Current Orthopaedics (2000) 14, 7–15

© 2000 Harcourt Publishers Ltd

DOI: 10.1054/ cuor.1999.0074, available online at http://www.idealibrary.com on

Millennium challenge mini-symposium

(ii) The challenge of orthopaedic materials

L.L. Hench

INTRODUCTION patients need prostheses (Fig. 1) and the quality of

During the last century, orthopaedics underwent a
revolution, a shift in emphasis from palliative treat-
ment of infectious diseases of bone to interventional
treatment of chronic age-related ailments. Many
factors were responsible for this revolution: the avail-
ability of antibiotics to control infection, new anaes-
thetics that made surgery safe, the evolution of stable
fixation devices, and the systematic development of
reliable total joint prostheses. The history and the
current practice of these revolutionary steps are well
documented.1–6 and thus will not be repeated here.
Our interest is the role of biomaterials in making
this revolution possible. We must now assess the
status of orthopaedic biomaterials at the end of this
century and decide whether they are sufficient to meet
the needs of orthopaedics for the next.
THE GOAL
bone of the patients progressively deteriorates with
age, especially for women after the menopause
(Fig. 2). The two effects are multiplicative and con-
tribute to the continuing decline in implant surviv-
ability with patient age (Fig. 3).
Thus, the challenge for orthopaedic materials in
the new millennium is twofold: (1) improve implant
survivability by 10 to 20 years; or (2) develop alterna-
tive means of orthopaedic treatment that does not
require implants, or at least delays by 10–20 years the
need for prostheses. The objective of this paper is to
discuss the means of meeting this challenge.
ALTERNATIVES FOR 2000–2020
Two alternative pathways of treatment of patients
with chronic bone and joint defects are now possible
(Fig. 4): (1) transplantation or (2) implantation.

Devices and prostheses made from orthopaedic bio-

materials ideally should survive without failure for
the lifetime of the patient. The challenge is that the
lifetime of patients has progressively increased during
this century (Fig. 1) and will continue to do so for the
next thirty years or so. Average life expectancy is cur-
rently at 80+ years, an increase of more than 10 years
since the 1960s, when Professor Sir John Charnley
pioneered use of low friction arthroplasty. There is a
compound effect of increased patient lifetime on the
survivability of orthopaedic prostheses; many more

Fig. 1 Survivability of the populations of England and Wales in

Professor L.L. Hench, PhD, FSGT, FACerS, FAIMBE, FBSE, the 1880s and 1990s compared with the progressive decrease in
Department of Materials, Imperial College of Science, Technology quality of bone (strength and density) for people of the same age.
and Medicine, Prince Consort Road, London SW7 2BP, UK. Tel: Survivability data from Tom Kirkwood’s book Time of our Lives,
0171 594 6745; fax: 0171 594 6809; E-mail 1.hench@ic.ac.uk Weidenfeld and Nicholson, 1999.

