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Arthrex Autocart

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299 views20 pages

Arthrex Autocart

Uploaded by

ruiduart
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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AutoCart™

All Autologous Cartilage Regeneration


Table of Contents
Scientific Background.............................................................................. 05
The Healing Triad...................................................................................... 06

Shaver Blades............................................................................................ 08

GraftNet™..................................................................................................... 09

Arthrex ACP® Double Syringe............................................................... 10

Thrombinator™ System............................................................................. 11

User Instructions....................................................................................... 12

Quick Guide to Procedure...................................................................... 18

Ordering Information................................................................................ 19

References.................................................................................................. 19

Table of Contents I 03
Scientific Background

1983
As long ago as 1983, Albrecht et al.1 were able to show that in an animal model, osteochondral lesions filled
with chondral fragments and fastened with specially made fibrin, led to rapid proliferation of chondrocytes and,
ultimately, to the development of hyaline cartilage.

2006
In other preclinical testing in 2006, Lu et al.2 reported the formation of hyaline cartilage in full thickness
lesions after introducing chondral fragments on a bioabsorbable carrier.

A publication by Stone et al.3 in 2006 described the successful treatment of 125 patients with grade IV
cartilage damage, according to the Outerbridge classification, using an articular cartilage paste with the
conclusion: “Paste grafting is a low-cost, 1-stage arthroscopic treatment for patients with Outerbridge
classification grade IV arthritic chondral lesions. The procedure offers excellent, long-lasting pain relief,
restored function, and potential tissue regeneration for patients with painful chondral lesions in both arthritic
and traumatically injured knees.”

2015
In 2015, Christensen et al.4 reported successfully treating 8 patients with osteochondral lesions using a
combination of autologous bone and cartilage fragments and concluded: “Treatment of OCD using autologous
dual-tissue transplantation (ADTT) resulted in very good subchondral bone restoration and good cartilage
repair. Significant improvements in patient-reported outcome was found 1 year postoperative. This study
suggests ADTT as a promising, low-cost treatment option for osteochondral injuries.”

2019
In 2019, Massen et al.5 published a study describing the successful treatment of 27 patients with chondral
and osteochondral lesions, with the conclusion: “Overall, the findings of this study demonstrated that patients
undergoing a single-step autologous minced cartilage procedure had a satisfactory outcome at 2-year
follow-up. As a result, the single-step autologous minced cartilage procedure does represent a possible
alternative to standard autologous chondrocyte implantation.”

Scientific Background I 05
Growth Factors

The Healing Triad

Matrix Regenerative Cells

The Healing Triad

Successful tissue formation requires 3 main components: A scaffold, growth factors, and regenerative cells.
These components form the so-called “healing triad.” A scaffold is needed to provide a structure for tissue growth.
It assures mechanical integrity and provides a substrate for cell growth. Growth factors are bioactive signaling
molecules. They induce differentiation, proliferation, and metabolic activity, and determine the phenotype of the
cells. Regenerative cells, such as vital chondrocytes, also stimulate tissue regeneration.

In the case of cartilage regeneration, the Healing Triad describes the combined use of vital chondrocytes
(regenerative cells), platelet-rich plasma (growth factors), extracellular chondral fragments, and an autologous
thrombin solution (scaffolds).

Material Originating Only From the Patient

Starting with the techniques successfully carried out in the literature, the procedure was further developed,
simplified, and standardized.1 - 5

By using the products listed below, only material from the actual patient is used, so there is no need for a
synthetic carrier.

06 I The Healing Triad


Shaver Blades GraftNet™
Harvesting chondrocytes and Autologous cartilage
autologous cartilage tissue tissue collector

AutoCart™
All autologous
cartilage
regeneration

Arthrex ACP® Thrombinator™ System


(Autologous Conditioned Plasma) For the preparation of
For the preparation of autologous thrombin serum
growth factors

The Healing Triad I 07


ee lesions
lesions involves
involves filling
filling the
the defect
defect site
site with
with particulate
particulate cartilage
cartilage suspended
suspended inin an
an autologous
autologous
ibrin
brin glue.
glue. Particulate
Particulate cartilage
cartilage is
is generated
generated by by collecting
collecting tissue
tissue from
from the
the defect
defect margins
margins and
and
aver.
aver. Autologous
Autologous particulate
particulate cartilage
cartilage is
is advantageous
advantageous because
because itit contains
contains live
live chondrocytes
chondrocytes
widely
widely in
in the
the particle
particle size
size they
they generate
generate and
and level
level of
of aggression
aggression with
with respect
respect to
to tip design111.. ItIt
tip design
long-termShaver
long-term viability
viability ofBlades
of the
the cartilage
cartilage particulate
particulate and
and the
the ability
ability of
of the
the autograft
autograft to to remodel.
remodel.
ty
yy of
of cartilage
cartilage particulate
particulate generated
generated byby different
different shavers
shavers and
and the
the performance
performance of of particulate
particulate

