treatment of Open Fracture Infections. Advances in wound care 2015;4:59-74.

3. Mouzopoulos G, Kanakaris NK, Kontakis G, Obakponovwe O, Townsend R, Giannoudis PV. Management of bone infections in adults: the surgeon's and microbiologist's perspectives. Injury 2011;42 Suppl 5:S18-23.

4. McHugh SM, Collins CJ, Corrigan MA, Hill AD, Humphreys H. The role of topical antibiotics used as prophylaxis in surgical site infection prevention. The Journal of Antimicrobial Chemotherapy 2011;66:693-701.

5. Romano CL, Scarponi S, Gallazzi E, Romano D, Drago L. Antibacterial coating of implants in orthopaedics and trauma: a classification proposal in an evolving panorama. Journal of Orthopaedic Surgery and Research 2015;10:157.

6. Craig J, Fuchs T, Jenks M, et al. Systematic review and meta-analysis of the additional benefit of local prophylactic antibiotic therapy for infection rates in open tibia fractures treated with intramedullary nailing. International orthopaedics 2014;38:1025-30.

7. Attal R, Hansen M, Kirjavainen M, Bail H, Hammer TO, Rosenberger R, Höntzsch D, Rommens PM (2012) A multicentre case series of tibia fractures treated with the Expert Tibia Nail (ETN). Arch Orthop Trauma Surg 132(7):975-84.

8. Li Y, Liu L, Tang X, Pei F, Wang G, Fang Y, Zhang H, Crook N (2012) Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metaphyseal fractures. Int Orthop 36(7):1457-62.

9. Raschke MJ, Rosslenbroich, S.B., Fuchs, T.F. Gentamicin-coated Tibia Nails: Can We Afford NOT to Use Them? Techniques in Orthopaedics 2014;29:62-8.

10. Fuchs T, Stange R, Schmidmaier G, Raschke MJ. The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study. Archives of orthopaedic and trauma surgery 2011;131:1419-25.

11. Raschke M, Vordemvenne T, Fuchs T. Limb salvage or amputation? The use of a gentamicin coated nail in a severe, grade IIIc tibia fracture. European journal of trauma and emergency surgery : official publication of the European Trauma Society 2010;36:605-8.

12. Metsemakers WJ, Reul M, Nijs S. The use of gentamicin-coated nails in complex open tibia fracture and revision cases: A retrospective analysis of a single centre case series and review of the literature. Injury 2015;46:2433-7.

13. DePuy Synthes Trauma adoSG. Resource Utilization and Costs of Patients with Tibia Fractures and Related Infections. Data on File. 2016.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161031005861/en/

Contact information

DePuy Synthes
Jennifer Holden
Sr. Manager, Communications
jholden2@its.jnj.com