7
8 Current Orthopaedics
Fig. 2 Effect of age on strength of bone for men and women.
Harvesting the patient’s tissue from a donor site and
transplanting it to a host site, at times even maintain-
ing blood supply, has become the ‘gold standard’ for
many surgical procedures such as vertebral fusion and
revision surgery.
This type of tissue graft, called an autograft, raises
minimal ethical or immunological concerns but does
have important limitations, especially limited avail-
ability, second site morbidity, tendency towards
resorption, and sometimes a compromise in biome-
chanical properties. A partial solution to some of
these limitations is use of transplant tissue from a
human donor, a homograft, either as a living trans-
plant (heart, heart–lung, kidney, liver, retina) or from
cadavers (freeze-dried bone). Availability, requirement
for immunosuppressant drugs, concern for viral or
prion contamination, ethical and religious concerns
all limit the use of homografts.
Transplants, both living and non-living, from other
species, called heterografts or xenografts, provide a
third option for tissue replacement (Fig. 4). Non-
living, chemically treated xenografts are routinely
used as heart valve replacements (porcine) but bovine
bone substitutes have gradually been abandoned. Use
of genetically modified living heterografts is contro-
versial and seldom used at present.
Fig. 4 Alternative means of repairing orthopaedic defects: Past, Present and Future.
Fig. 3 Survivability of total hip prostheses. Data from
reference 3.
The second line of attack in the revolution to
replace tissues (Fig. 4) was the development, or in
many cases modification, of man-made materials to
interface with living, host tissues, e.g. implants made
from biomaterials. The important advantages of
implants over transplants are availability, repro-
ducibility and reliability. Good manufacturing prac-
tice, international standards, government regulations
and quality assurance testing minimize the probability
of mechanical failure of implants. However, most
implants in use today continue to suffer from prob-
lems of interfacial stability with host tissues, biome-
chanical mismatch of elastic moduli, production of
wear debris and maintenance of a stable blood supply.
In addition, all present day orthopaedic implants lack
two of the most critical characteristics of living tis-
sues: (1) ability to self-repair; and (2) ability to modify
 The challenge of orthopaedic materials 9

Table 1 Composition, bioactivity and mechanical properties of bioactive ceramics used clinically†

Sintered
hydroxyapatite Sintered
Bioglass Glass-ceramic Glass-ceramic Glass-ceramic Glass- ceramic Ca10(PO4)6(OH)2 β-3CaO.P2O5
Property 45S5 S45PZ Ceravital Cerabone A/W Ilmaplant L1 Bioverit (>99.2%) (>99.7%)

Composition (wt%)
Na2O 24.5 24 5–10 0 4.6 3–8
K2O 0 0.5–3.0 0 0.2 3–8
MgO 0 2.5–5.0 4.6 2.8 2–21
CaO 24.5 22 30–35 44.7 31.9 10–34
Al2O3 0 0 0 0 8–15
SiO2 45.0 45 40–50 34.0 44.3 19–54
P2O5 6.0 7 10–50 16.2 11.2 2–10
CaF2 0 0.5 5.0 3–23
B2O3 0 2

Phase‡ Glass Glass Apatite Apatite Apatite Apatite Apatite Whitlockite

Glass β-Wollastonite β-Wollastonite Phlogopite
Glass Glass Glass

Index of
Bioactivity*
IB 12.5 12 5.6 6.0 NA NA 3.1 NA
Class of A A B B NA NA B NA
Bioactivity
Bone Bonding Yes Yes Yes Yes NA NA Yes NA
Soft Tissue
Bonding Yes Yes No No NA NA No NA
Density (g/cm3) 2.6572 3.07 2.8 3.16 3.07
Vickers hardness (HV) 458 ± 9.4 680 500 600
Compressive 500 1080 500 500–1000 460–687
strength (MPa)
Bending 42§ 215 160 100–160 115–200 140–154
strength (MPa)
Young’s 35 100–150 218 70–88 80–110 33–90
modulus (GPa)
Fracture toughness, 2.0 2.5 0.5–1.0 1.0
KIC (MPa.m1/2)
Slow crack growth, n 33 12–27
(unitless)

‡Apatite is Ca10(PO4)6(O,F), β-wollastonite is CaO.SiO2, phlogopite is (Na,K)Mg3, (AlSiO10)F2, and whitlockite is β-3CaO.P2O5. §Tensile.
*Index of bioactivity of implant materials (IB = 100/t0.5, where t 0.5 is the time for 50% of the interface to be bonded to bone)

