dgkh000173
10.3205/dgkh000173
urn:nbn:de:0183-dgkh0001736
Research Article
Titanium-copper-nitride coated spacers for two-stage revision of infected total hip endoprostheses
Titan-Kupfer-Nitrid beschichtete Spacer für den zweizeitigen Wechsel infizierter Hüftendoprothesen
Ellenrieder
Ellenrieder
Martin
M
Dr.
Orthopädische Klinik und Poliklinik, Universität Rostock, Doberaner Strasse 142, D-18057 Rostock, Germany, Phone: +49(0)381/494-9363, Fax: +49(0)381/494-9311Orthopädische Klinik und Poliklinik, Universität Rostock, Rostock, Germany
martin.ellenrieder@uni-rostock.de
author
Haenle
Haenle
Maximilian
M
Orthopädische Klinik und Poliklinik, Universität Rostock, Rostock, Germany
author
Lenz
Lenz
Robert
R
Orthopädische Klinik und Poliklinik, Universität Rostock, Rostock, Germany
author
Bader
Bader
Rainer
R
Orthopädische Klinik und Poliklinik, Universität Rostock, Rostock, Germany
author
Mittelmeier
Mittelmeier
Wolfram
W
Orthopädische Klinik und Poliklinik, Universität Rostock, Rostock, Germany
author
German Medical Science GMS Publishing House
Düsseldorf
610
total hip arthroplasty
infection
spacer
titanium-copper-nitride coating
Hüftendoprothese
Infektion
Spacer
Titan-Kupfer-Nitrid-Beschichtung
20111215
engl
1863-5245
6
1
GMS Krankenhaushygiene Interdisziplinär
GMS Krankenhaushyg Interdiszip
Prevention and therapy of nosocomial infections
16
Innerhalb der ersten beiden Jahre nach endoprothetischem Hüftgel<![CDATA[enker</PlainText></TextGroup>satz stellt die implantat-assoziierte Infektion mittlerweile den zweithäufigsten Grund für eine Revisionsoperation dar. Beim zweizeitigen septischen Wechsel werden temporäre Platzhalter (Spacer) aus antibiotikahaltigem Zement zur Therapie und Vermeidung einer bakteriellen Besiedlung verwendet. Mit dem Ziel, bekannte Nachteile von Zementspacern zu umgehen, wurde eine Biofilm-inhibierende kupferhaltige Beschichtung auf eine konventionelle Hemi-Endoprothese aufgebracht. Im Folgenden soll das Design dieses neuartigen Therapieansatzes im Rahmen eines Fallberichts vorgestellt werden. </Pgraph></Abstract>
<Abstract language="en" linked="yes"><Pgraph>Within the first two years after total hip arthroplasty implant-associated infection has become the second most common reason for a revision surgery. Two-stage implant exchange is frequently conducted using temporary spacers made of antibiotic-loaded cement in order to prevent a bacterial colonization on the spacer. Avoiding several disadvantages of cement spacers, a conventional hemi-endoprosthesis was equipped with a copper-containing implant coating for inhibition of bacterial biofilms. In the present paper details of this novel treatment concept are presented including a case report. </Pgraph></Abstract>
<TextBlock linked="yes" name="Introduction">
<MainHeadline>Introduction</MainHeadline><Pgraph>Due to the increasing number of primary joint arthroplasties as well as revision surgeries, implant-associated infections gain in medical and economic importance <TextLink reference="1"></TextLink>, <TextLink reference="2"></TextLink>. Multimorbidity and multiple previous revisions of the total joint replacement are major risk factors for infections. After insertion of an endoprosthetic implant the human cells and microorganisms compete for the colonization of the implant surface, which is called “race for the surface” <TextLink reference="3"></TextLink>. That process is a crucial point particularly for temporary spacer implants within two-stage total hip revisions in terms of septic implant loosening. Spacers consisting of bone cement can be hand-made by the surgeon with or without using casting moulds and metallic endoskeletons. As an alternative, preformed cement spacers are commercially available. Depending on the specific chemical composition, antibiotic loading and the geometry respectively surface of the applied bone cement (e.g. monobloc spacer, beads) the release of the antibiotics is highly variable. Hence, some authors report on antimicrobial effective concentrations of antibiotics even six weeks after cement spacer implantation <TextLink reference="4"></TextLink>, the majority of the studies showed a significant decrease of the release of antibiotics already after a few days <TextLink reference="5"></TextLink>, <TextLink reference="6"></TextLink>. As a consequence, the cement spacer itself may be colonized by residual bacteria. The portion of antibiotics in bone cement is limited, since it impairs the mechanical properties of spacers as well as of the cement mantle around endoprostheses <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>. The development of a metallic spacer with titanium-copper-nitride (TiCuN) coating should combine the superior mechanical stability of a total hip stem with a biofilm-inhibiting implant surface. </Pgraph></TextBlock>
