BIOLOX deltaof PE, XPE and metal (left). Only an unscratched, smooth surface of the sort achieved in BIOLOX® ceramics enables optimal wetting, outstand-ing lubrication and minimal

CeramTec Medical Products

BIOLOX®delta

Scientific Information and Performance Data

2 Tribology and Arthroplasty

Key Issues in Hip Arthroplasty

Osteolysis

Although total hip arthroplasty is one of the most successful of all surgical procedures, a

number of open questions relating to implant design and materials remain. According to

the Swedish Register (2012), osteolysis and aseptic loosening are responsible for 68.2

percent of all revisions. The bearing materials used and the volume, size, and biological

effects of wear particles play a decisive role in the development of these conditions. The

second most frequent complication is dislocation created by prosthetic impingement and

insufficient joint stability.

Instability

Component impingement can result in a limited range of motion (ROM). In addition to exact

implant positioning, the technical ROM achieved after implan tation plays a crucial role. While

large ball head and cup-liner diameters increase ROM, they are associated (in the case of PE, XPE

and MoM) with an increased volume of wear particles. In a metal-on-metal articulation this can

result in an elevated level of metal ions released into the surrounding tissues. Both mechanisms

have been the subject of intense scientific discussion.

Hypersensitivity

The incidence of hypersensitivity and al lergic reactions to metals is increasing in the world’s

industrialized countries. The possible onset of hypersensitive reactions in patients treated

with metal-on-metal bearings cannot be completely ruled out in advance. Metal allergies

detected post surgery represent an additional burden for patients and insurers. It has

therefore become even more important to use implant materials that exhibit a biologically

compatible behavior in the body.

3Tribology and Arthroplasty 3

Synovial Fluid Lubrication

There remains a limited understanding of the actual processes governing the tribological

performance of artificial joints. Unlike natural cartilage, even modern material combina-

tions do not allow for a permanent lubrication film to separate the two surfaces. For that

reason wear-resistant materials with optimal surface characteristics play a key role in deter-

mining the tribological outcome of arthroplasty.

Taper Corrosion

Corrosion at the head-neck taper has recently been found to be an important factor for

the outcomes of THA, and its severity is multi-factorial. There is increasing evidence that in

addition to wear reduction, ceramic femoral ball heads are also crucial in mitigating metal

taper corrosion on the stem side, while experiencing no corrosion themselves.

4

5Competence in Ceramics

Proven High Performance CeramicsBIOLOX®delta

More than 40 years of experience in ceramic hip replacements together with more

than 11 million BIOLOX® implanted components confirms CeramTec as a world

leader in this technology.

Surgeons all over the world put their faith in CeramTec’s pink-colored BIOLOX®delta

ceramic. This colour gives surgeons the certainty that they are using implants of the

highest quality and reliability for their patients – from CeramTec.

BIOLOX®delta is the only ceramic with 11 years of successful clinical experience and

with more than 5 million implanted components.

Ceramic components made of BIOLOX® owe their superior

properties to a unique material composition, the most

modern production techniques and a multi-stage, com-

prehensive system of quality control.

Comprehensive quality control – 3D measurement of ball heads

6 Material Properties

Extreme Hardness The purest raw materials and a manufacturing process that has been

refined over decades ensure the highest degree of material uniformity, mechanical prop-

erties and perhaps most importantly, hardness. This results in excellent wear resistance.

Exacting Sphericity The femoral ball heads are produced in highest precision to assure-

that the articulation design produces the least amount of wear possible.

Optimal Clearance An exact, defined clearance between the BIOLOX® ball head and the

BIOLOX® cup liner ensures excellent lubricating and gliding properties, minimal wear and

outstanding functionality.

Superior Surface Smoothness Precisely executed final polishing gives the ceramic com-

ponents the lowest surface roughness of all implant materials. The highly polished sur-

face of BIOLOX® components demonstrates an average surface roughness of only around

2 nanometers.

Nearly no Third-Body Wear Unsurpassed hardness leads to nearly no surface damage

to the articulation by third-body wear in ceramic-on-ceramic bearings. Foreign particles

are broken down and extruded.

Scratches Cement particles and surgical instruments are not able to scratch ceramic sur-

faces – an important advantage when using cement and minimally invasive procedures.

Excellent Biological Behaviour Clinical experience shows no long-term adverse reac-

tions to ceramic particles. Ceramic materials are biologically inert and exhibit unmatched

biocompatibility and no known side-effects.

Supreme Wettability Hydrogen bonds with ceramic surfaces ensure excellent wetta-

bility and the formation of an effective lubricating film.

