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Ceramic Surface Engineered Metal-on-Metal

Hips system for Total Hip Arthroplasty and


Resurfacing
Ceramic Surface Hip Arthroplasty
Engineered Metal-on-Metal The
The design rationale, pre-clinical testing
and interim report on 2- 7 years of clinical results
By Karel J Hamelynck MD PhD and Ron G. Woering

The ACCIS®system for total hip arthroplasty (THA) and resurfacing hip arthroplasty (RHA) consists of metal
components for the reconstruction of the acetabulum and metal femoral head components for conventional
THA and RHA. The ACCIS®metal components are made of a chrome-cobalt-molybdenum alloy, but are differ-
ent from other metal-on-metal prostheses. The surfaces of the metal components are engineered with the
ceramic Titanium-Niobium-Nitride (TiNbN) in order to minimize metal particulate wear, to prevent corrosion
and to prevent metal ion release.

introduction lubrication at the dome of the articulation and wide enough to


In the recent past metal-on-metal hip arthroplasty has prevent equatorial impingement. Current mechanical loosening
attracted the renewed interest of the orthopedic world, when is probably caused by insufficient primary fixation. Most cup
polyethylene wear and subsequent osteolysis were recognized designs are spherical. These spherical cups run the considerable
as important causes of failure of hip implants (1-3) and excellent risk of being pushed out of the acetabulum due to forces around
long term results of some original metal-on-metal prostheses the whole cup after impaction, called “the rebound effect”
without any obvious wear and without osteolysis were Press fit fixation by equatorial over-sizing as seen in cups with
demonstrated (4). New prostheses were designed with a metal- a three radial design is enhanced by compression forces only
on-metal articulation and 28 mm femoral heads (5). and is probably more reliable.
An old dream of “surface replacement” in the hip became a
reality when metal was used for material, resulting in minimal metal ion release
bone resection of the acetabular and femoral side (6). Metal bearings corrode at a rate determined by their surface
The larger diameter of the femoral head provided the hip joint area and cause a release of metal ions. When wear particles
with improved stability and increased range of motion (7-9). are being formed, the total surface area of metal is increased
As a result of the early success of surface replacement hip considerably. These ions may attach to proteins and cause
arthroplasty total hip systems were also designed with large allergic reactions (1,19-21). Hypersensitivity reactions of
femoral heads. surrounding tissues were described. (22-25). High blood levels
of chrome and cobalt were found in patients with metal-on-
metal particles metal prostheses and changes in red and white blood cells have
So far the good story. Soon after the introduction of new been reported (24,26-43). High metal ion levels are important,
metal-on-metal hip prostheses serious concerns about the knowing the fact that chrome and cobalt may cause cancer and
presence of metal degradation products in or near the hip may be mutagenic although investigations are not conclusive
joint or disseminated into the body were expressed in the about the relation with orthopedic implants (43,44).
literature(10). It became clear that metal-on-metal articulations,
despite the fact that the volumetric wear is less, may generate conclusion
more wear particles (3,4). Metal wear particles, much smaller Despite the fact that metal surfaces of prosthetic components
than polyethylene particles can be ingested by histiocytes for total hip replacement demonstrate less wear than surfaces
and macrophages and may become biologically active (11,12). of polyethylene, there is sufficient reason to try and reduce
Tumour-like proliferations of soft tissues around the hip were wear of metal components further, because a relatively high
reported. (13-18). amount of submicron size metal particles is generated, that may
become biologically active and may jeopardize the success of
fixation of all metal acetabular components the implant.
Lack of fixation of the acetabular component was a frequent A treatment to prevent corrosion of the metal surfaces is also
complication of the original metal-on-metal hip prostheses and needed in order to inhibit the formation of free metallic ions,
is a remaining problem today. The problem was then caused by which will be disseminated into the body with unknown
a variety of reasons: insufficient surgery, impingement by the effects. The mere presence of un-physiologically high serum
femoral neck, deformation of the sometimes very thin cup and levels of cobalt and chromium in the blood of patients after
high frictional torques caused by insufficient clearance between metal-on-metal hip arthroplasty remains a matter of concern.
the femoral and acetabular component especially at the equator. The question is “Can we take the risk of using metal-on-
Today with improved manufacturing capabilities clearances metal prostheses knowing that increase of metal ion levels is
can be made small enough to allow fluid film or mixed a fact?”

