Porous Metallic implants used as bone fillers

Slide 2 -

Slide 3 - What is an implant?

“Implants are devices that are placed inside or on the surface of the body. An implant is
manufactured to
• replace a missing biological structure - Prosthetics

• enhance an existing biological structure – Cosmetic implants

• support a damaged biological structure - Sensory and neurological implants, Cardiovascular

medical devices, Orthopaedic implants

Applying my title: Porous Metallic implants used as bone fillers, the biological structure is BONE.

Slide 4 – Bone

So the question is Why a damaged bone needs support?

• Bone is a complex tissue continually undergoing dynamic biological remodelling

• Has the ability to remodel itself to repair damage

HOWEVER, when bone defect exceeds a critical non-healable size, external intervention is required.

Repair of critical-sized bone defects include

• Use autograft (patients’ own tissue) – Creates problems due to the need for second surgical
site
• Use allograft tissue (taken from another person) – Carries the risk of transmissible diseases
and also depends on logistic circumstances
• Use biomimetic materials and structures (implant) – due to insufficient application of
autograft and allograft, research led to identify biomimetic materials and structures that are
suitable for skeletal repair without any problems.
Thus, an implant must act as a bridge in order for the bone to heal. This implies that the implant
must mimic the bone’s
- morphology, structure, and function

Slide 5 – Bone: Morphology and Structure

• Bone is a natural composite, composed of

• an organic matrix (mainly type-I collagen)
• inorganic crystalline mineral - hydroxyapatite
accounting for about 95 wt. % of the dry bone.
• The macroscale level represents the overall shape of the bone – we can think of it as a solid!

• On the microscale level, bone is classified as

 • compact bone (cortical bone)

• trabecular bone (cancellous bone)

It has a honeycomb-like matrix internally, which helps to give the bone rigidity

Slide 6 – Bone: Morphology and Structure

• Trabecular bone
• large spaces in trabecular bone with cortical bone surrounding it

• The pores in trabecular bone are filled with bone marrow

• Porosity varies between 50-90%

• Pore sizes at the order of 1mm in diameter

Slide 7 – Bone: Morphology and Structure

• Cortical bone

• a solid structure with a series of voids, also known as canals

• Porosity varies between 3–12%

Slide 8 – Bone: Mechanical Properties

• Mechanical properties of bone depend on age, anatomical site and bone quality. 3, 5, and
35-year-old femoral specimens had modulus of elasticity values of 7.0, 12.8, 16.7 GPa,
respectively It is generally reported that, after maturation, the tensile strength and modulus
of elasticity of cortical bone decline by approximately 2% per decade.

• Compact bone is stronger and stiffer when loaded longitudinally than transverse directions.

• It is also stronger in compression than in tension. Bone has a compression strength

that is several times higher than that of concrete (70Mpa) and due to its porous
structure its density is only in the range of aluminium.

Ultimate Strength Modulus of Elasticity

Bone type Direction of load Type of Bone
(MPa) (GPa)
Tension 133 17.9
Longitudinal Compression 193 17.9
Cortical Bone Shear 63 3.3
Tension 51 10.1
Transverse
Compression 33 10.1
Trabecular
Axial 6.8 0.441
Bone

Slide 9 – Bone: Function

 • The main function of bones is to support and protect various organs in the body, provide
structure and support to the body itself. and additionally to produce cells, store minerals,
enable mobility

• Four cell types are present in bone tissue. These include

• Osteoblasts – to remodel by producing and mineralizing new bone matrix
• Osteocytes - maintaining the matrix
• Osteoclasts - resorbing the matrix
• Bone lining cells - inactive cells that are believed to be precursors for osteoblasts

This marks the necessity of having pores – to allow migration and proliferation, and vascularization of
osteoblasts.

Various hormones are also within the bone matrix to help in regulating bone metabolism, function
and regeneration.

Slide 10 – Requirements for an ideal Porous Implant

The complexity of architecture and the variability of properties of bone tissue (porosity, mechanical
properties), as well as differences in age, nutritional state, and disease status of individuals establish
a major challenge in fabricating porous implants.

• A porous implant would restore the function of bone and promote regeneration of bone tissue
at the damaged site.