Proven High Performance Ceramics

Text: CeraNews 2/2010 – Usbeck 7

Text: CeraNews 2/2010 – Usbeck

Superiority in Extreme Conditions

Scratched surfaces increase abrasion in cup liners made of PE, XPE and metal (left).

Only an unscratched, smooth surface of the sort achieved in BIOLOX® ceramics enables optimal wetting, outstand-ing lubrication and minimal wear (right).

Foreign particles that are harder than the bearing sur-face lead to high levels of wear (left).

Surfaces made of high per-formance ceramics remain largely unchanged (right).

Polyethylene

Metal

Ceramic

Ceramic

Material Properties

Source: CeramTec GmbH

Hydrogen bonds with ceramic surfaces ensure excellent wet-tability and the formation of an effective lubricating film.

Source: CeramTec GmbHSource: CeramTec GmbH



8

9

Metal bonding: irregular electron orbitals permit the formation of ions (left).

Ceramic bonding: tight electron orbitals largely rule out ion formation and chemical reactions (right).

Atomic nucleus

Electron

9

Source: CeramTec GmbH Source: CeramTec GmbH

Loose Metal Structure

The molecular structures of metal alloys and ceramic materials are fundamentally dif-

ferent. In the case of a metal bond, the electrons orbit the atomic nuclei in an irregular

manner and with relatively low bonding strength. As a result of this, metal ions contin-

uously exit this molecular structure and are absorbed by the surrounding tissues. This

occurrence can result in many different chemical and biological reactions.

Stable Ceramic Structure

In ceramic molecules, the electrons follow exact orbital paths. The electrons’ bonding

strength is very high, making the molecules themselves extremely stable. This prevents

ion forma tion and chemical and biological reactions within the body.

Molecular Bonding

Material Properties


The extremely stable ceramic bond virtually rules out any possibility of plastic defor-

mation. While this permits the desired degree of extreme hardness, it also leads to a

relatively high degree of brittleness. How ever, by optimising the ceramic composition

one can achieve both extreme hardness and strength. Such composite models exist in

nature and in modern technology.

Damascene steel combines hard and ductile alloys to form a high-ly firm and resistant material.

The protective pearl shell com-bines hardness and strength. It consists of hard-brittle aragonite and very elastic layers of protein and chitin.

Hardness and Toughness Combined

Source: stienenDamast, Mönchengladbach, Germany Source: J.D. Verhoeven, A.H. Pendray, W.E. Dauksch, Journal of Metals, vol. 50, No. 9, p. 60 (1998)

Source: CeramTec GmbH Source: CeramTec GmbH

11

Text: CeraNews 2/2010 – Usbeck12

The MULTIGEN PLUS Ceramic Knee (Limacorporate, top)

The BPK-S Ceramic Knee (Peter Brehm GmbH, middle, bottom)

13Material Properties

Intelligent Reinforcement Mechanisms

A Fundamental Difference

Material sciences make a distinction be tween fracture strength and fracture tough-

ness. Fracture strength is the maxi mum mechanical stress a material can withstand

without fracturing. Fracture toughness is the resistance of a material to the propa-

gation of cracks. Ceramic materials that have been in use for a number of years,

such as BIOLOX®forte, already have a very high fracture strength.

BIOLOX®delta additionally exhibits an extremely high fracture toughness. It has a

much higher capacity than other ceramic materials to resist the onset of cracking

and to arrest the propagation of cracks. This property is based on two strengthen ing

mechanisms.

Strength under Peak Stress

The highest degree of material stress in hard-on-hard bearings occurs in small di a-

meters. Here, the strength of BIOLOX®delta offers an extra benefit: the well proven

aluminum oxide (more than 80 percent by volume) ensures uncompromising hard-

ness. Additional ceramic reinforcement elements ensure the material’s high resis-

tance against fracture and crack propagation.


Airbag Function

The first strengthening mechanism is de rived

from the dispersion of tetragonal zirconium oxide

particles in the microstructure. These particles,

which are homogenously distributed throughout

the stable aluminum oxide matrix, produce local

pressure peaks in the area of cracks and thereby

counteract their propagation.

Counteracting Crack Formation

The second strengthening mechanism is the

result of in situ formation of platelet-shaped

crystals in the oxide mixture. These platelets

reduce cracking and crack propa gation by neu-

tralizing the crack energy. As a result of these

strengthening mechanisms, BIOLOX®delta al-

lows implant designers to create component

geometries that were not possible with previous

ceramic materials.