their structure and properties in response to environ-
mental factors such as mechanical load.
The consequences of the above-cited limitations
are profound. All implants have limited lifetimes3, as
illustrated in Figure 3. Many years of research and
development have led to only marginal improvements
in the survivability of orthopaedic implants at more
than 15 years. For example, efforts to improve life-
times of orthopaedic prostheses through morphologi-
cal fixation (large surface areas or fenestrations) or by
biological fixation (porous ingrowth) have not
improved survivability over cement fixation of
prostheses.
THE BIOACTIVE ALTERNATIVE
During the last decade considerable attention has
been directed towards use of bioactive fixation of
implants, where bioactive fixation is defined as inter-
facial bonding of an implant to tissue by means of
formation of a biologically active hydroxyapatite layer
on the implant surface,1,4,7
An important advantage of bioactive fixation is
that a bioactive bond to bone has strength equal to or
greater than bone after 3–6 months. The high strength
of both hard and soft tissue bonding to bioactive
implants is due to in vivo growth of a dense layer of
nanometer-scale hydroxy-carbonate apatite (HCA)
crystal agglomerates, which bind to collagen fibrils.
The physical chemical mechanisms involved in form-
ing a bioactive bond to tissues are now well estab-
lished (reaction stages 1–5 in Fig. 5).7 Knowledge of
the sequence of cellular events associated with form-
ing a bioactive bond to bone are also documented
(reaction stages 6–11 in Fig. 5). Details at a molecular
biological and genetic level are currently being estab-
lished. Comparative studies of various compositions
of bioactive glasses, ceramics and glass-ceramics show
that there is a considerable range of levels of bioactiv-
ity, as measured by rates of bone bonding to bulk
implants or rate of bone proliferation in the presence
of bioactive particulates. A very limited range of
bioactive glass compositions, containing SiO2-Na2-
CaO-P2O5, that have less than 55% SiO2 exhibit a high
bioactivity index (Table 1) and bond to both bone and
10 Current Orthopaedics
Fig. 5 Sequence of interfacial reactions involved in forming a
bond between bone and bioactive glasses.
soft connective tissues1,4,7. This range of materials has
been designated to exhibit Class A bioactivity.7
An important feature of Class A bioactive particu-
lates is that they are osteoproductive as well as osteo-
conductive. In contrast, Class B bioactive materials
exhibit only osteoconductivity, defined as the charac-
teristic of bone growth and bonding along a surface.
As indicated in Table 1, dense synthetic hydroxyap-
atite (HA) ceramic implants exhibit Class B bioactiv-
ity. Osteoproduction occurs when bone proliferates on
the particulate surfaces of a mass due to enhanced
osteoblast activity. Enhanced proliferation and differ-
entiation of osteoprogenitor cells, stimulated by slow
resorption of the Class A bioactive particles, are
responsible for osteoproduction.
During the last decade, it has often been assumed
that the improved interfacial stability achieved with
bioactive fixation would improve implant survivabil-
ity. Clinical trials have shown this to be a false
assumption. Replacement of the roots of extracted
teeth with dense HA ceramic cones to preserve the
edentulous alveolar ridge of denture wearers resulted
in generally less than 50% survivability at only five
years3. Very few clinical trials of HA-coated
orthopaedic implants have been reported to date with