<TextBlock linked="yes" name="Method">
<MainHeadline>Method</MainHeadline><Pgraph>Metallic spacers coated with TiCuN are used in patients with proven late periprosthetic infection according to i<TextGroup><PlainText>ntern</PlainText></TextGroup>ational criteria <TextLink reference="9"></TextLink>, <TextLink reference="10"></TextLink> as temporary implants within a two-stage revision concept. The total spacer interval is eight weeks. Tissue samples for a microbiological and histological examination are obtained before explantation of the infected total hip endoprosthesis, during implant removal, two weeks before reimplantation and within the reimplantation. The spacers are commercially available metallic hip stems and jumbo heads of different sizes and lengths (Figure 1 <ImgLink imgNo="1" imgType="figure"/>) with a polished surface which is coated by physical vapor deposition (PVD, DOT Coating, Rostock, Germany). The TiCuN coating is firmly connected to the implant surface <TextLink reference="11"></TextLink>. Titanium and copper are released from a target by electricity, ionized and deposited on the implant surface. That process leads to the formation of a face-centered cubic grid of titanium atoms with nitrogen ions embedded in the gaps. The TiCuN coating solely modifies the implant surface but leaves the mechanical properties of the implant unchanged <TextLink reference="11"></TextLink>. From the biological point of view, copper combines high antimicrobial respectively biofilm-inhibiting effectiveness with relatively little toxicity for human tissue when compared to other metal ions <TextLink reference="12"></TextLink>, <TextLink reference="13"></TextLink>. The TiCuN spacers are inserted after removal of the infected soft tissue and bone as well as the total hip endoprosthesis. In most cases the spacer can be implanted without additional cement fixation. If additional rotational or axial stabilization is required, a cement augmentation of the proximal implant part is performed (Figure 2 <ImgLink imgNo="2" imgType="figure"/>). Within the routine laboratory examination of the first and 14<Superscript>th</Superscript> postoperative day as well as after six weeks, the serum copper level is monitored. Six weeks after spacer implantation tissue samples from the affected hip joint are taken for a microbiological and histological examination by a mini-incision biopsy. In case of missing clinical, microbiological and histological signs of persistent infection, the reimplantation is performed after another two weeks. So far, the application was limited to selected patients. The clinical course of one patient is reported below.</Pgraph><SubHeadline>Admission situation (3/2010)</SubHeadline><Pgraph>67-year-old male patient with clinical signs of a loosening of his left total hip replacement (THR).</Pgraph><SubHeadline>Medical history</SubHeadline><Pgraph><UnorderedList><ListItem level="1">Primary THR 4/2004 (alio loco) because of hip dysplasia (Implants: thrust plate prosthesis (TPP), press-fit acetabular cup),</ListItem><ListItem level="1">since 6/2004: groin pain during walking and stair-climbing,</ListItem><ListItem level="1">9/2004: Loosening of the TPP. One-stage revision with removal of the TPP, implantation of a cemented hip stem, exchange of the polyethylene liner, leaving of the well-fixed acetabular shell. <Mark2>Histology:</Mark2> capsule <TextGroup><PlainText>with massive</PlainText></TextGroup> metallosis, no signs of an infection. <Mark2>M</Mark2><TextGroup><Mark2>icro</Mark2></TextGroup><Mark2>biology:</Mark2> no growth of bacteria after 14 days incubation. </ListItem><ListItem level="1">10/2004–2/2010: good clinical function of the THR,</ListItem><ListItem level="1">3/2010: Outpatient presentation reporting groin and thigh pain during walking for three weeks. <Mark2>Clinical findings:</Mark2> Scar and skin without irritation, no systemic signs of an infection. Thigh pain during compression. <Mark2>Radiological findings:</Mark2> extended osteolyses around the hip stem, breakage of the cement mantle (Figure 3 <ImgLink imgNo="3" imgType="figure"/>). Tissue samples were obtained (same-day surgery). <Mark2>Histology:</Mark2> scar tissue and neocapsule, no sign of an infection. <Mark2>Microbiology:</Mark2> <Mark2>Staphylococcus capitis</Mark2> (only fosfomycine resistance). <Mark2>Laboratory:</Mark2> chronic infection-associated anaemia, elevated infection parameters (Hb 5.6 mmol/l; WBC 13.1/nl; CRP 50.2 mg/l; BSR 17 mm/1 h).</ListItem></UnorderedList></Pgraph><SubHeadline>Diagnosis</SubHeadline><Pgraph>Based on the findings, the diagnosis of late implant-associated infection caused by <Mark2>S. capitis</Mark2> after aseptic total hip revision was made.</Pgraph><SubHeadline>Additional diagnoses</SubHeadline><Pgraph>Arterial hypertension, smoking (40 py), chronic peptic esophagitis, sigmoid diverticulitis (conservative treatment in 2006), cataract operation on both eyes in 2005. Risk classification (anaesthesia): ASA 2.</Pgraph></TextBlock>
