GRIPTION ® Product Rationale

This publication is not intended for distribution in the USA.
PRODUCT RATIONALE
CONTENTS
Introduction2
Proven Clinical Heritage of POROCOAT®4
Built on the foundations of POROCOAT
5
Super Textured Asperity Topography (STAT) 6
High Coefficient of Friction
7
Gradient, High Volume Porosity
8
Optimal Pore Size
9
Manufacturing Process
10
Clinical Applications
12
GRIPTION Product Rationale DePuy Synthes
1
GRIPTION® porous coating is an evolutionary
development in implant fixation technology designed for
patients with an additional need of initial stability or a
diminished implant contact area with the host bone.
Introduced in 1977, POROCOAT porous
coating has more than 30 years of
clinical experience.1-9 In 2009 GRIPTION
porous coating was introduced
to build on the foundation of the
POROCOAT porous coating.
2
DePuy Synthes Joint Reconstruction GRIPTION Product Rationale
GRIPTION exhibits a superior ‘scratch fit’
leading to increased primary stability
due to one of the industry’s highest
coefficients of friction.10-12
GRIPTION porous coating’s advanced structure is called
‘Super‑Textured Asperity Topography’ (STAT) and is a random array of
sintered, irregularly shaped, commercially pure titanium (CPT) particles
forming a three-dimensional network of interconnecting pores.
GRIPTION exhibits a proprietary gradient
porosity which is engineered with a
clinically advantageous 80-percent
surface volume porosity designed
to facilitate bone in-growth13,14 and
a favorable mechanical loading
environment for bone formation.15
GRIPTION has an average pore size
of 300 microns13,23 which lies within
the optimal range for tissue in
growth into the structure and enables
vascularisation.14,16
GRIPTION Product Rationale DePuy Synthes
3
PROVEN CLINICAL HERITAGE
POROCOAT Porous Coating is a small-beaded,
metal surface coating that sits proud on the surface
of the implant and is designed for long-term
cementless fixation.
Introduced in 1977, POROCOAT porous coating
has more than 30 years of clinical experience1-9 and
surgeons continue to trust the three-dimensional
sintered bead coating structure. POROCOAT is
supported by many peer reviewed published clinical
papers reporting excellent results which is a testament
to this well established technology.1-9 Peer-reviewed
surgeon series of acetabular cups with POROCOAT
porous coating show excellent survivorship rates.1,2,4
100% of DURALOC® acetabular implants had bone
ingrowth into the porous-coated surface, with 0%
aseptic loosening at 16 years,1 100% survivorship
at 10 years of the DURALOC 300 cup2 and 96.1%
survivorship at 8 years with the PINNACLE cup.4
These results are supported by multiple National Joint
Registry results reporting 10-year survivorship rates
of DURALOC at 94% survivorship in the Norwegian17
registry. The Australian18 Joint Registry, 2013 reported
the DURALOC cup to have a 1.4% and 4.3% 10 year
cumulative incidence of revision for loosening and
lysis for crosslinked and non-crosslinked polyethylene
respectively. This performance is also documented
with the CORAIL PINNACLE construct results in the UK
registry with 97.38% survivorship at 8 and 9 years for
metal on polyethylene bearings.19 POROCOAT Porous
Coating is found on a range of contemporary DePuy
Synthes Joint Reconstruction products.
4
POROCOAT is made by sintering (high temperature
bonding) a random array of spherical beads of titanium
or cobalt chrome to an implant. The sintered beads
form a three-dimensional network of interconnecting
pores exhibiting optimal morphological properties
for bone in-growth. POROCOAT’s high coefficient of
friction of 0.810 provides a roughness that enables very
good initial stability and facilitates the ‘scratch fit’ of
the implant. It is engineered to provide a high and
clinically advantageous ~80-percent volume porosity
at the surface22 an average pore size of 250 microns,22
which is documented in a laboratory studies16 to
be within the beneficial size range for good bone
in-growth.
The three-dimensional, gradient structure of
POROCOAT Porous Coating is designed to provide
a favourable mechanical loading environment for
bone formation.15 POROCOAT Porous Coating
is manufactured with a coating tensile strength
>23 Mpa25 to minimise coating delamination. The
coating process has an average thickness of 0.762
(± 0.254 mm).25 This tolerance variance is intentional
because it adds to the overall roughness of the
coating. Research21 has demonstrated that virtually
all bone growth onto and into an implant is at the
outermost surface (only about 1-1.5mm deep into
the pore structure), which reinforces the design
characteristics of a sintered bead coating.