uired
uired within
within 24 24 hours
hours of of slaughter
slaughter and and dissected
dissected to to expose
expose cartilage
cartilage at at the
the patellofemoral
patellofemoral
e was
was collected
collected fromfrom each each location
location as as aa control.
control. Five
Five different
different shavers
shavers (Fig.
(Fig. 1A, 1A, BoneCutter
BoneCutter
3,
3, and
and Excalibur
Excalibur 4mm=E4,4mm=E4, Arthrex)
Arthrex) werewere evaluated
evaluated with with two
two shavers
shavers randomly
randomly assigned
assigned toto
hee shaver
shaver during
during harvest
harvest and and the
the GraftNet®
GraftNet® device device (Arthrex)
(Arthrex) waswas used
used to to collect
collect particulate
particulate
CGM).
CGM). Fluorescent
Fluorescent images images of of DTAF-stained
DTAF-stained particlesparticles werewere collected
collected andand processed
processed in in ImageJ
ImageJ
ticles
icles
icles and
and control
control tissue
tissue was
was assessed
assessed at at 24
24 hr,
hr, 44 and
and 77 days
days after
after collection.
collection. Particles
Particles were
were
ee
ee images Introduction
images were
were acquired
acquired from from random
random locations
locations across
across thethe samples.
samples. LiveLive andand dead
dead cells
cells were
were
A 3 mm Sabre shaver blade or a 4 mm bone cutter shaver blade is used to harvest autologous chondral fragments.
control
ontrol tissue
tissue for
for the
the 24hr
24hr time
time point,
point, while
while viability
viability assessed
assessed atat 44 and
and 77 days
days was was normalized
normalized
Cartilage is harvested either from the edge of the lesion or from a non-loadbearing area. Using these shaver blades
At
At 24hr,
24hr, bovine
bovine
producesblood
blood (Lampire)
fragments(Lampire) was
was
approximately processed
processed
1 mm in
inmaintaining
across, while the
the Angel®
Angel® system
system to
good chondrocyte tovitality.
isolate
isolate platelet
platelet poor
poor 3

hrombin.
rombin. Subsequently,
Subsequently, particlesparticles were
were combined
combined with with these
these blood
blood products
products in in aa 2:1:1
2:1:1 ratio
ratio
⌀x6mm)
x6mm)
x6mm) in inArthroscopic
which
which the the particles
particles
Shaver were
were
Blades with embedded
embedded
Cartilage in
Fragmentsin aa fibrin
fibrin matrix.
matrix. Constructs
Constructs were were cultured
cultured in
in6

nd
d presence
presence of of cell
cell migration
migration (n=2/shaver).
(n=2/shaver). Kruskal-Wallis
Kruskal-Wallis non-parametric
non-parametric tests tests and
and Dunn’s
Dunn’s
nn viability
viability and
and particle
particle sizesize among
among shavers
shavers (=0.05).
(=0.05).

3000 μm 3000 μm 3000 μm 3000 μm 3000 μm

Bone cutter, 4 mm Sabre, 4 mm Torpedo, 4 mm Sabre, 3 mm Excalibur, 4 mm

Particle Size 24-hour Viability 4-Day Viability 7-Day Viability


2.0 3.0
10 a a a, b b c
(%, Normalized to Control)

Fold Change in Viability


Fold Change in Viability

100 2.5
(Relative to 24hr)
(Relative to 24hr)

1 1.5
Area (mm2)

2.0
Viability

0.1
50 1.5
1.0
0.01 1.0

0.001 0 0.5 0.5


BC4 S4 T4 S3 E4 BC4 S4 T4 S3 E4 BC4 S4 T4 S3 E4 BC4 S4 T4 S3 E4
Shaver Shaver Shaver Shaver

25 - 75 % Median Diagrams, Mean ± SD, n = 2 - 3:


Lifetime (24 hours, 4 and 7 days) of the chondrocytes in the cartilage particles harvested using the shaver blade.6
5 - 95 % Mean

Box and whisker diagram, n = 2 - 3:


particle size distribution (area, mm²,
log scale) for various shaver blades6

08 I Shaver Blades
GraftNet™
Autologous Cartilage Tissue Collector

Introduction
The GraftNet system is connected to a suction device to collect autologous tissue for a variety of applications.
The GraftNet tissue collector is mounted between the shaver handpiece and the tubing system. The autologous
chondral fragments obtained are collected in an easily accessible, sterile filter chamber. The tissue collector is
opened and the filter chamber is removed together with the chondral fragments.

