0x6.001.264_AB 04.06.12 10:55 Seite Cvr1
Expert Tibial Nail PROtect. Why risk an
infection?
Prevents bacterial
colonization on
implant surface
Enhances safety in
higher risk patients
Antibiotic coating
with no systemic
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 to a fracture fixation device.
Orthopedic surgeons have been using antibiotic-laden
PMMA cement for the fixation of hip prostheses for more
than 30 years, which has been proven to achieve a significantly higher success rate.1 By implementing the local application of antibiotics to implants, the Synthes Expert Tibial
Nail PROtect enhances safety in cases with increased risk of
bony infection by preventing bacterial colonization on
the implant.
The PROtect antibiotic coating is:
– completely resorbable
– tested in-vitro and in-vivo for safety and effectiveness
The Expert Tibial Nail PROtect:
– uses the same technique and instrumentation as the
Synthes Expert Tibial Nail (uncoated)
For detailed instructions on using the Expert Tibial Nail,
consult the technique guide 036.000.380.
Expert Tibial Nail PROtect
Expert Tibial Nail PROtect
Synthes
1
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 a serious threat to all
patients treated for tibial injuries. Due to the low level of
vascular perfusion in the tibia, infections are difficult to treat
with systemic antibiotics. Further, the impact of trauma
compromises the immune system where it is most needed,
therefore increasing the risk of infection.3
Upon implantation, the host’s immune system recognizes an
implant as a foreign body and a “race for the surface”
begins, where bacteria and host immune cells compete to
colonize the surface.6 While the bacterial colonization of
an implant surface does not necessarily lead to an infection,
it is the first step in a series of events that can ultimately
lead to an infection.
Implant related infections
Bacteria show sophisticated defense mechanisms against the
immune system and the influence of systemic antibiosis.
The presence of a foreign surface such as an implant, gives
bacteria the possibility to form a protective biofilm.
� Bacteria
� Implant
� Biofilm
� Antibiotic molecules
� Macrophage
Bacteria adhering to the implant surface require up to 800
times higher antibiotic concentrations, which cannot be
provided by systemic application.5
�
�
쏹
Bacteria colonize on the implant surface
2
Synthes
Expert Tibial Nail PROtect
�
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
�
�
쏹
�
쏹
�
쏹
Bacteria form a protective biofilm
�
쏹
Biofilm protects bacteria from antibiotic action and immune response
Expert Tibial Nail PROtect
Synthes
3
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. It releases high doses of
antibiotics where systemic admission
cannot reach (local concentration is up
to 1000 times higher than in systemic
application).5 It is highly local with no
detectable systemic side effects.
�
쏹
�
쏹
�
쏹
� PROtect antibiotic coating
� Coated medical device
� Bacteria
� Dead bacteria
*Resorption time may vary depending on patient specific conditions.
4
Synthes
Expert Tibial Nail PROtect
�
쏹
�
쏹
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 important support tool
in infection prevention.
*Compared to other methods
6
Synthes
Expert Tibial Nail PROtect
Weeks
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 a low allergenic
potential and shows a synergistic effect in combination with
Cephalosporins.11
Intended use*
The Expert Tibial Nail PROtect covers the same indications as
the Synthes Expert Tibial Nail (uncoated).** The use of an
implant with PROtect coating must be individually assessed
in each case. PROtect is especially well suited for all cases
with an increased risk of infection. These include:
– All open fractures (Gustilo-Anderson Grade I to III)
– Secondary nailing (nail to nail and external fixator to nail),
especially revisions due to infections
– Polytrauma
– Immunodeficiencies such as diabetes mellitus, obesity,
alcohol abuse, smoking, etc.
Contraindications
– Established or suspected intolerance/allergy to gentamicin
or other aminoglycosides
– Established or suspected intolerance/allergy to polylactides
*Please see instruction for use for complete indications, contraindications,
precautions and warnings.