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Ceramic Surface Engineered Metal-on-Metal Hips system for Total Hip Arthroplasty and Resurfacing Hip Arthroplasty

The ACCIS®prosthesis system Preventing rebound :


The ACCIS®hip prosthesis system for conventional total hip The press fit fixation by equatorial over-sizing is different from
arthroplasty and surface replacement arthroplasty is especially the fixation principle of over-sizing with spherical cups. While
designed to overcome the possible disadvantages of metal-on- spherical cups run the considerable risk of being pushed out of
metal articulations. the acetabulum due to the forces around the whole cup, called
the rebound effect (46) , fixation of cups with equatorial

Fig. 2: ACCIS®Triple Radius Design

over -sizing is enhanced by compression forces only (figure 3).


Fig. 1: ACCIS®Resurfacing Hip assembled Two fins are added near the equator of the ACCIS®acetabular
components to support rotational stability (arrow in figure 2 ).
Manufacturing of the ACCIS®components The cup coverage angle is incrementing from 9.31mm, for the
The ACCIS®prosthetic components are manufactured from small size acetabular component 42mm (which is seldom used),
hi-carbon cobalt-chrome-molybdenum alloy according to till 16.24mm, for the larger component with the cup size 64 mm.
the ISO standard 5832-4. The components are casted, cooled
and then undergo a heat treatment. During the heat treatment
block-carbides, which are found at the metal surfaces of the
components and may cause abrasive wear in metal-on-metal
prostheses, are reduced in number and size. After heat treatment
the surfaces are polished. The next step in manufacturing is a
very important one: surface micro finish. After this treatment
the components are completely smooth, any remaining
asperities are at nanometer level. At this point the surfaces of
the ACCIS®prosthesis undergo another treatment: surface
engineering using the ceramic Titanium-Niobium-Nitride.
The TiNbN is integrated into the metal surfaces by physical
vapor deposition (PVD). The value of PVD technology lies in
its ability to modify the surface properties of a device without
changing the underlying material properties and biomechanical
functionality. In addition to enhanced wear resistance, PVD Fig. 3 The rebound forces in a hemispherical design (left)
coatings reduce friction, are compatible with sterilization and an equatorial press-fit design (right)
processes and improve corrosion resistance.
The outside of the cup is coated with a plasma spray of pure
Titanium (cpTi) according to the ISO standard 5832-2.
Acetabular components for THA and RHA: The pore diameter is 75-350 micron, the coating thickness
The acetabular cup has a tri-radial outside geometry (fig. 2). 300 +/- 50 micron and the roughness RA is 50 micron.
The main sphere (b) is purely spherical. At the pole (a) there
is a small area which is relatively flat (has a smaller radial The solidity of the fixation is specified as Rh = 45 MPa, while a
diameter). Near the equator (c) the cup is incrementally widened minimal strength of 22 MPa is required according to the “FDA-
1.6 – 2.1 mm. This equatorial oversizing provides excellent Guidance for the industry”.
press fit fixation provided the cup is well surrounded by pelvic The metal surface of the inner side of the acetabular component
bone. There will be line-to-line contact between the large is engineered with the ceramic TiNbN by PVD.
middle sphere of the cup providing excellent circumstances for
secondary bone in-growth.

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The design rationale, pre-clinical testing and interim report on 2- 7 years of clinical results

Cementless and cemented The small central stem does not contribute to the fixation
It is the aim to use the non-cemented cup in most THA’s and (no cement should enter the prepared canal), but serves as a
RHA’s. However a cemented cup is available for less than positioner for the head component.The articulating side of the
optimal bone conditions (picture 4 ) head component is engineered with the ceramic TiNbN by
PVD.