Features and Benefits


■ Universal adapters make for easy assembly

■ Autologous bone or cartilage fragments can be harvested


■ Quick access to the harvested tissue
■ Control over the particle size when using a shaver blade system

GraftNet I 09
Arthrex ACP® Double Syringe

Introduction
The Arthrex ACP double syringe is used for the preparation of platelet-rich plasma and the associated concentrated
growth factors.

How It Works
Platelets are activated outside the bloodstream and release proliferative and morphogenic proteins.
These proteins appear to work in synergy to produce the following positive effects:7 - 9
■ Induce proliferation and differentiation of various cell types (such as progenitor cells, osteoblasts,
and epidermal cells)
■ Enhance / modulate production of collagen, proteoglycan, and tissue inhibitors of metalloproteinases (TIMP)
■ Stimulate angiogenesis and chemotaxis

Features and Benefits of the Arthrex ACP® Double Syringe


■ 2-in-1 – unique system for preparation of ACP
■ ACP preparation and use takes just minutes using the Arthrex ACP double syringe
■ The Arthrex ACP double syringe is a sealed, sterile system for use in the doctor’s office and the operating room
■ The system is simple, practical, and safe to use

10 I Arthrex PRP Systems


Thrombinator™ System
An Autologous Thrombin Solution

Introduction
The Thrombinator system for use with the Arthrex ACP double syringe is designed to obtain an autologous
thrombin solution directly at the point of care. Autologous thrombin solution improves handling and fixation by
causing platelets to form a gel that serves as a binding agent for cartilage graft material.

The Thrombinator process uses the blood-clotting cascade mechanism to produce an autologous thrombin
solution and avoids the use of aggressive chemical reagents such as ethanol. The design of the Thrombinator
eliminates the need for prolonged incubation times and heating. An autologous thrombin solution can be
produced from platelet-rich plasma at the point of care in as little as 10 minutes.

Features and Benefits Indications


■ Rapid preparation: 10 - 15 minutes The Thrombinator system for use with the Arthrex
double syringe is designed for the production of an
■ Preparation from whole-blood (WB)
autologous thrombin solution from whole-blood,
platelet-rich plasma (PRP)
platelet-rich plasma.
■ Produces clotting in as little as 15 seconds
■ Centrifugation not required
■ Heating step not required

Thrombinator System I 11
User Instructions
Preparation of ACP

Option Using Arthrex ACP® Double Syringe*

1 2

Draw 15 ml of venous blood using 3 Arthrex ACP Centrifuge at 1 500 rpm for 5 minutes.
double syringes. Then seal the double syringes using
the red caps.

3 4

Carefully decant the ACP supernatant into the small Unscrew the 3 small syringes from the large syringes
syringe. and transfer the ACP obtained into a sterile container
in the sterile area.

*See ACP instructions for more information

12 I User Instructions
Preparation of Autologous Thrombin Solution

1 2

Pour 3 ml of ACP into the Thrombinator system via the Mix for 5 seconds.
port labeled “Inject.”

3 4

Lay down flat and wait 10 - 15 minutes. Shake the system to break up the clot.

5 6

Pour 6 ml of ACP into the Thrombinator system via the Place filter over port labeled “Withdraw” and shake the
port labeled “Inject.” system for 5 seconds.

User Instructions I 13
7 8

Lay down flat and wait 1 minute. Shake the system to break up the clot.

9 10

Turn upside down and withdraw autologous thrombin The thrombin solution is now ready for use.
solution out through the filter over the port.

14 I User Instructions
Cartilage Treatment

1 2

Debride and prepare the cartilage defect as appropriate. Mount the GraftNet tissue collector between the shaver
Take care to create steep edges. handpiece and tubing system.

3 4

Option 1: The harvested chondral fragments are collected in the


Harvest chondral fragments from around the lesion tissue collector.
edges.

5 6

Separate the tissue collector from the handpiece and Transfer the harvested chondral fragments into a 1 ml
tubing system. Open the collector and carefully take syringe with Luer lock connection. Filling from behind
out the filter chamber. is recommended.

User Instructions I 15
7

Using the plunger, push the chondral fragments forward.

Mix the chondral fragments with ACP in the ratio 3:1 through a “female to female” adapter. By pushing back and
forth several times, a uniform, pasty mass is created.

Connect the 1 ml syringe to the application cannula and transfer the fragments into the cannula.

10

Then carefully push the fragments to the cannula tip using the trocar of the cannula, until they appear in the
opening.

11 12

Drain the arthroscopic fluid from the knee and dry the Carefully extend the trocar to apply the fragment
lesion as much as possible. mixture into the lesion.