• An ideal porous implant should possess the following characteristics:

• Biocompatibility
• To support normal cellular activity
• it must be osteoconductive and osteoinductive
• able to induce blood vessels formation within or around the implant
• it should be non-immunogenic
• suitable surface for cell attachment
• mechanical properties to match the requirements of the surrounding tissues
to reduce / eliminate stress shielding, and avoid mechanical failure. Bone responds to the
absence and presence of physical load. In response to these loads, the body either resorbs
or forms bone.
• to be highly porous with an interconnected pore network for cell ingrowth and
transport of nutrients and metabolic waste;

So know knowing the requirements for an ideal porous implant, the question remains Why Porous
implants intended for bone defects are made from metal?

Slide 11 – Porous Metallic Implants

Why Porous implants intended for bone defects are made from metal?

• Ceramics portray excellent corrosion resistance

 • BUT cannot be employed as load bearing implants, due to their intrinsic brittleness

• Polymeric systems are easily manipulated and allow better reproduction (The physical
characteristics of the polymers can be altered based on their use as their composition may
be changed easily. Polymers can be changed in to more porous or softer form)

• BUT cannot sustain the mechanical forces present in bone, and lack adhesion to
living tissue

• In biomedical applications, Weber and White et al. were the first to mention the use of
porous metals for osseointegration, direct structural and functional connection between
living bone and the surface of a load-bearing artificial implant.

• leading research to focus on porous metal implants due to

• Superior fracture properties

• Fatigue resistance characteristics, which are required for load-bearing applications.

Slide 12 – Porous Metallic implants: Classifications

- Pore type
• Open-cell Porosity
• Closed-Cell Porosity
- Types of metallic porous implants:
o partly or fully porous-coated solid substrates;
o fully porous materials;
o porous metal segment joined to a solid metallic part.
- Material of implant
• Stainless steels
• Cobalt-chromium
• Titanium
• Tantalum

Slide 13 – Porous Metallic implants: Pore

• Closed-cell Pores

o each cell is completely enclosed by a thin wall or membrane of metal

o result of a random foaming process with

 limited porosity

 variations in pore size and shape

• Open-cell Pores

o individual cells are interconnected allowing tissue to infiltrate the foam and anchor
it into position.
This marks the necessity of having open cell pores – to allow migration and proliferation, and
vascularization of osteoblasts.

The choice between open and closed pores relies on the type of application and site.

Slide 14 – Different types of Porous Metallic Implants

• It is recognised that there are three distinct types of porous implants:

o partly or fully porous-coated solid substrates
o fully porous materials
o porous metal segment joined to a solid metallic part

• Applications using porous-coated or / and fully porous implants. These include:

o fracture plates
o wires, pins and screws
o Hip nails
o fixtures related to orthopaedic structures [1]
This type of porous material is necessary because the mentioned application are inserted through
bone, so having a pores structure will promote bone ingrowth, and transfer of nutrients

Slide 15 – Different types of Porous Metallic Implants

• Implants with solid cores and porous coating structures

o appropriate when the porous metal alone does not provide sufficient mechanical
strength to sustain the loading, such as in:
o dental implants,
o joint arthroplasty implants [1]

Slide 16 – Porous Metallic implants: Material of Implant – Stainless Steel

• The first reliable metals used as prosthesis in orthopaedics due to

◦ being strong
◦ superior corrosion resistance than Iron
• The most common stainless steel in orthopaedics is designated 316L.
• Advantages
◦ Desired mechanical strength
◦ Easy manufacturability
◦ Good tolerance in most patients
• Stainless steel is mostly suitable in temporary devices such as
◦ fracture plates,
◦ screws,
◦ hip nails
◦ other integrated fixtures tied to primarily orthopaedic structures.

Slide 17 – Porous Metallic implants: Material of Implant – Stainless Steel

• Disadvantages

◦ heavier and much stiffer than bone (250 GPa vs 18 GPa for cortical bone)
 • leads to larger stress shielding of the surrounding bone tissue and larger chances
for local bone demineralization near steel implant installations

◦ not completely resistant to corrosion in the dynamic physiological environment.

◦ on prolonged exposure to body fluids, elements like Ni, Co and Cr tend to leach out
causing toxicity

These disadvantage were very evident a clinical experiment was conducted

• Clinical Experimentation using Stainless Steel porous implant

• Between September 1995 and December 1996, 42 patients (between 20-50 years of
age who suffered femoral fractures) were treated with femoral 316L porous
stainless steel nails [2]

Where this type of nail was approved by the Food and Drug Administration-approved.

