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Cartilex®, a new
method for articular cartilage surgery
Background of the work
Cartilex Method
Development
Stages
of the Cartilex project
Intellectual
Property
The cartilex Laser.
Short Bibliography
Vocabulary
Publication and Video
Cartilex®, a new
method for articular cartilage surgery
Patents UE #
2000108
, USA #
8034091 B2.
Background of the work
Arthritis
Arthritis is not
just a painful condition for people, but it also affects horses and pets.
The pathogenesis of osteoarthritis is
likely multifactorial involving mechanical, biological, biochemical, and genetic
factors [1–4]. These factors can all contribute to progressive degeneration and
loss of articular cartilage. In the earliest stages of cartilage injury and
degeneration, proteolytic breakdown of the extracellular matrix, which is
comprised primarily of collagen type-II and proteoglycans, occurs [2–4]. In
addition, there may also be actual or functional loss of articular chondrocytes.
The remaining healthy chondrocytes attempt to balance the formation and
breakdown of matrix molecules. However, the balance between anabolic and
catabolic processes ultimately exceeds the repair capabilities of the
chondrocytes resulting in matrix destruction, cartilage loss, and eventually,
osteoarthritis [3, 4].
The
toll of arthritis
Horses are elite athletes just like human athletes, and any decline in ability
to perform is not acceptable in many cases. There
are about 60 million domestic horses worldwide. In competition horses
about 10% are suffering joint problems.
In human, approximately one in six
adults aged 15 years and over has arthritis. Nearly three of every five people
with the disease are of working age (under 65). Arthritis ranks second and third
among the most commonly reported chronic conditions in women and men,
respectively. Compared to people with other chronic conditions, a higher
proportion of people with arthritis reports experiencing moderate to severe
pain, restricted activity and long-term disability.
Osteoarthritis (OA) affects over 27
million adults in the United States today, and the prevalence is expected to
increase to 67 million by 2030 [1].
The
economic burden of arthritis
The estimate
economic cost of arthritis are € billion annually in industrial countries.
Long-term disability accounts for almost 80 per cent of arthritis-related costs,
with 70 per cent of these costs incurred by individuals aged 35-64. For
instance, Musculoskeletal diseases accounted for 10.3 per cent of the total
economic burden of all illnesses in Canada in 1998, arthritis alone accounts for
more than 40 per cent of drug expenditures for musculoskeletal diseases in that
same year. [5]
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Our Cartilex method shall substantially reduce the cost of health by
delaying or suppressing the need for arthroplasty and
the toll on economy by decreasing the number of disabled
persons. |
Diagnosis of Early
Arthritis
The pathological changes in osteoarthritis start at the molecular scale and
spread to the higher levels of the architecture of articular cartilage to cause
progressive structural and functional damage. Early
diagnosis and staging of cartilage change include supporting a clinical paradigm
shift from viewing osteoarthritis as an untreatable degenerative condition to
that of a potentially modifiable chronic disease process. [19-20]
Early Treatment
of osteoarthritis
At present, the only
early treatments to cure or
attenuate the early degradation of cartilage is laser resurfacing. Since laser
systems became available for arthroscopic surgery a certain number of clinical
uses have been reported. One of the special applications is the smoothing of the
fibrillated hyaline cartilage, which is not possible by the customary mechanical
or motorized instruments without leaving in place a toothbrush-like surface with
bad mechanical properties and the risk of an enlarged degeneration area. The
actual advantage of a cartilage debridement had only been the elimination of
locking flaps, with the danger of tearing down more of the cartilage by the
shaving procedure [6]. However laser and other resurfacing instruments developed
since have all some drawback [7-15].
The first use of arthroscopy in
European veterinary surgery
occurred in horses, and by the
mid-1980s,arthroscopy in equine surgery was becoming common place.
Today, arthroscopy for the
diagnosis and treatment of equine orthopaedic diseases is well accepted and
routine.
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Cartilex Method
There is a need
to improve currently used chondroplasty techniques, to decrease damaging of
significant amount of healthy cartilage while removing damaged or diseased
tissue in clinical cases of early OA. Pr Pierre Ravussin has developed a new
patented technique called Cartilex® for performing articular
cartilage tissue ablation in joint such as human knee or horse joint.
Partial‑thickness articular cartilage lesions in adults have no propensity to
heal. In the orthopaedic arts, it is known that cartilage has to be reshaped in
order to treat certain joint disorders such as hyaline cartilage surface
irregularities.
Cartilex method
presents a net advantage over mechanical or other techniques for articular
resurfacing. By using Cardiogreen, an injectable medical dye, that attaches to
the cartilage surface and absorbs the laser beam, the Cartilex method allows
removing a controlled volume of damaged hyaline cartilage while suppressing
collateral damage to surrounding healthy cartilage. The energy needed to remove
surface cartilage is 10x less that with conventional Ho:YAG laser. Thus, the
thermally affected zone is very small.
à
Very important: the result is much less operator dependent.