**The Expert Tibial Nail is indicated for fractures of the tibial shaft as well as for
metaphyseal and certain intraarticular fractures of the tibial head and the pilon
tibiale:
− 41-A2/A3
− All shaft fractures
− 43-A1/A2/A3
− Combination of these fractures
For these indications the Expert Tibial Nail should be used in combination with
other implants:
− 41-C1/C2
− 43-C1/C2
Expert Tibial Nail PROtect
Synthes
7
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). This was followed by the application of
an external fixator, irrigation of the perforation site and
temporary coverage of the soft tissue. After ten days, the
external fixator was exchanged for an Expert Tibial Nail
PROtect (⭋ 10 mm, length 390 mm) during a single-stage
surgery.
Postoperative
8
Synthes
Expert Tibial Nail PROtect
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. The patient returned to work on a
part-time basis.
Follow-up (6 months after surgery)
Six months postoperatively, the patient was pain free, with
inconspicuous soft tissue scarring and free mobility of the
adjacent joints. The patient resumed full-time work.
Clinical result*
Length, axis and rotation were fully reconstructed, and the
nail statically locked. The soft tissue regeneration and the
bony consolidation led to complication-free fracture healing.
Follow-up (3 months after surgery)
Surgeon comments
“Open fractures and fractures with severe soft tissue damage
pose an increased risk of infection. In such cases, the
antibiotic-laden PROtect coating protects the implant against
bacterial colonization and enhances safety for higher risk
patients. The additional safety provided by the Expert Tibial
Nail PROtect allowed the single-stage exchange surgery from
external to internal fixation.“
* Results from case reports are not necessarily predictive of results in other cases.
Results in other cases may vary.
This case example was provided with kind permission from Prof. Dr. Michael J.
Raschke, Clinical Director for Trauma, Hand and Reconstructive Surgery,
University Hospital Münster, Germany.
Expert Tibial Nail PROtect
Synthes
9
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 Tibial Nail PROtect
0x6.001.264_AB 04.06.12 10:55 Seite 11
Implants
Expert Tibial Nails with PROtect antibiotic coating,
cannulated
Only available in sterile packaging
Length ⭋ 8 mm
(mm) dark blue
⭋ 9 mm
dark blue
⭋ 10 mm
light green
255
04.004.231SAB
04.004.331SAB
04.004.431SAB
270
04.004.234SAB
04.004.334SAB
04.004.434SAB
285
04.004.237SAB
04.004.337SAB
04.004.437SAB
300
04.004.240SAB
04.004.340SAB
04.004.440SAB
315
04.004.243SAB
04.004.343SAB
04.004.443SAB
330
04.004.246SAB
04.004.346SAB
04.004.446SAB
345
04.004.249SAB
04.004.349SAB
04.004.449SAB
360
04.004.252SAB
04.004.352SAB
04.004.452SAB
375
04.004.255SAB
04.004.355SAB
04.004.455SAB
390
04.004.258SAB
04.004.358SAB
04.004.458SAB
405
04.004.261SAB
04.004.361SAB
04.004.461SAB
420
04.004.264SAB
04.004.364SAB
04.004.464SAB
435
04.004.267SAB
04.004.367SAB
04.004.467SAB
450
04.004.270SAB
04.004.370SAB
04.004.470SAB
465
04.004.273SAB
04.004.373SAB
04.004.473SAB
Length ⭋ 11 mm
(mm) light green
⭋ 12 mm
light green
⭋ 13 mm
light green
255
04.004.531SAB
04.004.631SAB