<TextBlock linked="yes" name="Results">
<MainHeadline>Results</MainHeadline><SubHeadline>Course of treatment</SubHeadline><Pgraph><UnorderedList><ListItem level="1">4/2010: Explantation of the THR including a complete removal of cement, infected tissue and the proximal femoral bone. Implantation of a TiCuN coated hip stem as a temporary spacer (stem length 200 mm). A TiCuN coated jumbo head was used to complete the hemiarthroplasty (Figure 2 <ImgLink imgNo="2" imgType="figure"/>). <Mark2>Microbiology:</Mark2> <Mark2>Staphylococcus capitis</Mark2> (identical with preoperative biopsy)</ListItem><ListItem level="1">Antibiotic treatment for four weeks (cefuroxim/moxifloxacin, two weeks i.v. and two weeks p.o.)</ListItem><ListItem level="1">Postoperative serum copper levels: day 1: 18.4 µmol/l, day 14: 21.4 µmol/l and week 6: 19.1 µmol/l. <TextGroup><PlainText>Copper levels</PlainText></TextGroup> were within physiological range [11.0–23.5 µmol/l].</ListItem><ListItem level="1">Outpatient mini-incision biopsy six weeks after explantation: <Mark2>Histology/microbiology:</Mark2> no signs of a persisting infection. <Mark2>Laboratory:</Mark2> no signs of an infection (Hb <TextGroup><PlainText>8.3 mmol</PlainText></TextGroup>/l; WBC 7.4/nl; CRP <1.00 mg/l; BSR <TextGroup><PlainText>6 mm</PlainText></TextGroup>/1 h)</ListItem><ListItem level="1">6/2010: Cementless revision THR (Acetabular comp<TextGroup><PlainText>one</PlainText></TextGroup>nt: Metallsockel 2000, Orthodynamics, Luebeck, Germany; Femoral component: Restoration Modular Stryker, Mahwah, NJ, USA). <Mark2>Microbiology:</Mark2> Five tissue samples and PCR/culture of the spacer sonication fluid without detection of microorganisms </ListItem><ListItem level="1">7/2011: Clinical and radiological follow-up one year after reimplantation: no clinical or laboratory signs of a relapse of the periprosthetic infection. The X-rays (Figure 4 <ImgLink imgNo="4" imgType="figure"/>) show moderate ossifications of the soft tissue around the femoral diaphysis without clinical r<TextGroup><PlainText>eleva</PlainText></TextGroup>nce. No signs of implant-loosening or migration.</ListItem></UnorderedList></Pgraph></TextBlock>
<TextBlock linked="yes" name="Discussion">
<MainHeadline>Discussion</MainHeadline><Pgraph>The temporary insertion of cement spacers is a widely accepted procedure in two-stage septic arthroplasty revision to avoid soft-tissue contractures, to apply antibiotics locally and to facilitate the reimplantation <TextLink reference="14"></TextLink>. The addi<TextGroup><PlainText>tio</PlainText></TextGroup>n of antibiotics to bone cement is also practiced in conjunction with one-stage septic revisions when a cemented implant is used and the bacterial antibiogram is known <TextLink reference="15"></TextLink>. Additional mixing of antibiotics into bone cement intraoperatively reduces the mechanical resilience of the cement <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink> which may lead to breakage of the spacer <TextLink reference="16"></TextLink> or cement mantle around endoprostheses. Moreover, manual addition of antibiotics leads to a more varying agent release and the mixing as well as the polymerization may partially deactivate the antibiotics <TextLink reference="17"></TextLink>, <TextLink reference="18"></TextLink>. Cement spacers made with casting moulds and metallic endoskeletons provide a better mechanical stability <TextLink reference="19"></TextLink>. But any type of cement spacer may become colonized by bacteria <TextLink reference="20"></TextLink> when the antibiotic elution comes below the antimicrobial effective concentration <TextLink reference="5"></TextLink>, <TextLink reference="6"></TextLink>. The release of zirconium oxide particles from bone cement is a further disadvantage that received only little attention so far. Zirconium oxide particles are suspected to increase the wear rate of the following revision endoprosthesis <TextLink reference="21"></TextLink> caused by ceramic third body particles and hence to result in osteolyses and implant loosening <TextLink reference="22"></TextLink>. In order to avoid these disadvantages of bone cement spacers, several concepts of antiseptic or biofilm-inhibiting coatings were developed for metallic implants. Gollwitzer et al. and Vester et al. tested a biod<TextGroup><PlainText>egra</PlainText></TextGroup>dable poly(D,L-lactide) coating for binding antibiotics on metallic surfaces <TextLink reference="23"></TextLink>, <TextLink reference="24"></TextLink>. The clinical application of these PDLLA coatings is still limited