surviabilities at 10 years greater than the 85% figure
for cemented total hip prostheses.3 However, long-
term success rates of bioactive HA coatings may
improve during the next decade due to greater control
of the coating process.
Why is bioactive fixation not a panacea to implant
survivability? There are three primary reasons: (1)
metallic prostheses with a bioactive coating still have a
mismatch in mechanical properties with host bone,
and therefore less than optimal biomechanical and
bioelectric stimuli, at the bonded interface, (2) the
bioactive bonded interface is unable to remodel in
response to applied load, and (3) use of bioactive
materials does not solve the problem of osteolysis due
to wear debris.
These factors are a natural consequence of the lim-
itations of all non-living implants discussed above.
Solving one problem, i.e. interfacial stability, does not
solve the others. The negative consequence of biome-
chanical mismatch is compounded by numerous other
factors when bulk bioactive implants or coated load
bearing implants are placed in function. The host tis-
sue is often of poor quality (Fig. 2) and circulation
and metabolism are often compromised by disease,
ageing, or pharmaceutical therapies. A further com-
plication is that biomechanical designs of prostheses
are seldom optimized to ensure that loads are prop-
erly distributed to the bone when the interface has a
bioactive bond.
Most biomaterials in use today and the prostheses
made from the materials have evolved from trial and
error experiments.2,5 It is little wonder that optimal
biochemical and biomechanical features have not
been achieved and it also is not surprising that long-
term implant survivability has not been improved very
much.
THE BIOCOMPOSITES ALTERNATIVE
Biocomposites are being developed to eliminate the
problem of elastic modulus mismatch and stress
shielding of bone.1,2,8–10 Two approaches have been
tried. Bioinert composites, such as carbon–carbon
fibre composite materials, are routinely used in
aerospace and automotive applications. These
lightweight, strong and low modulus materials would
seem to offer great potential for load-bearing
orthopaedic devices.8,9 However, delamination can
occur under cyclic loading which releases carbon
fibres into the interfacial tissues. The carbon fibres
give rise to a chronic inflammatory response. Thus,
bioinert composites are not widely used and are
unlikely to be a fruitful direction for development in
the next century.
The second approach is to make a bioactive com-
posite that does not degrade.1,2,10 The composite pro-
cessing stiffens a compliant biocompatible synthetic
polymer, such as polyethylene, with a higher modulus
bioactive ceramic second phase, such as synthetic HA
or bioactive glass (BG).10 The result is a material that
has an elastic modulus that is much closer to that of
bone and will produce a bioactive bond to bone when
implanted. An important advantage of this concept is
that the mechanical properties of strength and elastic
modulus can be controlled, within limits, by varying
the volume fraction, size and distribution of the sec-
ond phase. Ideally, it is possible to match the proper-
ties of both cancellous and cortical bone, although, as
shown in Figure 6, this is seldom achieved by the bio-
composites available today.9 A challenge for the next
decade is to use advanced materials processing tech-
nology to improve the interfacial bonding between the
phases and thereby increase strength and fracture
toughness of these new materials.10