Femoral components for THA


ACCIS®femoral heads for total hip replacement are available
in sizes 38 to 58mm in 2mm increments; the neck length of the
femur may be adjusted with cone adaptors in three sizes: short
(-4mm), standard (0mm) and large (+4mm); the cone adaptor
is made of a Titanium alloy and has standard a 12/14mm cone.
(figure 6)

Fig. 4 ACCIS®Cemented Acetabular Component

The clearance between acetabular and femoral head


components is approximately 100 microns in all sizes.

Fig. 6 ACCIS®Large head and cone adaptor for THA


The femoral component for RHA
The purely spherical femoral head component is designed for Component sizes
cemented fixation. The inside of the femoral head component
has a 1 mm clearance at the top of the head. There is some
clearance around the head incrementing from a proximal
0.1mm tight fit towards distal 0.9 – 1.4mm clearance to give

Fig. 5 ACCIS®Cemented Femoral Component

space to an adequate cement mantle. Radially placed cement


pockets at the proximal part of the femoral head (figure 5)
provide room for additional cement, which contributes to the
quality of the fixation with cement.

Fig.7 ACCIS®component sizes

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Ceramic Surface Engineered Metal-on-Metal Hips system for Total Hip Arthroplasty and Resurfacing Hip Arthroplasty

How does the ceramic work? capable of slicing asperities off as small particles; this prevents
The surface modification of the metal components serves two the breaking away of carbides and the initial high wear of
objectives: the minimization of wear and the prevention of metal-on-metal articulations is to a large extent reduced. After
corrosion. the running in phase the opposing surfaces are completely flat
and show minimal wear.
1. The minimization of wear
To understand the effect on wear of a TiNbN coating it is 2. prevention of corrosion
important to know how M-on-M prostheses wear. Most wear Coating of implants with Titanium niobium nitride may also
in metal-on-metal articulations occurs in the first few millions prevent metal ion release by “isolating” the components.
of cycles of weight bearing (47). During this running-in phase There is no contact with the synovial fluids that are
surface asperities are worn flat. These asperities on metal contributing to corrosion. As a result no metal ions are
surfaces are formed by block carbides. produced. In vitro studies support this belief (48).
Block carbides are molecules formed from metal atoms and
carbon; a typical structure is M7C3. They are formed during Pre-clinical testing and results
the cooling phase of the metal component and are particularly Pre-clinical testing of the ACCIS®prosthesis consisted of
common at the surface. The molecules are relatively large: several tests of the fixation of the ceramic to the components,
20 – 30 microns. Their presence in the alloy makes the wear tests, corrosion tests, biological testing of the ceramic
alloy less homogeneous and weaker, but they are more wear TiNbN, and several tests of the fixation of the acetabular
resistant. The presence of block carbides in the metal alloy thus component.
imparts both advantages and disadvantages.
The block carbides are much harder than their housing alloy,
1. fixation of the coating
and may cause abrasive wear on the other opposing prosthetic
During the application of the TiNbN ceramic by PVD the
surface. Asperities may also break free from the surface and
ceramic is integrated into the surface. To test the fixation of the
cause three-body abrasive wear.
coating several tests were performed:
To minimize the disadvantages it is possible to reduce the
- pin-on-disc test: the test revealed no dislodging nor
number and size of the carbides present. Heat treating the
scratching of the coating (49).
component after the cooling process leads to the presence of
- bending test; no delamination of the coating did occur (50)
fewer carbides, with remaining molecules reduced in size to
- Rockwell test: no delamination of the coating did occur (51)
5 – 10 microns. This process leads to retention of block carbide
advantages, while reducing disadvantages.
A ceramic coating is helpful to further reduce the disadvantages 2. wear tests
of block-carbides. Ceramics have the advantage of being Wear evaluations using hip simulators were performed by
extremely hard. In the ACCIS®surface replacement prosthesis independent investigators at the Institut für Materialforschung
the ceramic titanium-niobium-nitride is used to reinforce the und Anwendungstechnik, IMA in Dresden, Germany (52 ,53),
articulating surface and to reduce wear of the chromium- and at the Atomic Energy Authority in Harwell, UK (62 ):
cobalt-molybdenum alloy. ACCIS®ceramic coated MoM hip implants with femoral head
components of 42 and 46 mm were compared to prostheses
with bearing surfaces of metal-on-polyethylene, ceramic-on-
polyethylene and metal-on-metal.
These studies resulted in the following conclusions:
- the wear of the TiNbN-coated ACCIS® prostheses was
limited to the running in phase: partial removal of the ceramic
coating occurred during the initial 1- 2 million cycles after
which removal was neglible (54).
- during the running-in phase TiNbN-coated prostheses
showed a 6-10 fold reduction of wear compared to M-on-M
articulations with 32 mm femoral head components(54).
- the ceramic layer was intact after 5 million cycles
following the running-in phase.
Fig. 8 Hardnesses of various orthopaedic alloys - hip simulator tests comparing ACCIS®ceramic coated
and ACCIS®non-ceramic coated components confirmed
The titanium-niobium-nitride coating is very wear resistant, the beneficial effect of the ceramic coating.
and being much harder than the block carbides (figure 8) is - shed particles were shown to be of sub-micron size: < 0.1µ