04.004.731SAB
270
04.004.534SAB
04.004.634SAB
04.004.734SAB
285
04.004.537SAB
04.004.637SAB
04.004.737SAB
300
04.004.540SAB
04.004.640SAB
04.004.740SAB
315
04.004.543SAB
04.004.643SAB
04.004.743SAB
330
04.004.546SAB
04.004.646SAB
04.004.746SAB
345
04.004.549SAB
04.004.649SAB
04.004.749SAB
360
04.004.552SAB
04.004.652SAB
04.004.752SAB
375
04.004.555SAB
04.004.655SAB
04.004.755SAB
390
04.004.558SAB
04.004.658SAB
04.004.758SAB
405
04.004.561SAB
04.004.661SAB
04.004.761SAB
420
04.004.564SAB
04.004.664SAB
04.004.764SAB
435
04.004.567SAB
04.004.667SAB
04.004.767SAB
450
04.004.570SAB
04.004.670SAB
04.004.770SAB
465
04.004.573SAB
04.004.673SAB
04.004.773SAB
⭋ 8 mm
⭋ 10 mm
⭋ 11 mm
⭋ 12 mm
⭋ 9 mm
⭋ 13 mm
Expert Tibial Nail PROtect
Synthes
11
0x6.001.264_AB 04.06.12 10:55 Seite 12
Bibliography
1
2
3
4
5
6
7
8
9
10
11
12
12
Espehaug, B, LB Engesaeter, SE Vollset, LI Havelin, N Langeland. “Antibiotic Prophylaxis in Total Hip Arthroplasty:
Review of 10 905 Primary Cemented Total Hip Replacements Reported to the Norwegian Arthroplasty Register,
1987 TO 1995.” J Bone Joint Surg 79 (4) (1997): 590-595.
Fluckiger, U, W Zimmerli. “Factors influencing
antimicrobial therapy of surface adhering microorganisms.”
Recent Res. Devel. Antimicrob Agents Chemother 4
(2000): 165–175.
Vaudaux, P, DP Lew. “Tolerance of staphylococci to
bactericidal antibiotics.” Injury 37 (2006): 15–19.
Gristina, AG, PT Naylor, QN Myrvik. “Musculoskeletal Infection, Microbial Adhesion, and Antibiotic Resistance.”
Infect Dis Clin North Am 4 (3) (1990): 391-408.
Diefenbeck, M, T Mückley, GO Hofmann. “Prophylaxis
and treatment of implant-related infections by local application of antibiotics.” Injury 37 (2006): 95–104.
Harris, LG, RG Richards. “Staphylococci and implant
surfaces: a review.” Injury 37 (2006): 3–14. application of
antibiotics.” Injury 37 (2006): 95–104.
Darouiche, RO. “Treatment of infections associated with
surgical implants.” N Engl J Med 350 (14) (2004):
1422–1429.
Richards, RG, LG Harris, E Schneider, N Haas. “Antiseptics
and antibiotics on implants.” Injury 37 (2006): 113–116.
Stemberger, A, H Grimm, F Bader, HD Rahn, R Ascherl.
“Local Treatment of Bone and Soft Tissue Infections with
the Collagen-gentamicin Sponge.” Eur J Surg Suppl 578
(1997): 17–26.
Schmidmaier, G, M Lucke, B Wildemann, NP Haas.
“Prophylaxis and treatment of implant-related infections
by antibiotic-coated implants: a review.” Injury 37 (2006):
105–112.
Gilbert, D. “Aminoglycosides.” In: Mandell, Douglas, and
Bennett's Principles and practice of infectious diseases. edited by G Mandell, J Bennett, R Dohlin, 279-306. Churchill
Livingstone, 2000.
Lucke, M, G Schmidmaier, S Sadoni, B Wildemann,
R Schiller, NP Haas, M Raschke. “Gentamicin coating of
metallic implants reduces implant-related osteomyelitis in
rats.” Bone 32 (2006): 521–531.
Synthes
Expert Tibial Nail PROtect
0x6.001.264_AB 04.06.12 10:55 Seite Cvr3
All technique guides are available as PDF files at
www.synthes.com/lit
0123
version AB
Ö036.001.264öAB?ä
036.001.264
06/2012
30101328
© Synthes, Inc. or its affiliates
Subject to modifications
Synthes is a trademark of Synthes, Inc. or its affiliates
0x6.001.264_AB 04.06.12 10:55 Seite Cvr4