Fig. 6 Strength and elastic modulus of composites compared with bone. (Reproduced from Thompson & Hench 1998 with permission)
Another option is to use a resorbable polymer matrix
for a biocomposite that will be replaced with mineralis-
ing bone as the load on the device is increased.8,9 Work
in this area is in progress but it is difficult to maintain
structural integrity as resorption occurs. The tissue engi-
neering alternative is based upon this concept.
A NEW REVOLUTION IN ORTHOPAEDICS?
Perhaps it is time to accept that the orthopaedics rev-
olution of the last 30 years, the revolution of replace-
ment of tissues by transplants and implants, has run
its course. It has led to a remarkable increase in the
quality of life for millions of patients; total joint pros-
theses provide excellent performance and survivability
for 10–15 years. Prostheses will still be the treatment
of choice for many years to come for patients of 70
years or older. However, continuing the same
approach of the last century; i.e. modification of
implant materials and designs, is not likely to reach
our goal of 25–30 years’ implant survivability, an
increasing need of our ageing population (Fig. 1). We
need a change in emphasis in orthopaedic materials
research; in fact, we need a new revolution.
THE FUTURE: REGENERATION OF TISSUES
The challenge for the next millennium: ‘I propose that
we need to shift the emphasis of biomaterials research
towards assisting or enhancing the body’s own repara-
tive capacity’.
Our working hypothesis should be: ‘Long-term
survivability of prostheses will be increased by the use
of biomaterials that enhance the regeneration of natu-
ral tissues’.
Our goal of regeneration of tissues should encom-
pass the following:
The challenge of orthopaedic materials 11
• restoration of metabolic and biochemical
behaviour at the defect site, which leads to:
• restoration of biomechanical performance, by
means of:
• restoration of structure, which leads to our
objective:
• restoration of physiological function.
The concept requires that we develop biomaterials
that behave in a manner equivalent to an autograft, i.e.
a regenerative allograft. This is a great challenge.
However, the time is ripe for such a revolution in think-
ing and priorities. Enormous advances have been made
in developmental biology, genetic engineering, cellular
and tissue engineering, imaging and diagnosis, and
micro-optical and micromechanical surgery and repair.
Molecular control of the texture of hierarchical
bioactive materials over six orders of magnitude, from
scales of nanometers to millimetres, is now possible
using a new generation of low-temperature chemical
sol-gel processing of materials.11–14 Self-assembled
biomolecular structures are feasible.15 Microporous
and meso-porous inorganic and hybrid
inorganic–organic matrices and scaffolds can be pro-
duced with controlled rates of resorption and con-
trolled surface chemistries with isoelectric points
ranging from pH = 5–8, thereby matching the electro-
chemical changes that occur during the repair of bone
by natural means. Not only can the rates of resorption
be controlled in such materials but the type and con-
centration of inorganic or organic species and their
sequence of release can be varied, a vital requirement
in stimulating cell proliferation or enhancing cell dif-
ferentiation following proliferation.7 As the develop-
mental and molecular biologists discover the genes
involved in phenotype expression and bone and joint
morphogenesis, we will learn the correct combination
of extracellular and intracellular chemical concentra-
tion gradients, cellular attachment complexes and
12 Current Orthopaedics
other stimuli required to activate tissue regeneration
in situ. Progress has already been made in understand-
ing the role of protein templates in biomineraliza-
tion.15 Recent studies to be reported at the Second
Annual Meeting of the British Cell and Tissue
Engineering Society, July 2000, will reveal the genes