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The design rationale, pre-clinical testing and interim report on 2- 7 years of clinical results

3. corrosion testing absence of any increase of metal ions in the blood of patients
At the University of Würzburg the release of chromium ions after THA and SRHA with the ACCIS®prosthesis.
was measured by placing a ceramic coated CoCrMo prosthetic
component and a non-ceramic coated CoCrMo prosthetic
1. fixation of the cup
component in a boiling saline solution for 240 hours. A 90%
reduction of chrome ion release with the TiNbN coated The first clinical trial was performed at the Slotervaart
component was demonstrated (55). The TiNbN coating provides Ziekenhuis, Amsterdam, the Netherlands ( Karel J. Hamelynck
a great amount of protection against corrosion. MD PhD and Paul Winia MD). From March 2000
till September 2002, 80 ACCIS®total hip replacements were
4. biological testing performed using a prototype spherical ACCIS®cup with a
Biocompatibility testing was performed at the LPT Laboratory casted porous coating and three fins at the dome to enhance
of Pharmacology and Toxicology, Prof.Dr.med F. Leuschner, rotational stability. This type of fixation demonstrated to be
in Hamburg Germany in order to investigate possible biological insufficient. The primary fixation of this cup appeared to
reactions to TiNbN when implanted into the body. be inadequate for two reasons. The adequate seating of the
- implantation test according to the USP XXII following the spherical slightly over-sized cup may have been hindered by
LPT protocol 7362/92. Result: No difference in tissue reaction the so-called rebound effect (46 and figure 3). Forces around
was found between Titanium-Niobium-Nitride ceramic the cup are pushing the cup out of the acetabulum leaving a
implanted in rabbits and negative control material. The effect gap between the acetabular bone and the component. The fins
observed was limited to a non-specific tissue reaction (56). at the dome of the cup may have contributed to the rebound
- examination for cytotoxic properties of plates made of effect. When primary fixation is inadequate, secondary fixation
CoCrMo coated with TiNbN in a cell culture test according may not occur.. The results caused a design change. The fins
to USP 28 and EN 30993-5. Result: no signs of cytotoxicity were abandoned and hydroxyapatite was added to improve the
were revealed, while the positive control revealed severe secondary fixation.(prototype 2)
cytotoxicity (57).
A second clinical trial was performed at the Morriston
Hospital, Swansea, Wales (UK), David J Woodnutt, MD FRCS,
5. tests for the fixation of the cup
FRCS (Orth). Between April 2003 and December 2003 sixty
The primary fixation of the tri-radial design of the
THA’s were performed using prototype 2 ACCIS®spherical
ACCIS®acetabular component for cementless press-
cementless acetabular component. The results of this trial
fit application and the fixation of the spherical
revealed again the negative influence of the rebound effect
ACCIS®component for cemented fixation were tested at the
on primary fixation, which is typical for the spherical cup
Technical University Hamburg-Harburg (Prof. Dr.habil. M.M.
design. For that reason the shape of the cup was changed from
Morlock). To determine the ideal external configuration pull-
purely spherical to tri-radial with a small flattened part at the
out, cantilever and rotational stability tests were performed
dome and a peripheral widening at of 1.7 – 2.0 mm at the
and various types of surface geometries for the acetabulum
equator. The fixation of this tri-radial cup design during testing
components were compared. The triple-radius design with
demonstrated a press-fit fixation that was clearly superior to the
equatorial over-sizing and two equatorial fins gave optimal
fixation of spherical designs. The best results were achieved
primary stability and became the definitive design (58).
when two fins were added at the equator (58) The tri-radial
The pure Titanium plasma sprayed outer surface was selected,
shape became the definite shape of the ACCIS®cementless
because of its excellent contribution to primary fixation and
acetabular pressfit cup.
proven bone in-growth capacity.
The acetabular components do not deform during implantation.
The third clinical trial was again performed at the Morriston
The impaction of cups into the pelvis of a calf was tested
Hospital, Swansea, Wales (UK). Starting from April 2005 a
at the Technical University Hamburg-Harburg. Result: the
great number of total hip replacements and surface replacement
deformation of the cup, which may result from impaction of
arthroplasties has been performed using the definite press-fit
the ACCIS®acetabular component, is neglectable, no decrease
tri-radial acetabular component. To date no problems with the
in function of the MoM articulation has to be expected; the
fixation of the cup have been encountered.
strength of the cup is adequate (59)
From 2006 more RHA trials using the ACCIS®prosthesis with
the definite acetabular component have been performed. No
Clinical results of the ACCIS®prosthesis
problems with fixation of the cup have been reported except
In this paragraph special attention is given to those aspects of
for the occasional early fixation problem due to surgical error.
the ACCIS®prosthesis, that are specific for its design. More
Surgeons needs to follow the precise surgical technique: the
common aspects like clinical function and hip scores are being
equatorial press fit fixation of the cup functions best, when the
published in the literature. This paragraph is focussed on (1)
cup is completely surrounded with acetabular bone.
fixation of the cup, (2) the absence of metal wear and (3) the

