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Expert Tibial Nail PROtect. Why risk aninfection?

Prevents bacterialcolonization onimplant surface

Enhances safety inhigher risk patients

Antibiotic coatingwith no systemicside effects

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Expert Tibial Nail PROtect Antibiotic Coating

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Expert Tibial Nail PROtect Synthes 1

Infections remain a feared complication in fracture care. ThePROtect antibiotic coating builds on the proven advantagesof fracture treatment with the Expert Tibial Nail by addition-ally offering effective protection from bacterial colonizationthrough 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 estab-lished methods in orthopedics to a fracture fixation device.Orthopedic surgeons have been using antibiotic-ladenPMMA cement for the fixation of hip prostheses for more

Expert Tibial Nail PROtect. Why risk aninfection?

Expert Tibial Nail PROtect

than 30 years, which has been proven to achieve a signifi-cantly higher success rate.1 By implementing the local appli-cation of antibiotics to implants, the Synthes Expert TibialNail PROtect enhances safety in cases with increased risk ofbony infection by preventing bacterial colonization onthe 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.

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Bony infections are complex events, which are influenced bya multitude of factors. In general, bony infections are pro-moted by incorporated implants. The presence of an implantincreases the risk of infection by a factor of 10'000.2,3 Localwound contamination, blood-borne pathogens, the generalimmune strength of the patient as well as co-morbidities andthe use of immuno-suppresive drugs are among the factorswhich can contribute to the occurrence of an implant relatedinfection.

Upon implantation, the host’s immune system recognizes animplant as a foreign body and a “race for the surface” begins, where bacteria and host immune cells compete tocolonize the surface.6 While the bacterial colonization ofan implant surface does not necessarily lead to an infection,it is the first step in a series of events that can ultimatelylead to an infection.

Infection: General Aspects

Bony infections

2 Synthes Expert Tibial Nail PROtect

Bacteria show sophisticated defense mechanisms against theimmune system and the influence of systemic antibiosis.

The presence of a foreign surface such as an implant, givesbacteria the possibility to form a protective biofilm.

Bacteria adhering to the implant surface require up to 800times higher antibiotic concentrations, which cannot be provided by systemic application.5

Implant related infections

Bacteria colonize on the implant surface

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 treatwith systemic antibiotics. Further, the impact of traumacompromises the immune system where it is most needed,therefore increasing the risk of infection.3

� Bacteria

� Implant

� Biofilm

� Antibiotic molecules

� Macrophage

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The consequences of bony infections can be dire and maylead to prolonged hospitalization, revision procedures, amputation or even death.4

Further, poor patient outcomes can potentially lead to lawsuits and damage the reputation of the hospital and surgeon.

The average costs of combined medical and surgical treat-ment for bony infections are as high as $25'000 per case.7

Consequences of bony infections


Bacteria form a protective biofilm Biofilm protects bacteria from antibiotic action and immune response

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Synthes Solutions

The Expert Tibial Nail PROtect, includ-ing its cannulation, is coated with athin layer (approximately 50 μm) of antibiotic-laden polymer.


PROtect impedes bacteria from adher-ing to the implant surface and produc-ing biofilms. It releases high doses ofantibiotics where systemic admissioncannot reach (local concentration is upto 1000 times higher than in systemicapplication).5 It is highly local with nodetectable systemic side effects.

PROtect– protection frombacterial colonization

The coating is abrasion resistant andwill withstand most of the forces occurring during nail insertion.

The coating releases the antibiotic im-mediately after implantation for theduration of approximately 2 weeks. It iscompletely resorbed after approxi-mately 6 months.*

� PROtect antibiotic coating

� Coated medical device

� Bacteria

� Dead bacteria

*Resorption time may vary depending on patient specific conditions.

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Prevents bacterial colonization on the implant surfaceAntibiotic 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.


Features and Benefits

Antibiotic coating with no systemic side effectsVery low levels of antibiotic in the blood serum.

Enhances safety in higher risk patientsAntibiotic prophylaxis from within the bone.

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Antibiotic release

Safety and Effectiveness

The coating is completely resorbable. The antibiotic is re-leased within the first hours and days after implantation, asschematically shown below:

The initial release creates high concentrations of the antibiotic agent. It is released at the right time, in sufficientamounts 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 toolin infection prevention.

*Compared to other methods

Implantation Days Weeks

Release of gentamicin

100

80

60

40

20

0

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*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 formetaphyseal and certain intraarticular fractures of the tibial head and the pilontibiale:− 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 withother implants:− 41-C1/C2− 43-C1/C2


PROtect coating contains the antibiotic agent gentamicin.

Gentamicin has a proven record of success as the most com-monly used antibiotic for local application in combinationwith bone cement for prosthetics.5 It has a concentration-de-pendent bactericidal activity8 and does not cause one-step

The Expert Tibial Nail PROtect covers the same indications asthe Synthes Expert Tibial Nail (uncoated).** The use of an implant with PROtect coating must be individually assessedin each case. PROtect is especially well suited for all caseswith 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

PROtect coating–building on proven values

Intended use*

mutations;11 this reduces the risk of bacterial resistances. It is effective against the bacteria most commonly responsiblefor deep wound infection: Staphylococcus aureus, Staphylo-coccus epidermidis, and Pseudomonas. It has a low allergenic potential and shows a synergistic effect in combination withCephalosporins.11

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Preoperative (CT-scan)

Postoperative

Patient historyA 26-year-old male presented with polytrauma and perfo-rated chest trauma, dissection of the subclavian artery withthrombus, a crush injury of the lower right leg and a thirddegree open fracture of the right tibial shaft with suspectedvessel injury.