DePuy Synthes Joint Reconstruction GRIPTION Product Rationale
BUILT ON THE FOUNDATIONS OF POROCOAT
GRIPTION Porous Coating builds on the characteristics of POROCOAT and hence
emulates some of its proven properties:
• GRIPTION has a pore size of 300 microns13,23 versus 250 microns for
POROCOAT.22 Both POROCOAT and GRIPTION are documented in laboratory
studies14,16 to be within the beneficial size range for good bone in-growth and
vascular reconstitution.
• GRIPTION features a favourable three-dimensional, gradient structure, which
is designed to provide a favorable mechanical loading environment for bone
reconstitution15 The microtexture additionally enables greater cell adhesion and
proliferation due to its morphology.14
• GRIPTION’s manufacturing principles and mechanical attributes are virtually
identical to POROCOAT and therefore replicate many mechanical properties such
as the resistance to delamination with a coating tensile strength >32 Mpa.24
• The GRIPTION Porous Coating is applied by first preparing the surface of the cup
to accept a coat of the same spherical titanium beads as used for POROCOAT
Porous Coating. Once these spherical beads are applied to the surface, multiple
coats of irregularly shaped particles of titanium are applied directly over the top.
The result is a high porosity, high friction GRIPTION surface.10,13,23
• GRIPTION exhibits a high co-efficient of friction for initial ‘scratch fit’ designed to
increased primary stability based on one of the industry’s highest coefficients of
friction at 1.2.10-12
• GRIPTION is engineered to feature a clinically advantageous gradient and very
high volume porosity (80-percent at the surface).13
Comparison of the physical characteristics of POROCOAT and GRIPTION porous coatings
Characteristic
POROCOAT10,22,25
GRIPTION10,13,23,24
Pore Size (Gradient Pore Size)
~250 microns (average)
~300 microns (average)
Volume Porosity
~80% (surface),
45% (average)
~80% (surface),
63% (average)
Thickness
0.762 (average)
0.889 (average)
Coating Tensile Strength
>23 Mpa*
>32 Mpa*
Coefficient of Friction
0.8
1.2
* Actual values associated with failure of the coating were not obtained. The highest strength result obtained with no coating failure is indicated, as cohesive
failure occurred between the outer surface of the porous coating and the testing medium in all cases.
GRIPTION Product Rationale DePuy Synthes
5
SUPER TEXTURED
ASPERITY TOPOGRAPHY
GRIPTION incorporates a unique Super-Textured
Asperity Topography (STAT). STAT is a random array
of irregularly shaped, commercially pure titanium (CP
Ti) sintered particles forming a three-dimensional
network of interconnecting pores. STAT is comprised
of two differentiated structures; a macrotexture and
a microtexture.
The microtexture comprises a series of peaks and
troughs on the irregularly shaped titanium particles.
This microtexture may improve the osteoblasts’ ability
to stick to the surface, increasing adhesion strength
and enabling cell proliferation on the coating surface.14
6
DePuy Synthes Joint Reconstruction GRIPTION Product Rationale
HIGH COEFFICIENT OF FRICTION
The unique Super-Textured Asperity Topography (STAT) of GRIPTION Porous Coating features initial ‘scratch fit’
stability due to one of the industry’s highest coefficients of friction of 1.2.10-12
Implant micromotion exceeding 150 microns results in fibrous attachment and poor bone formation onto and
around an implanted device.20 Bearing this in mind, a superior coefficient of friction and therefore a better initial
‘scratch-fit’ stability may be crucial with regards to long-term fixation for a cementless implant. This may be
especially important with regard to cases with a smaller host bone contact area (this may include revision or unusual
primary cases), where the coefficient of friction may be an important factor for initial stability and long-term
fixation of the implant.
Coefficient of Friction
1.2
Definition of Coefficient of Friction
1.0
1.0
The Coefficient of Friction is defined by the ratio of the
force that maintains contact between an object and a
surface and the frictional force that resists the motion of
the object.
→ A Coefficient of Friction of 1.2 (GRIPTION Porous
Coating) implicates that for each 1 kilogram of weight
applied downward, it needs 1.2 kilograms of force to
dislodge it.
GRIPTION10
TRITANIUM12 TRABECULAR
METAL11
GRIPTION Product Rationale DePuy Synthes
7
GRADIENT, HIGH VOLUME POROSITY
Gradient Volume Porosity13
A property that is proprietary to DePuy Synthes porous
coatings is its gradient porosity13 (see chart right).
