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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.
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.
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
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
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:
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