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Ceramic Surface Engineered Metal-on-Metal Hips system for Total Hip Arthroplasty and Resurfacing Hip Arthroplasty

integrated into the metal surfaces by physical vapor deposition


2. the absence of wear to minimize wear and to prevent corrosion as well.
The metal surfaces of the ACCIS prosthesis are engineered Blood tests of metal ion levels of 30 patients from the second
with the ceramic Titanium-Niobium-Nitride (TiNbN). TiNbN is trial at the Moriston Hospital, Swansea, UK, 2-5 years after
integrated into the metal surfaces by physical vapor deposition THA with the ACCIS acetabular and femoral head components
to minimize wear. with femoral heads of 42 and 46 mm or more demonstrated,
- failure of cup fixation in patients of the first trial at the that none of the patients had metal ion levels, that were
Slotervaart Ziekenhuis Amsterdam, the Netherlands, gave elevated 2-5 years after ACCIS THA (figure 10).
the opportunity of examining the capsule and soft tissue from The metal ion levels were equal to the average metal ion levels
behind the cup in 15 patients: examination of the biopsies in controls without a prosthesis shown by a dotted line in figure
demonstrated the complete absence of any adverse reactions to 10 (60,61). Patients with a titanium femoral stem had no increase
metal particles: no signs of hyper-sensitivity, necrosis, pseudo- of metal ions at all, while patients with a cobalt-chromium-
tumour formation and no signs of inflammation (figure 9). molybdenum femoral stem had some increase of chromium
ions.