90
Volume Porosity (%)
GRIPTION like POROCOAT was designed with a
gradient porosity.13 The intent of this gradient porosity
is to assist with load sharing. The gradient coating
design gives rise to highest density of metal at the
substrate or surface of the cup and the lowest density
of metal at the outer surface of the coating.13 This
provides a smooth transition in porosity and metal
density as bone grows through the coating from bone
to substrate. The outermost surface of the coating
being more porous results in more open space for
vascurlarisation and good bone in growth. This gives
a strong bone-to-implant interface, and might aid in
stress shielding with the transition to lower porosity
providing a favorable mechanical loading environment
for bone formation.15,26 The outermost pores are
typically filled with scraped bleeding bone upon
impaction of the component.
100
80
70
60
50
40
30
20
10
0
0
250
500
750
1000
Distance from the substrate (µm)
The volume of porosity increases as the distance from
the cup surfaces increases.
GRIPTION is engineered to maintain a very high and
clinically advantageous 80-percent volume porosity13 at
the surface for good bone in-growth.14 This 80-percent
volume porosity is equal to or better when compared
to the volume porosity of other advanced coating
surfaces in the market.11-13
Surface Volume Porosity
~80%
<80%
~72%
Definition of Volume Porosity
Porosity is a measure of the void spaces in a material and
is a fraction of the volume of voids over the total volume,
expressed as a percentage between 0–100%.
→ A surface volume porosity of 80%13 (GRIPTION Porous
Coating) indicates, that 80% of the area is void space at
the bone implant interface.
GRIPTION13
8
DePuy Synthes Joint Reconstruction GRIPTION Product Rationale
TRITANIUM12 TRABECULAR
METAL11
OPTIMAL PORE SIZE
GRIPTION has an average pore size of 300 microns,13,23 which is documented in laboratory studies to be within the
beneficial size range of 50-400 microns for good bone in-growth and vascular reconstitution.16
Pores below 50 microns may hinder uniform maturation of tissue: in larger pores, 400 microns and above,
in-growth may be slow, inconsistent and tends to be fibrous.16
Optimal Pore Size
~546 µm
~550 µm
Definition of Pore Size
Optimal Pore Size
50-400 µm
Pore size is a measure of the average diameter of a
material’s pores (this usually includes a definition of the
range of pore sizes).
~300 µm
GRIPTION13,23
→ GRIPTION Porous Coating has an average pore size of
300 microns.13,23
TRITANIUM12 TRABECULAR
METAL11
GRIPTION Product Rationale DePuy Synthes
9
MANUFACTURING PROCESS
The manufacturing process for PINNACLE cups with GRIPTION Porous Coating is very similar to the
manufacturing process for coating with POROCOAT.
Raw Forging
The PINNACLE Shell forging is essentially a “blank” that can be
made into almost any PINNACLE cup design including the 100,
300, Sector, Multihole or Bantam series.
Outer Diameter Machined
The forging is machined at this stage to include the apical hole and
any screw holes.
GRIPTION Porous Coating Applied
The surface of the cup is prepared to accept a coat of the same
spherical titanium beads as used for POROCOAT Porous Coating.
Once these spherical beads are applied to the surface, multiple
coats of irregularly shaped particles of titanium are applied directly
over the top. The result is a high porosity, high friction GRIPTION
surface.10,13,23 (Were this a cup with POROCOAT Porous Coating,
only spherical beads would be applied.)
Inner Diameter Machined
Following the sintering process (sintering is the process of high
temperature bonding of the beads to the implant creating a strong
metallurgical bond between the implant and the fused beads), the
PINNACLE shell’s inner diameter is machined to accept the liners.26
Finished Pinnacle Cup
PINNACLE Cups with GRIPTION Coating are checked against
specification and are cleaned, boxed and sterilised.
10
DePuy Synthes Joint Reconstruction GRIPTION Product Rationale
GRIPTION Product Rationale DePuy Synthes
11
CLINICAL APPLICATIONS
There are three groups of patients that may stand to gain the most from GRIPTION’s high coefficient of friction,
high gradient volume porosity and optimal pore size:
• Atypical Primary Patients (in the case of a diminished contact area of the implant with the host bone)
This may include DDH, rheumatoid protrusio, prior fusion, severe natural anteversion or retroversion deformity,
or tumour.
• Traditional Revision Patients
This may include revisions of failed cemented cups, minor to moderate protrusio, migrated shell, osteolytic
defects and false acetabulum, where a loss of host bone may compromise primary fixation.
• Primary Patients with an Additional Need for Initial Stability
Any other primary patients where surgeons feel an improved initial scratch fit is of benefit.