due to a rapidly declining release of antibiotics and a poor mechanical stability of the coating <TextLink reference="23"></TextLink>, <TextLink reference="25"></TextLink>. As an alternative to antibiotics, metal ions are also known to show an antim<TextGroup><PlainText>icrob</PlainText></TextGroup>ial and biofilm-inhibiting effect. Silver containing coatings on titanium surfaces have been proven to be effective against <Mark2>Staphylococcus aureus</Mark2> and <Mark2>Staphylococcus epidermidis</Mark2> <TextLink reference="26"></TextLink>, <TextLink reference="27"></TextLink>. Gosheger et al. reported significantly less infections in an animal experiment with silver-coated implants compared to titanium-coated implants after inoculation of <Mark2>S. aureus</Mark2> <TextLink reference="28"></TextLink>. In the animals silver ion levels were elevated in the blood serum as well as in their organs <TextLink reference="28"></TextLink>. Since silver ions are known to be toxic to bacteria and human cells by induction of oxidative stress <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink>, F. Heidenau and W. Mittelmeier tested various other metal ions concerning their biocompatibility and antimicrobial activity <TextLink reference="12"></TextLink>. At the first step, mouse-fibroblasts and <Mark2>S. epidermidis</Mark2> were cultivated on culture media containing metal salts with differing concentrations of Ag<Superscript>+</Superscript>, Zn<Superscript>2+</Superscript>, Co<Superscript>2+</Superscript>, Al<Superscript>3+</Superscript>, Cu<Superscript>2+</Superscript> and Hg<Superscript>2+</Superscript>. Within a second setup, Ti6Al4V test specimens were sol-gel coated with these metal ions. Finally the colonization of the specimens by MC3T3-E1 cells and <Mark2>S. aureus</Mark2> was analyzed. In summary, compared to the other metal coatings, especially silver, copper showed a high antibacterial effectiveness in relation to its cytotoxicity <TextLink reference="12"></TextLink>. Haenle et al. confirmed antibacterial effects of Cu-TiO<Subscript>2</Subscript> coatings against MRSA <TextLink reference="31"></TextLink>. During bending and scratch tests with a single (1x Cu-TiO<Subscript>2</Subscript>) as well as fourfold (4x Cu-TiO<Subscript>2</Subscript>) coating thickness the layer showed a high mechanical stability without cracking or chipping-off <TextLink reference="31"></TextLink> which was confirmed in a test series using artificial bones. Moreover, different kinds of copper coatings manufactured with different procedures <TextLink reference="11"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink> are currently tested aiming towards future clinical use.</Pgraph></TextBlock>
<TextBlock linked="yes" name="Conclusion">
<MainHeadline>Conclusion</MainHeadline><Pgraph>Based on the first experiences, TiCuN-coated implants can be appropriate as temporary spacers for two-stage septic hip revision for selected patients. Concerning further application of those coatings for permanent endoprostheses (e.g. tumour implants) or articulating surfaces (e.g. knee endoprostheses) sufficient data are not available yet.</Pgraph></TextBlock>
<TextBlock linked="yes" name="Notes">
<MainHeadline>Notes</MainHeadline><SubHeadline>Acknowledgement</SubHeadline><Pgraph>The authors would like to thank DOT GmbH, Rostock, Germany for technical support as well as the Institut <TextGroup><PlainText>für Medi</PlainText></TextGroup>zinische Mikrobiologie, Virologie und Hygiene (Direktor: Prof. Dr. med. Dr. rer. nat. A. Podbielski) and the Institut für Pathologie (Direktor: Prof. Dr. med. A. Erbersdobler) for the microbiological and histological analyses. </Pgraph><SubHeadline>Competing interests</SubHeadline><Pgraph>The authors declare that they have no competing interests.</Pgraph></TextBlock>
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<Caption><Pgraph><Mark1>Figure 1: TiCuN coated (DOT GmbH, Rostock, Germany) hip stem and jumbo head for a hemiarthroplasty</Mark1></Pgraph></Caption>
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<Caption><Pgraph><Mark1>Figure 2: TiCuN-coated spacer implant. Additional cement augmentation (at the femoral diaphysis) for improved rotational and axial stability after resection of the proximal femur</Mark1></Pgraph></Caption>
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<Caption><Pgraph><Mark1>Figure 3: Chronically septic loosening of a cemented hip stem with extended osteolyses, breakage of the cement mantle and migration of the total hip stem</Mark1></Pgraph></Caption>
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<Caption><Pgraph><Mark1>Figure 4: Cementless total hip revision implant: radiological follow-up 1 year after implantation</Mark1></Pgraph></Caption>
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