16 I User Instructions
13 14

Use the back of the cannula to mold the mixture into Then carefully cover the fragment paste with the
the desired position and shape. Make sure that the prepared thrombin serum. Start from the top. The
fragment paste only reaches to about 80 - 90 % of Thrombinator method relies on the blood clotting
the height of the lesion. cascade mechanism. The combination of the fibrinogen
contained in the paste and the thrombin applied creates
a stable clot that holds the mixture in the lesion.

15

For the final seal, mix the PRP with thrombin in the ratio 1:1.

After mixing, apply the mixture quickly to the lesion


from the top, drop by drop, as in step 14.
Then wait for approximately 2 minutes.

16

User Instructions I 17
Quick Guide to Procedure

This diagram shows the approximate chronological sequence of the individual procedural steps and shows
information about when the blood has to be processed in parallel (depending on the system selected).
The times are for guidance only and may vary.

Workflow

Collect the chips,


Arthroscopy, Apply the chips
Preparing the patient transfer / mix
debriding the lesion and seal up
with PRP

Blood
ACP
sampling Thrombinator process Arthrex ACP double syringe
process
45 ml

0 10 min. 20 min. 30 min. 40 min. 50 min. 60 min.

18 I Quick Guide to Procedure


Ordering Information

Product Description Item Number

Arthrex ACP® Double Syringe System


Arthrex ACP® double syringe ABS-10014
Arthrex ACP® kit, series I ABS-10011
Drucker Centrifuge
6-tube horizontal general purpose centrifuge (human use) HORIZON 24-AH
Hettich Centrifuge
Centrifuge, Hettich Rotofix 32 A, with swing out rotor, 220 V 1206-Art
Centrifuge, Hettich Rotofix 32 A, with swing out rotor, 110 V 1206-01-Art
Tubes, for Hettich Rotofix 32 A 1491
Screw cap, for Hettich tubes 1492
Counterweight, for centrifugation of Arthrex ACP® double syringe, 15 ml ABS-10027
Thrombinator™ System
Thrombinator™ system ABS-10080
GraftNet™
GraftNet™ autologous tissue collector ABS-1050
Shaver Blades
Sabre, shaver blade, 3 mm × 7 cm AR-7300SR
Bone cutter, 3.8 mm × 13 cm AR-8380BC
Accessories
Tuohy insertion needle, curved, with obturator ABS-1001

Products advertised in this brochure / user instructions guide may not be available in all countries. For information on availability,
please contact Arthrex Customer Service or your local Arthrex representative.

References

1. Albrecht F. et al. Closure of Osteochondral Lesions Using Chondral Fragments and Fibrin Adhesive. Arch Orthop Trauma Surg (1983) 101: 213 - 217
2. L u Y. et al. Minced Cartilage without Cell Culture Serves as an Effective Intraoperative Cell Source for Cartilage Repair. Journal of Orthopaedic Research
June 2006: 1261 - 1270
3. S tone K. Articular Cartilage Paste Grafting to Full-Thickness Articular Cartilage Knee Joint Lesions: A 2- to 12-Year Follow-Up, Arthroscopy: The Journal of Arthroscopic and
Related Surgery, Vol 22, No 3 (March), 2006: pp 291 - 299
4. Christensen et al. Autologous Dual-Tissue Transplantation for Osteochondral Repair: Early Clinical and Radiological Results; Cartilage 2015, Vol. 6 (3) 166 - 173
5. M
 assen F. et al. One-Step Autologous Minced Cartilage Procedure for the Treatment of Knee Joint Chondral and Osteochondral Lesions; The Orthopaedic Journal of Sports
Medicine, 7(6),
6. F eeney et al. Autologous Cartilage Particulate for Treatment of Cartilage Defects: Impact of Different Arthroscopic Shavers on Viability and In Vitro Migration;
ORS poster 2020
7. B
 orzini P. Mazzucco L. Tissue Regeneration and in Loco Administration of Platelet Derivates: Clinical Outcomes, Heterogeneous Products, and Heterogeneity of Effector
Mechanisms. Transfusion. 2005; 45: 1759 - 1767.
8. Edwards D. et al. Transforming Growth Factor Beta Modulates the Expression of Collagenase and Metalloproteinase Inhibitor. The EMBO Journal. 1987; 6 (7): 1899 - 1904.
9. Lynch S. et al. Role of Platelet-derived Growth Factor in Wound Healing: Synergistic Effects with other Growth Factors. Proc. Natl. Acad. Sci. USA. 1987; 84: 7696 - 7700.

Ordering Information and References I 19


This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals
in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional
judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on
their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s directions
for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results
will vary and not all patients will experience the same postoperative activity level and/or outcomes.
View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking

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