Optimized Microstructure

1 2

3

2 µm

Aluminum oxide

Crack propagation

Zirconium oxide

Crack propagation

Platelet

The microstructure of BIOLOX®delta: platelets with crack-stopping function (1), alu-minum-oxide particle (2), zirconi-um-oxide particle (3). Significantly smaller grain size and higher uniformity (compared to BIOLOX®forte, left) make even smoother surfaces possible and enhance the material properties.

The principle of conversion re-inforcement: zirconium oxide particles act like airbags by ab-sorbing impacting forces (left).

The principle of platelet rein-forcement: platelet-shaped crystals block the propagation of cracks and thereby increase overall strength (right).

2 µm





Text: CeraNews 2/2010 – Usbeck 15


Long-lasting Strength

Improved Properties

The burst strength test assesses ceramic components by exposing them to axial loading

until the point of material failure. Ball heads made of BIOLOX®delta (28mm) resist loads

of more than 80 kN when tested. Larger ball heads show an even higher burst strength.

The burst strength of BIOLOX®delta is considerably higher than that of conventional

aluminum oxide ceramics. Furthermore, tests on standard material

samples show that the bending strength of BIOLOX®delta is not

adversely affected by repeated autoclaving. While hydrothermal

instability can occur in objects made of pure zirconium oxide, such

instability does not arise due to the alumina matrix present in

BIOLOX®delta.

Enhanced Biomechanical Properties

The advantages of ceramic materials are especially apparent in large diameters

(≥32mm). Simulator studies show that the rates of wear remain low despite the signifi-

cantly larger friction surfaces, i.e. significantly lower than those of other materials. With

ceramic components, surgeons are no longer forced to compromise wear rates and di-

ameter, and can instead choose the best option for their patients.

Better Tribology

Dramatically reduced wear, enhanced range of motion and increased resistance to dislo-

cation make this bearing the number one choice when it comes to functional improve-

ment, durability and safety. In contrast to bearings with conventional and highly cross-

linked polyethylene, the rate of wear does not increase for ceramic-on-ceramic bearings

in the case of larger diameters. This leads to a superiority to all other bearing materials.

8t

Burst stress to ball head – loads of up to ten tons are introduced via the cone.

Burst strength comparison: Burst strength is the point at which the component breaks. This corresponds to a force of more than 8 tons in the case of a ball head made of BIOLOX®delta (left).

BIOLOX®delta shows after 10 hours of autoclaving no changes during the burst test compared to a brand-new ball head.

Source:CT

0

40

20

60

80

1 2 3 4 5 6 7

100

Burst strength (kN)

Number of tests (7 ball heads)0

40

20

60

80

1 2 3 4 5 6 7

100

Burst strength (kN)

Number of tests (7 ball heads)

36mm36mm0

4

2

6

8

10

12

Volume wear rate (mm3 per million cycles)

Alumina ceramicfemoral ball head on XPE

Metal femoralball head on XPE

28 mm 36 mm0

4

2

6

8

10

12




Negative effect of increased metal head size (left): hip joint simulator – highly crosslinked polyethylene, long-term wear rate after 10 million cycles

Positive effect of alumina ceramic ball head compared to metal femoral ball head (right): hip joint simulator – highly crosslinked polyeth-ylene, long-term wear rate after 10 million cycles.

Source: Fisher J, University of Leeds (UK), 2006

Negative Positive

36mm36mm0

4

2

6

8

10

12


Alumina ceramicfemoral ball head on XPE


28 mm 36 mm0

4

2

6

8

10

12




0

40

20

60

80

100

Burst strength (kN)

10 autoclave hoursPristine

0

40

20

60

80

100

Burst strength (kN)

10 autoclave hoursPristine

17Material Properties

The strengths of BIOLOX®delta18

New Geometries

The superior material properties of BIOLOX®delta permit component geometries that were not

possible with previous ceramics. Cup liners with thinner wall thickness are still able to offer in-

creased stability and safety as they allow the use of ceramic-on-ceramic bearings in larger diame-

ters. In contrast to metal and polyethylene, ceramic bearings with larger diameters show no sig-

nificantly increased rates of wear.

Precise Lubrication Clearance

A further advantage of thin-walled ceramic components is the material’s high stiffness. This en-

sures that the precisely adjusted lubrication clearance be tween the components, which is neces-

sary for the formation of a lubricating film, is not compromised by any deformation in the thin-

walled elements.

Sizes and Material Combinations

The composition of BIOLOX® ball heads and cup liners permits any bearing combination of

BIOLOX® forte and BIOLOX®delta from a tribological point of view. Ball heads made of both ma-

terials can also be combined with cup liners made of polyethylene and highly crosslinked poly-

ethylene, specifically designed and approved/cleared by the authorities for this combination.