that are up-regulated and down-regulated by bioactive
glass extracts during proliferation and differentiation
of primary human osteoblasts in vitro. These findings
should make it possible to design a new generation of
bioactive materials for regeneration of bone.
BIOACTIVE GEL-GLASSES: A REGENERATIVE
MATERIAL?
The biological response to bioactive gel-glasses made
from the CaO-P2O5-SiO2 system provide recent evi-
dence that bone regeneration is feasible. Low-temper-
ature hydrolysis and condensation reactions of
tetraethoxysilane (TEOS) and calcium and phospho-
rous alkoxide precursors create a highly intercon-
nected 3-D gel network composed of (SiO4)4-
tetrahedra bonded either to neighbouring silica tetra-
hedra via bridging oxygen (BO) bonds or by Si-O-Ca
or Si-O-P non-bridging (NBO) bonds.13,16–18 The 1–10
nm scale solid network that comprises the gel is com-
pletely interpenetrated by pore liquid. The pore liquid
consists of a highly structured hydrated layer that has
substantially different physical chemical properties
than free water and is more like the bound water con-
tained within highly hydrated connective tissues such
as cartilage. Biological molecules can exchange with
these hydrated layers inside the pores of gel-glasses
and maintain their conformation and biological activ-
ity7,11,14,15. Many enzymes remain active within a
hydrated gel matrix, and in some cases exhibit
enhanced activity. Such hierarchical structures and
behaviour go far beyond historically important bioin-
ert orthopaedic materials such as PMMA, ultrahigh
molecular weight polyethylene, stainless steel, Co-Cr
and Ti-alloys towards matching the ultrastructure and
molecular chemistry of bone.
An important factor for future research is that the
structure and chemistry of bioactive gel-glasses can be
tailored at a molecular level by varying either compo-
sition (such as SiO2 content) or thermal or environ-
mental processing history. The compositional range
Table 2 Composition and BET data of stabilized bioactive gel-glasses vs 45S5 melt-derived glass
Sample SiO2 P2O5 CaO
(mol%) (mol%) (mol%)
49S gel-glass 50 4 46
58S ′′ ′′ 60 4 36
68S ′′ ′′ 70 4 26
77S ′′ ′′ 80 4 16
86S ′′ ′′ 90 4 6
45S5 glass 46.1 2.6 26.9
Fig. 7 Compositional range of bioacive gel-glasses compared
with melt-derived glasses.
for Class A bioactive behaviour is considerably
extended for the bioactive gel-glasses over Class A
bioactive glasses and glass-ceramics made by standard
high-temperature melting or hot pressing7 (Fig. 7).
Thus, gel-glasses offer several new degrees of freedom
over the influence of cellular differentiation and tissue
proliferation.7,17–19 This enhanced biomolecular con-
trol will be vital in developing the matrices and scaf-
folds for engineering of tissues and for the in vivo
regenerative allograft stimulation of tissue repair
(Fig. 3).
Evidence of the regenerative capacity of bioactive
gel-glasses (see Table 2 for compositions) is based on
comparison of the rates of proliferation of trabecular
bone in a rabbit femoral defect model.20 Melt-derived
Class A 45S5 bioactive glass particles exhibit substan-
tially greater rates of trabecular bone growth and a
greater final quantity of bone than do Class B syn-
thetic HA ceramic or bioactive glass-ceramic particles
(Fig. 8). The restored trabecular bone has a morpho-
logical structure equivalent to the normal host bone
after 6 weeks (Fig. 9); however, the regenerated bone
still contains some of the larger (> 90 micrometers)
bioactive glass particles.20,21
Recent studies show that use of bioactive gel-glass
particles in the same animal model produces an even
faster rate of trabecular bone regeneration with no
residual gel-glass particles of either the 58S or 77S
composition.21 The gel-glass particles resorb more
rapidly during proliferation of trabecular bone. The
Na2O Surface area Pore volume Average pore size
(mol%) (m2/g) (cm3/g) (nm)
0 203 0.57 5.7
0 289 0.49 3.4
0 326 0.41 2.5
0 431 0.32 1.5
0 627 0.45 1.4
24.4