12
DePuy Synthes GRIPTION Product Rationale
References
1. Kim Y-H, Kim J-S and Park J-W. Is Hydroxyapatite Coating Necessary to
Improve Survivorship of Porous-Coated Titanium Femoral Stem?J Arthroplasty.
2012;27:559-563.
2. Grobler GP et al. Ten-year results of a press-fit, porous-coated acetabular
component. J Bone Joint Surg Br 2005;87:786-9.
3. K indsfater K, Barrett WP, Dowd JE, Southworth CB and Cassell MJ. “99.9%
Midterm Survival of the Pinnacle Multi- Liner Acetabular Cup in a Prospective
Multi-Center Study.” Poster Presentation #P077, AAOS, San Diego, CA. February
14-18, 2007.
4. DePuy Orthopaedics, Inc. Internal Study Update. PINNACLE Multi-Liner Acetabular
Cup in a Prospective Multi-Center Study. May 2011.
5. Engh CA, et al. “Porous-Coated Total Hip Replacement.” Clin Orthop Rel Res.
1994;298:89-96
6. O
nodera S, et al. Cementless total hip arthroplasty using the modular S-ROM
prosthesis combined with corrective proximal femoral osteotomy. J Arthroplasty.
2006;21(5):664-9.
7. Cameron HU, Keppler L and McTighe T. The Role of Modularity in Primary Total
Hip Arthroplasty. J Arthroplasty. 2006;21 Suppl 1:89-92.
8. Chiu KY, et al. Cementless total hip arthroplasty in young Chinese patients: a
comparison of 2 different prostheses. J Arthroplasty. 2001;16(7):863-70.
13.DePuy Internal Test Report: WR070125; 2007.
14.Karageorgiou V, et al. Porosity of 3D biomaterial scaffolds and osteogenesis.
Biomaterials 2005;26:5474-91
15.Simmons, et al. Differences in osseointegration rate due to implant surface
geometry can be explained by local tissue strains. J Orthop Res 2001;19:187-194
16.Bobyn JD, Pilliar RM, Cameron HU, Weatherly GC. The optimum pore size for the
fixation of porous surfaced metal implants by the ingrowth of bone. Clin Orthop
Rel. Res. 1980;150:263-270.
17.Furnes O, et al. Prospective studies of hip and knee prostheses - the Norwegian
Arthroplasty Register 1987-2004. Scientific Exhibit presented at 72nd Annual
Meeting of the American Academy of Orthopaedic Surgeons, Washington, DC,
USA. Feb 2005.
18.Australian Orthopaedic Association National Joint Replacement Registry. Annual
Report. Adelaide: AOA; 2013. Available from URL: https://aoanjrr.dmac.adelaide.
edu.au/annual-reports-2013. Page 76.
19.National Joint Registry for England, Wales and Northern Ireland 10th Annual
Report 2013 Table 3.12.
20.Jasty M, et al. In vivo skeletal responses to porous-surfaced implants subjected to
small induced motions. J Bone Joint Surg Am. 1997;79(5):707-14.
21.Ayers RA, et al. Quantification of bone ingrowth into porous block hydroxyapatite
in humans. J Biomed Mater Res.1999: 47(1):54-59.
9. Burt CF, Garvin KL and Erik TA. Femoral Component Inserted Without Cement In
Total Hip Arthroplasty, A Study Of The Tri-Lock Component With an Average TenYear Duration of Follow-Up. J Bone Joint Surg Am 1998;80-A:952-960
22.DePuy Internal Test Report: Master File 60.
10.DePuy Internal Test Report: WR070146; 2007.
23.DePuy Synthes Data on File, Master File 1478.
11.Published literature: No.97-7864-001-00 7.5ML, Zimmer Inc, 2005 and Zimmer
Inc, Trabecular Metal Technology. Website accessed February 17, 2014 at URL
http://www.zimmer.com/en-US/hcp/hip/our-science/tm-technology.jspx
25.DePuy Synthes Data on File, 510(k) 934457.
12.Published data of the Stryker Orthopaedics Test Report RD-07-077. Website
accessed January 10, 2014 at URL http://www.stryker.com/en-us/products/
Orthopaedics/HipReplacement/PrimaryAcetabular/
TritaniumAcetabularShell/index‌.htm.
24.DePuy Synthes Data on File, WR070087,070065.
26.DePuy Synthes Data on File: Strength of GRIPTION Porous Coating.
DePuy Synthes Joint Reconstruction is a trading division of Johnson & Johnson Medical Limited
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