More Options

BIOLOX® ball heads must only be used in combination with femoral stems and stem tapers specifically designed by the implant man-

ufacturers in cooperation with CeramTec and approved/cleared by the Authorities for this combination. BIOLOX® inserts must only

be used in combination with acetabular shells specifically designed by the implant manufacturers in cooperation with CeramTec and

approved/cleared by the Authorities for this combination. BIOLOX®OPTION ball heads and sleeves must only be used in combination

with femoral stems and stem tapers specifically designed by the implant manufacturers in cooperation with CeramTec and approved/

cleared by the Authorities for this combination. BIOLOX®DUO Bipolar systems must only be used in combination with BIOLOX®forte

and BIOLOX®delta ball heads specifically designed by the implant manufacturers in cooperation with CeramTec and approved/cleared

by the Authorities for this combination.

Important: Please keep in mind that there is no international standard defining the design of the stem taper or their nomenclature.

For this reason any reference to stem tapers such as 12/14,10/12 etc. does not necessarily mean that their design is identical.

From the tribological point of view, BIOLOX®forte, BIOLOX®OPTION and BIOLOX®delta ball heads can only be used in combination

with BIOLOX®forte or BIOLOX®delta inserts or PE or XPE inserts in combinations which are specifically designed by the implant manu-

facturers in cooperation with CeramTec and approved/cleared by the Authorities for this combination.

1919

Text: CeraNews 2/2010 – Usbeck20

21The strengths of BIOLOX®delta

Optimized Revision

BIOLOX®OPTION offers a suitable solution for the rare case of ceramic component

fracture. The ceramic revision femoral ball head (BIOLOX®OPTION) helps to signifi-

cantly reduce the rate of wear-related osteolysis following revision hip arthroplasty.

In the case of an acetabular cup revision, the surgeon has the option to use a CoP,

CoXPE or CoC bearing when a firmly fixed stem remains in situ.* Thus, a bearing

couple can be implanted as an upgrade solution which exhibits a greater degree of

wear resistance than the bearing couple used for primary hip arthroplasty.

Knee Arthroplasty

The geometry of bearings used in knee arthroplasty is significantly more complex

than that of the hip joint. The improved material properties of BIOLOX®delta have

made it possible to manufacture safe ceramic components for such geometries.

Shoulder Arthroplasty

Polyethylene wear, loosening, metal allergy and infection are among the greatest

problems in shoulder arthroplasty which makes the use of BIOLOX® ceramic mate-

rials a logical choice. Introducing BIOLOX® ceramics into shoulder arthroplasty will

extend the clinical applications of these materials.

Application Diversity

* The stem taper deformations are described in IFU BIOLOX®OPTION.

22 The strengths of BIOLOX®delta

The Strengths of BIOLOX®delta

• Excellent biological behaviour*

• Significantly low taper corrosion*

• No metal ion release*

• No known pathogenic reaction to particles*

• Resistant to third-body wear*

• Excellent wettability*

Our customers from the medical devices industry are constantly enquiring about new

capabilities and uses of bioceramics. The most urgent requests are for wear debris

reduction, improving imaging, preventing microbial contamination and providing

options for patients with hypersensitivity to metals. Bioinert ceramic components

offer proven and potential approaches to solving these problems, and are the focal

point of our research and development. The goal of CeramTec Medical Engineering is

to create ceramic products for new medical treatment options in areas such as spine,

small joints, and dental products.

Further Applications

*References available on the file at CeramTec GmbH on request

23

CeramTec GmbH

Medical Products Division

CeramTec-Platz 1–9

D-73207 Plochingen

Tel. +49 7153 611 828

Fax +49 7153 611 950

E-Mail: [email protected]

www.biolox.com

This document is intended exclusively for experts in the field, i.e. physicians in particular, and is expressly not for the information of laypersons. The information on the products and / or procedures

contained in this document is of a general nature and does not represent medical advice or recommendations. Since this information does not constitute any diagnostic or therapeutic statement

with regard to any individual medical case, individual examination and advising of the respective patient are absolutely necessary and are not replaced by this document in whole or in part. The

information contained in this document was gathered and compiled by medical experts and qualified CeramTec employees to the best of their knowledge. The greatest care was taken to ensure the

accuracy and ease of understanding of the information used and presented. CeramTec does not assume any liability, however, for the up-to-dateness, accuracy, completeness or quality of the infor-

mation and excludes any liability for tangible or intangible losses that may be caused by the use of this information. In the event that this document could be construed as an offer at any time, such

offer shall not be binding in any event and shall require subsequent confirmation in writing. Some products are not approved for use in US or other countries. Please ask your Sales Representative if

the products are available in your market. (Review: January 2015)

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Scan the QR code to learn more about BIOLOX® high performance ceramics

Literature:

Affatato S, Modena E, Toni A, Taddei P. Retrieval analysis of three generations of BIOLOX® femo-ral heads: Spectroscopic and SEM characterisation. J Mech Behav Biomed Mater 2012;13C:118-128.:118-28.