Fig. 8 Quantitative comparison of percentage of bone growth
into bone defects from 1 to 24 weeks due to 45S5 Bioglasss, A/W
glass-ceramic and sintered HA particles of 100–300 um size.
mechanical quality of the regenerated bone appears
to be equivalent to that of the control sites.22 Thus, the
criteria of a regenerative allograft cited above appear
to have been met. Our challenge for the future is to
extend these findings to studies in compromised
bones, with osteopenia and osteoporosis, to apply the
concept to humans with ageing bones and degenera-
tive joint disease and to use the results to design the
3-D architectures required for engineering of tissues.
ORTHOPAEDIC CLINICAL USE OF
REGENERATIVE BIOACTIVE MATERIALS
Clinical application of the use of a regenerative bio-
material in orthopaedics is beginning. In 1993, partic-
ulate bioactive glass, 45S5 Bioglass was cleared in the
USA for clinical use as a bone graft material for the
repair of periodontal osseous defects. Since that time,
numerous oral and maxillofacial clinical studies have
been conducted to expand the material indication.
More than 400 000 reconstructive surgeries in the jaw
have been performed with the material.
The same material has been used by several
orthopaedic surgeons to fill a variety of osseous
defects. The use of 45S5 bioactive glass particles in
four such orthopaedic applications is summarized
below:23
A. In 1994, the short-term experience with Bioglass®
in ten patients during hip and knee arthroplasty
was reported. Bioglass® particulate was mixed
The challenge of orthopaedic materials 13
Fig. 9 Regenerated trabecular rabbit bone forms as early as one
week in contact with 45S5 Bioglass particulates.
with freeze-dried allograft as a bone graft extender
and applied via impaction grafting. Clinical and
radiographic results were compared to controls
that did not receive Bioglass®. No differences in
healing were observed between the test and control
groups. Using standard clinical rating systems, all
hips and knees were rated as either good or
excellent, with no infections being noted.
Radiographic analysis of the grafted sites
appeared normal, with no osteolysis or periosteal
reactions detected.
B. Bioglass® particulate also has been mixed with
autogenous bone for impaction grafting during
primary hip and knee arthroplasty. A review of
14 patients from one surgeon indicated use around
total knee components, and around both the
femoral and acetabular components for hip
arthroplasty.
Case report
A 72-year-old female presented with severe degenera-
tive arthritis of the left hip, the right hip having a pre-
vious total hip replacement. After preparation of the
hip, the acetabular component was coated with a layer
of autogenous bone mixed with Bioglass® and was
impacted into position. The same autograft-Bioglass
mixture was impacted into the reamed femoral cavity.
The femoral component was seated and the surgical
site was reduced and closed. At six weeks, the patient
was without pain and had a full range of motion. At
14 Current Orthopaedics
8- and 15-month follow up visits, the patient was still
pain-free and had a full range of motion.
C. In addition to arthroplasty, bioactive glass
particulate (45S5 Bioglass) has been used in
support of spinal fusion procedures. In a pilot
study involving two patients, clinicians conducted
spinal fusion procedures using autogenous bone
on one side of the spine and a 75:25 mixture on
Bioglass® and autograft on the other. The patients
were evaluated radiographically and clinical
parameters were collected via standardized
functional questionnaires. These case studies are
summarized below:
1. A 73-year-old male complaining of low back and
bilateral leg pain presented with degenerative
spondylolisthesis with stenosis at L4–L5. The
patient as operated on and fusion was achieved
using the appropriate graft materials augmented
by pedicle screws. At 2 weeks, the patient reported
a reduction in pain and by three months, there was
relief from the low back pain with some residual
pain in the left leg. At one year, the back was
significantly improved although there was still
some residual left leg pain. Radiographs of the
spine indicated that the fusion was stable with the
fixation being intact.
2. A 62-year-old male presented with severe spinal
stenosis from L3 to L5 with a history of low back
pain and osteoarthritis. A lifting injury sustained
the previous year had resulted in an acute increase
in back and leg pain, preventing the subject from
working and all but minimal ambulation. A three-
level fusion from L2–L5 was performed using the
autograft and regenerative allograft materials
augmented by screws, rods, and hooks. At 2 weeks,
the patient reported that the acute leg pain had
been relieved. By five months, the subject reported
no leg pain and the back pain had been reduced to
a level that permitted the patient to return to
work. Radiographic analysis revealed a solid
fusion at five months.
D. Based on the results from the above studies, a
controlled clinical trial was initiated in July 1998
to further analyse Bioglass® application in spinal
fusions.26 Ten patients requiring either one- or
two-level fusions were implanted with a 50:50
Bioglass®/autogenous bone mixture on one side of
the spine, the contralateral side receiving autograft
alone. Patients are being evaluated using the
Oswetry Functional Disability Index and a visual
analogue pain scoring system. Success of fusion
on either side is determined via radiographic
analysis and with Dual energy X-ray
absorptometry. No complications have been seen
to date, with implantation times ranging from four
to fourteen months.
Of the 34 patients covered by the above reviews, no
complications have been associated with the use of the
Bioglass® as a graft material. This is in keeping with
the lack of complications seen in oral and maxillofa-
cial applications of these materials. Further clinical
studies are in development for use in additional
orthopaedic indications.
CONCLUSIONS
During the last century, a revolution in orthopaedics
occurred which has led to a remarkably improved
quality of life for millions of aged patients. Specially
developed biomaterials were a critical component of
this revolution. However, high rates of survivability of
prostheses appear to be limited to approximately 20
years. Thus, it is concluded that a shift in emphasis
from replacement of tissues to a new concept of
regeneration of tissues should be the challenge for
orthopaedic materials in the new millennium. The
emphasis should be on use of materials to activate the
body’s own repair mechanisms, i.e. regenerative allo-
grafts. This concept will combine the understanding
of osteogenesis and chondrogenesis at a molecular
biological level with the molecular design of a new
generation of bioactive materials that stimulate prolif-
eration and differentiation of osteoprogenitor cells
and enhance rapid formation of extracellular matrix.
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