Pourous Coatingsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...The result is a high porosity,...

Pourous CoatingProduct Rationale

Introduction 2

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

Contents

GRIPTION exhibits “a superior scratch fit

leading to increased primary stability”

due to one of the industry’s highest

coefficients of friction.10-12

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.

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.

DePuy Synthes GRIPTION Product Rationale2

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 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 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.


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 experience.1-9

POROCOAT is supported by multiple 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 National

Joint Registry for England, Wales, Northern Ireland

and the Isle of Man reported 97.19% survivorship

at 10 years for ceramic on polyethylene bearings

and 96.84% survivorship at 10 years for metal on

polyethylene bearings.18 POROCOAT Porous Coating

is found on a range of contemporary DePuy Synthes

Joint Reconstruction products.

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% volume porosity at the

surface an average pore size of 250 microns”, 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 Mpa

to minimise coating delamination. The coating process

has an average thickness of 0.762 (± 0.254 mm).

This tolerance variance is intentional because it adds

to the overall roughness of the coating. Research20

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.


Built on the Foundations of POROCOAT

Characteristic POROCOAT10 GRIPTION10,13,21,22

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

GRIPTION Porous Coating builds on the characteristics of POROCOAT and hence

emulates some of its proven properties:

• GRIPTION has a pore size of 300 microns13,21 versus 250 microns for

POROCOAT. 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

reconstitution.15 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.22

• 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.10,13,21

• 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 porosity (80-percent at the surface)”13

Comparison of the physical characteristics of POROCOAT and GRIPTION porous coatings

* 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.


Super Textured Asperity TopographyGRIPTION incorporates a proprietary 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


The proprietary 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.19 Bearing this in mind, a superior coefficient of friction and therefore enhances 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.

Definition of Coefficient of Friction

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.

High Coefficient of Friction

Coefficient of Friction

GRIPTION10 TRITANIUM12 TRABECULAR

METAL11

1.2

1.0 1.0


A property that is proprietary to DePuy Synthes porous

coatings is its gradient porosity13 (see chart right).

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.15,23 The outermost pores are

typically filled with scraped bleeding bone upon

impaction of the component.

GRIPTION is engineered to maintain a 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

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.

Gradient, High Volume Porosity

Gradient Volume Porosity13

The volume of porosity increases as the distance from

the cup surfaces increases.

Surface Volume Porosity

GRIPTION13 TRITANIUM12 TRABECULAR

METAL11

~80%

~72%

<80%

100

90

80

70

60

50

40

30

20

10

0

Vo

lum

e P

oro

sity

(%

)

Distance from the substrate (µm)

0 250 500 750 1000


Optimal Pore Size

GRIPTION has an average pore size of 300 microns,13,21 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

Definition of Pore Size

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).

→ GRIPTION Porous Coating has an average pore size of

300 microns.13,21

Op

tim

al Po

re S

ize

50

-40

0 µ

m

Optimal Pore Size

GRIPTION13,21 TRITANIUM12 TRABECULAR

METAL11

~300 µm

~546 µm ~550 µm


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.


Manufacturing Process

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

Clinical Applications

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. Kindsfater 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. Onodera 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.

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 Ten-

Year Duration of Follow-Up. J Bone Joint Surg Am 1998;80-A:952-960

10. DePuy Internal Test Report: WR070146; 2007.

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

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.

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. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man,

13th Annual Report, 2016. Table 3.9. Available from www.njrreports.org.uk

19. Ayers RA, et al. Quantification of bone ingrowth into porous block

hydroxyapatite in humans. J Biomed Mater Res.1999: 47(1):54-59.

20. DePuy Internal Test Report: Master File 60.

21. DePuy Synthes Data on File, Master File 1478.

22. DePuy Synthes Data on File, WR070087,070065.

23. DePuy Synthes Data on File: Strength of GRIPTION Porous Coating.

©Johnson & Johnson Medical Limited. 2017. All rights reserved.

Johnson & Johnson Medical Limited PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom.

Incorporated and registered in Scotland under company number SC132162.

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The third party trademarks used herein are the trademarks of their respective owners.

This publication is not intended for distribution in the USA.

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