The results were collected over a 21-month period and only 27 of the 42 patients participated in
analysis. (27 were chosen according to gender and how serious of a fracture they had)

Slide 18 – Porous Metallic implants: Material of Implant – Stainless Steel

Good news 26 of the patients healed

• Results – fretting corrosion of the femoral nail which caused

o osteolysis (bone resorption – the reverse process of laying down new bone material)
o periosteal reaction (New bone formation in response to injury)
 cortical thickening
o Leaching of Chromium – Toxicity (all patients were offered nail removal, and 12 nails
were removed. The remaining nails were analysed for any toxicity)
o thigh pain in patients
[1]
• As a result of these findings, the device used was abandoned

Slide 19 – Porous Metallic implants: Material – Cobalt-Chrome Alloys

• Welsh et al was the first to introduce porous cobalt-chromium surfaces, back in 1970
• Cobalt-Chromium offer
o Inertness / biocompatibility
o mechanical durability [1]
• Clinical Experiment, done in1980 using Cobalt- Chromium surfaces
o Cobalt-chromium porous rooted dental implant in dogs
o Solid metal core with a porous coating of 2 mm thick
o 2 pores of different sizes were studied [2]

Slide 20 – Porous Metallic implants: Material – Cobalt-Chrome Alloys

• Successful Implants
o a clinical appearance similar to natural teeth.
 o No bone resorption
o bone was in direct contact to surface of the implant
o No variation between fine and large pores – both showed growth of bone in
pores
o excellent biological response [1]

Slide 21 – Porous Metallic implants: Material – Cobalt-Chrome Alloys

• Implant failures – Two distinct periods of failure were evident:

o an early period
 tissue destruction and inflammation
 bone destruction and resorption
o Late failure
 tissue inflammation
 Failure due to implant mobility
 gross bone loss
• These findings may be of concern as this may hinder the success of long-term
fixation [1]
• Nowadays, CoCr porous coatings are used for
o acetabular cups
o femoral stems
o total knee arthroplasty components [2]

In the early 1970s, Welsh et al. focused on porous cobalt-chromium surfaces due to its
attractive properties of inertness/biocompatibility and mechanical durability (1).
The CoCr beaded porous coatings are applied in acetabular cups, femoral stems and total
knee arthroplasty components.
In a study of 72 hips with a CoCr beaded acetabular cup the incidence of aseptic loosening
was found to be 4% at an average of 8.5 years follow up.
CoCr beaded femoral stems have garnered better clinical success with regards to survival and
fixation. Sakalkale et al. reported 95% stable ingrowth of CoCr beaded stems at an average of
11.4 years.
However ingrowth analysis shows minimal ingrowth and fibrous tissue formation in Co-Cr
bead coated implants and these findings may be of concern as this may hinder the success of
long-term fixation (1).

Slide 22 – Porous Metallic implants: Material – Titanium and Titanium alloys

• Titanium alloys were first used as implants back in the mid-1940s

• Till today, this material continued to gain attention due to it being

o a safe material

o Having the closest elastic modulus when compared to bone

 • Unalloyed Titanium graded is found to be

o mechanically strong

o lighter than steel

o highly resistant to corrosion

• However, as a bone filler material, the strength of pure Ti is not sufficient [1,2]

Slide 23 – Porous Metallic implants: Material – Titanium and Titanium alloys

• Ti alloys are preferred due to their superior mechanical properties

• Titanium alloys were introduced as biomedical implant industry due to

o High specific strength

o light weight

o excellent biocompatibility

o corrosion resistance

• drawback observed with Titanium and its alloys is

o severe frictional wear - leading to wear debris causing inflammatory reactions.

• The two distinct types of porous titanium alloy implants are

o thin plasma sprayed coating

o metal foams [1,2]

Slide 24 – Porous Metallic implants: Material – Titanium and Titanium alloys

• Plasma sprayed Titanium alloy coatings are

o proved to be safe and a predictable material in long-term studies

o But, coating’s porosity ranges from 30-50 % - limiting strength by the formation of
bone ingrowth

o Average in growth of 15-30%

o Thus, cannot be used as bulk structural materials

o Applications include total hip and knee arthroplasty [1,2]

Slide 25 – Porous Metallic implants: Material – Titanium and Titanium alloys

• The titanium alloy metallic foams have

 o Porosity ranging from 60-80%

o Pore sizes from 100-600 µm

o Can be used in bulk form or as a coating

o Resemble mechanical, morphology and structure of bone

 High surface friction properties

 Improved porosity level

 Low modulus of elasticity

• Applications include primary and revision total hip, knee and shoulder arthroplasty, and
dental implants [1,2]