The metal ion concentration of patient with an Accis THA


median Chromium: 3.61 (0.25-8.5) and median Cobalt: 1,3
(0,25-2.2)60) show
significant lower
levels of metal ions
than levels published
in other studies such as
by Langton (62) median
Cr: 3.42 (1,5-69,8),
median Co: 1,99 (0,4
Fig. 9 Histology of a retrieval at 44 Months -271) and by De Smet
(63): median Cr 13,2

(0,4-93) and median


- during the third clinical trial at the Morriston Hospital, Co 5,8 (1 – 94) And
Swansea, UK, no problems originating from the TiNbN this despite the fact
ceramic coating have occurred. that most of the THA
- all components revised for whatever reason, have been patients had CoCrMo
studied extensively by implantcast GmbH, the manufacturer of femoral stems (60) !
the prosthesis. No errors of manufacturing could be detected.
The TiNbN coating remained intact and present around the full
femoral head and inside of the acetabular component with the Fig.10 Metal ion levels after Total Hip Arthroplasty
exception of a very small area at the dome of the cup in some
cases, demonstrating the effect of running in. A clinical multi-centre follow-up study on 200
ACCIS®Resurfacing implants (Morriston Hospital, Swansea,
UK: David J Woodnutt, MD, FRCS, FRCS (Orth); Neville Hall
comment: Hospital, Abergevanny, UK: Robin Rice, MD,BMBS,FRCS;
Some wear does occur during the running in phase of any Arthro Clinic Hamburg: Genio Bongaerts, MD) is performed.
metal-on-metal prosthesis. Fluid-film lubrication cannot be Blood samples of 60 patients are analysed before, immediately
achieved in all prostheses. In most prostheses there will be after surgery and at intervals of 3, 6, 12 and 24 monts after
initial contact at the dome due to the diametrical clearance surgery.
between head and cup. With the ACCIS prosthesis this running
in wear is limited to the running-in period. However the The results of this ongoing study are shown in figure 11.
presence of the coating around the whole femoral head and the None of the patients at any moment after operation has shown
almost complete inside of the cup guarantees that corrosion any significant increase of cobalt and chrome ions in the blood
cannot occur. and none of the blood ion levels has been above the normal
limits for metal ions in the blood as described in the Hand book
3. the absence of any increase of metal ions in the for environmental medicine (61).
blood
The metal surfaces of the ACCIS prosthesis are engineered
with the ceramic Titanium-Niobium-Nitride (TiNbN). TiNbN is

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The design rationale, pre-clinical testing and interim report on 2- 7 years of clinical results

The conclusion is justified that corrosion of the articular (1) the primary fixation of the acetabular component is very
surfaces of the metal components of the ACCIS®prosthesis reliable due to the tri-radial design, equatorial press fit and TPS
by the process of surface engineering of the surfaces with the coating.
ceramic TiNbN, is completely (2) ceramic engineering of the
inhibited. articular surfaces of the metal
Early clinical results were components causes a minimization
presented at various of metal wear.
meetings (60,64-66) . (3) corrosion of the metal surfaces
The above mentioned study will be is prevented and reduced to the
finished in the 4th quarter of 2009 minimum.
and subsequently published.
There is no need to fear for
conclusions: increased levels of metal ions
The components of the in the blood and the un-known
ACCIS®system for THA and RHA consequences of this increase.
incorporate important advantages
over other metal-on-metal hip October 4th 2009
prostheses with large femoral
heads:

Fig. 11 Metal ion levels after Resurfacing

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”Inflammatory pseudotumor associated with femoral nerve palsy following “Increased blood cobalt and chromium after total hip replacement. “Clinical
metal-on-metal resurfacing of the hip”. J Bone Joint Surg Am. 2008;90:1988-93 Toxicology 1999;37:839-844

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Ceramic Surface Engineered Metal-on-Metal Hips system for Total Hip Arthroplasty and Resurfacing Hip Arthroplasty

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ACCIS®components are manufactured and distributed by:


implantcast GmbH
Lüneburger Schanze 26
D-21614 Buxtehude
Germany
Phone:+ 49-4161 744 100 Homepage: www.accis.nl
E-mail: info@implantcast.de contact the author: accis.resurfacing@gmail.com

White Paper Published August 2009

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