ß
Some preliminary research has
demonstrated that laser energy can stimulate DNA synthesis and matrix production
in articular cartilage. However laser has the potential to cause thermal damage
when used on articular surface. Preliminary data showed that the Cartilex method
(a modified diode laser technique) provides a unique possibility with a thermal
damage depth less than 10
mm. This finding is in
contrast with other chondroplasty techniques like erbium, holmium lasers or
other techniques, where thermal or mechanical damage penetrates up to 500
mm.
[7-15]
à
Therefore the thermal side effects are negligible
ß
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Development
Stages
of the Cartilex project
Preliminary
studies were performed at the Ecole Nationale Vétérinaire d’Alfort (France) and
at the Institute of Pathology of the University of Bern (Switzerland) on bovine,
horse and human hyaline cartilage.
Horse Cartilage
Click
to enlarge
Feasability study, CTI project 9012.2 PFLS-LS.
The feasibility
study of the Cartilex method take place at the Institute of Pathology of Bern
University [16].
The
results have been graded as “Success story”:
Establish
condition for optimal cardiogreen diffusion and penetration in hyaline live
cartilage.
Protocols to
color bovine and human hyaline cartilage have identified the optimal indocyanine
green (ICG) concentration and application of 10mg/ml in PBS for 10 minutes. The
thickness of all coloured cartilage is reproducibly around 10μm, with the
remaining light harmlessly diffusing through the uncoloured cartilage.
Coloured hyaline human
cartilage
Click to enlarge
Establish optimal diode
laser parameters for controlled cartilage removal in vitro.
The experiments testing the optimal diode laser settings revealed that energy
levels should be high (peak energy level of minimum 50W) and combined with short
pulses (<1ms). Importantly, cartilage removal had minimal thermal side effects,
resulting in negligible cell death in the surrounding tissue.
Analyzing
the thermal effect of Cartilex method
with a fluorescence technique.
Fluorescence
Confocal microscope images study
of the live/dead cells staining of cartilage indicates negligible cell death of
the underlying tissue. The surface cartilage removal is thicker than the
coloured layer, ranging from 30μm to 100μm, indicating an energy transfer
process from the laser light absorbing layer to the deeper cartilage.
Furthermore, spectral light measurements have demonstrated that the ICG
coloration of cartilage results in a large band of absorption indicating that
the tolerance of the diode laser wavelength is wide, a feature facilitating
diode laser production.
Live/dead cells
Click to enlarge
Testing
application to clinical circumstances
An ex
vivo pilot study has been performed by the Vetsuisse Faculty of the University
of Bern, on the equine medial femorotibial joint. It has showed, that the
system is applicable in clinical circumstances. A possibility of transferring
observations from an animal model to human condition is an additional very
important aim of this experiment. In a comparative study of articular cartilage
thickness in the stifle of animal species used in human pre-clinical studies,
the horse provided the closest approximation to humans in terms of articular
cartilage thickness. This finding is considered relevant in pre-clinical studies
of cartilage healing [17-18].
Cartilage resurfacing Click
to enlarge
Test on live
horses.
Clinical trial
on live horses can provide us with valuable information about the clinical
usefulness of a potentially better than currently available chondroplasty
methods for treating equine and human first stage osteoarthritis cases.
The
equine models offer advantages as in that the horse gets clinical disease
similar to human, the articular cartilage thickness is comparable, large
multiple defects can be created, the arthroscope can be used to create lesions
and do reexaminations, controlled exercise post-operatively can be done and the
horses can be monitored clinically.
Horses are
elite athletes just like human athletes, and any decline in ability to perform
is not acceptable in many cases. An immediate weight-bearing following operation
can not be avoided in horses. Biomechanical forces working in equine joints can
not be modelled with other species like sheep or rabbit. In a comparative study
the horse hyaline cartilage thickness provided the closest approximation to
human cartilage, which finding is considered relevant in pre-clinical studies of
cartilage healing. [17-18].
The aim of this
study is to evaluate the six to eight months (medium‑term) follow‑up
consequences of the Cartilex technique in an experimentally induced early OA
model.
The live horses
study design has been setup by the Vetsuisse Faculty of the University of
Bern.
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of Page
Intellectual
Property
The Cartilex
method is protected by the UE patent 2000108 and the USA patent
8034091 B2.
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of Page
The cartilex
Laser.
Cartilex® 250
is the surgical diode laser that is used with the Cartilex method. Thanks to the large experience of the developers in
laser technology, all the parts of Cartilex 250 has been optimized to
obtain what we believe to be the best veterinary surgical diode laser of the market
at a reasonable price. Cartilex 250 can be moved from one place to the other
without futher adjustment.
Cartilex
250
has successfully passed the test for the
marking.
Cartilex
Laser Click
to enlarge
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of Page
Bibliography
Bibliography
Publication and Video
Articulary Cartilage (pdf 1,6MB)
Chirurgie
arthroscopique avec Cartilex
(Media player 10MB)
Arthroscopie du genou (non laser) (Media player
3MB)
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