There was a high risk of infection due to very distressed softtissue in the fracture zone. An Expert Tibial Nail PROtect wastherefore used for the medullary nailing.

Surgical treatmentThe patient underwent a thoracotomy and a partialpneumectomy (left). This was followed by the application ofan 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-stagesurgery.


Clinical experience

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Follow-up (6 months after surgery)

Follow-up (3 months after surgery)

Postoperative treatmentSix weeks postoperatively, partial load bearing (20 kg) waspossible. Soft tissue at the perforation site closed, andthe patient regained free mobility of the knee and anklejoints. 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 under-went intensive ambulant physiotherapy and lymphaticdrainage.

Three months postoperatively, full load bearing was possible,the soft tissue completely healed, and the bony consolidationprogressed as expected. The patient returned to work on apart-time basis.

Six months postoperatively, the patient was pain free, withinconspicuous soft tissue scarring and free mobility of theadjacent joints. The patient resumed full-time work.

*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.

Surgeon comments“Open fractures and fractures with severe soft tissue damagepose 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 TibialNail PROtect allowed the single-stage exchange surgery from external to internal fixation.“

Clinical result*Length, axis and rotation were fully reconstructed, and thenail statically locked. The soft tissue regeneration and thebony consolidation led to complication-free fracture healing.


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In-vivo infection models have shown that the PROtect coat-ing prevents the proliferation of bacteria on the implant andits surrounding area.12

Tibiae of rats were infected with Staphylococcus aureus andnailed with either PROtect coated Kirschner wires or uncoated Kirschner wires.

Swabbing of the explanted PROtect coated Kirschner wires21 and 42 days after implantation showed a dramatic reduction of bacterial growth.

Effectiveness

Uncoated implant

PROtect coated implant

Images courtesy of Dr. T. Fuchs, Universitätsklinikum Münster, Germany.

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� 8 mm

� 9 mm

� 10 mm � 11 mm

� 12 mm

� 13 mm


Implants

Expert Tibial Nails with PROtect antibiotic coating,cannulatedOnly available in sterile packaging

Length � 8 mm � 9 mm � 10 mm(mm) dark blue dark blue 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 � 12 mm � 13 mm(mm) light green light green 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

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Bibliography

1 Espehaug, B, LB Engesaeter, SE Vollset, LI Havelin, N Lan-geland. “Antibiotic Prophylaxis in Total Hip Arthroplasty:Review of 10 905 Primary Cemented Total Hip Replace-ments Reported to the Norwegian Arthroplasty Register,1987 TO 1995.” J Bone Joint Surg 79 (4) (1997): 590-595.

2 Fluckiger, U, W Zimmerli. “Factors influencing antimicrobial therapy of surface adhering microorganisms.”Recent Res. Devel. Antimicrob Agents Chemother 4(2000): 165–175.

3 Vaudaux, P, DP Lew. “Tolerance of staphylococci to bactericidal antibiotics.” Injury 37 (2006): 15–19.

4 Gristina, AG, PT Naylor, QN Myrvik. “Musculoskeletal In-fection, Microbial Adhesion, and Antibiotic Resistance.”Infect Dis Clin North Am 4 (3) (1990): 391-408.

5 Diefenbeck, M, T Mückley, GO Hofmann. “Prophylaxisand treatment of implant-related infections by local appli-cation of antibiotics.” Injury 37 (2006): 95–104.

6 Harris, LG, RG Richards. “Staphylococci and implant surfaces: a review.” Injury 37 (2006): 3–14. application ofantibiotics.” Injury 37 (2006): 95–104.

7 Darouiche, RO. “Treatment of infections associated withsurgical implants.” N Engl J Med 350 (14) (2004): 1422–1429.

8 Richards, RG, LG Harris, E Schneider, N Haas. “Antisepticsand antibiotics on implants.” Injury 37 (2006): 113–116.

9 Stemberger, A, H Grimm, F Bader, HD Rahn, R Ascherl.“Local Treatment of Bone and Soft Tissue Infections withthe Collagen-gentamicin Sponge.” Eur J Surg Suppl 578(1997): 17–26.

10 Schmidmaier, G, M Lucke, B Wildemann, NP Haas. “Prophylaxis and treatment of implant-related infectionsby antibiotic-coated implants: a review.” Injury 37 (2006): 105–112.

11 Gilbert, D. “Aminoglycosides.” In: Mandell, Douglas, andBennett's Principles and practice of infectious diseases. ed-ited by G Mandell, J Bennett, R Dohlin, 279-306. ChurchillLivingstone, 2000.

12 Lucke, M, G Schmidmaier, S Sadoni, B Wildemann,R Schiller, NP Haas, M Raschke. “Gentamicin coating ofmetallic implants reduces implant-related osteomyelitis inrats.” Bone 32 (2006): 521–531.

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0123All technique guides are available as PDF files at www.synthes.com/lit

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