Benazzo F, Rossi S, Piovani L, Russo C. Ten years of experience with ceramic-ceramic bearing in Total Hip Arthroplasty. In: The Journal of Bone and Joint Surgery (Proceedings) 93-B ed, 2011:154-d.

Cai P, Hu Y, Xie J. Large-diameter Delta Ceramic-on-ceramic Versus Common-sized Ceram-ic-on-polyethylene Bearings in THA. Orthopedics 2012;35:e1307-e1313.

Hamadouche M, Zaoui A, El Hage S, Letienne M, Boucher F, Mathieu M, Courpied JP. The in vitro and in vivo Safety of 22.2 mm Alumina Matrix Composite Ceramic Femoral Ball Heads. A Prospective Evaluation. In: Cobb J, ed. Modern Trends in THR Bearings: Material and clinical performance: Springer, 2010:157.

Hamilton WG, McAuley JP, Dennis DA, Murphy JA, Blumenfeld TJ, Politi J. THA with Delta ceramic on ceramic: results of a multicenter investigational device exemption trial. Clin Orthop Relat Res 2010;468:358-66.

Lombardi AV, Jr., Berend KR, Seng BE, Clarke IC, Adams JB. Delta Ceramic-on-Alumina Ceramic Articulation in Primary THA: Prospective, Randomized FDA-IDE Study and Retrieval Analysis. Clin Orthop Relat Res 2009.

Maurer-Ertle W, Friesenbichler J, Liegl-Atzwanger B, Kuerzl G, Windhager R, Leithner A. Nonin-flammatory Pseudotumor Simulating Venous Thrombosis After Metal-on-Metal Hip Resurfacing. Orthopedics 2011 2011;34:678.

Meftah M, Ebrahimpour PB, He C, Ranawat AS, Ranawat CS. Preliminary clinical and ra-diographic results of large ceramic heads on highly cross-linked polyethylene. Orthopedics 2011;34:e133-e137.

Pan T, Zhao ZL, FU DL, WANG HL, GUO B. The early clinical efficiency and experience in ap-plication of Delta ceramic-on-ceramic total hip arthroplasty. Journal of Clinical Orthopedics 2011;02/2011.

Raman R, Johnson G, Sharma H, Gopal S, Shaw C. Big balls - the ceramic experience. In: JBJS (Proceedings) 93-B ed, 2011:222-c.

Raman R, Johnson G, Sharma H, Gopal S, Shaw C, Singh J. Functional and clincal outcome of cementless primary arthroplasty of the hip using large diameter ceramic bearing couples. In: JBJS (Procceedings) 93-B ed, 2011:220-b.

Stafford GH, Islam SU, Witt JD. Early to mid-term results of ceramic-on-ceramic total hip replace-ment: ANALYSIS OF BEARING-SURFACE-RELATED COMPLICATIONS. Journal of Bone and Joint Surgery - British Volume 2011;93-B:1017-20.

Walter WL, Esposito C, Roques A, Walter WK, Zicat B, Tuke M, Walsh WR. Implant Retrieval Analy-sis of Biolox Forte vs. Biolox Delta Ceramic Femoral Heads: 2 Years Results [abstract]. AAOS 2011 Proceedings 2011;Poster No. 045:491.

Whittingham-Jones P, Mann B, Coward P, Hart AJ, Skinner JA. Fracture of a ceramic component in total hip replacement. Journal of Bone & Joint Surgery, British Volume 2012;94-B:570-3.

Dower B, Grobler G, Nortje M, Reid C. Deltamotion [abstract]. Bone & Joint Journal Orthopaedic Proceedings Supplement 2013;95-B:54.

Jack CM, Molloy DO, Walter WL, Zicat BA, Walter WK. The use of ceramic-on-ceramic bearings in isolated revision of the acetabular component. Bone Joint J 2013;95-B:333-8.

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BIOLOX deltaof PE, XPE and metal (left). Only an unscratched, smooth surface of the sort achieved in BIOLOX® ceramics enables optimal wetting, outstand-ing lubrication and minimal