המסמר התוך לשדי היחיד עם ציפוי אנטיביוטי נספג מחדש שנמצא
בשוק כיום פותח כדי לספק הגנה ממוקדת מפני התיישבות של חיידקים
DePuy
Synthes, חלק ממשפחת
החברות של Johnson & Johnson,הודיעה היום על הזמינות של Expert Tibial Nail PROtect,
המסמר לעצם השוק היחיד עם ציפוי אנטיביוטי נספג מחדש שמיועד לספק הגנה נוספת מפני
התיישבות של חיידקים לחולים שבסיכון גבוה לזיהום. זיהום בעקבות קיבוע שברים מוכר
כבעיה קלינית שחשיבותה הולכת וגדלה, ותוצאותיה יכולות להיות טיפול ממושך, החלמה
לקויה של השבר ובמקרים מסוימים, לדוגמה אנשים עם סוכרת, קטיעה של האיבר1–3.
DePuy Synthes
Addresses Clinical Demand to Reduce the Incidence of Implant Related Infections
with Expert Tibial Nail PROtect
The
only intramedullary nail with a resorbable antibiotic coating on the market
today.
Developed
to deliver targeted protection against bacterial colonization.
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 amputation1–3.
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 infection5.”
“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 nails9–12. Studies have
reported no deep infections9–12, 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
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.
