Pinn-ACL® CrossPin System Welcome

DEC | 2005 | Issue NO. 1
ConMed Linvatec Sports Medicine News and Product Information
Welcome
in this issue:
Clinical Focus
Theory of the ThRevo™
Stephen J. Snyder, MD
2
Impact™ Suture Anchor
4
The “Complete System”
Soft-Tissue ACL
Reconstruction
2, 3
Surgeon Testimonial:
Pinn-ACL CrossPin System 3
What‘s New
Pinn-ACL CrossPin System 1
3
New Advances In
Sports Medicine
6
Meetings and Workshops
6
We look forward to your feedback
about the premier edition of THE
SPORTS MEDICINE NEWSLETTER.
Please email us at: sm@linvatec.com.
Customer Service
Phone:
1-800-237- 0169
Fax:
1-727-399-5256
International Fax: 1-727-397- 4540
Web:
www.linvatec.com
e-mail:
sm@linvatec.com
©2
005 Linvatec Corporation, a subsidiary of
ConMed Corporation, 11/05, COS 9107
With over 40 years of experience, ConMed Linvatec
is recognized as a leader in the development and
manufacture of arthroscopic instrumentation. We
pioneered the development of the first disposable
arthroscopic shaver blade, manufactured the first
bioabsorbable interference screw, introduced the first
autoclavable 3-chip video camera, and we are the global
market leader in fluid management systems. Additionally,
our commitment to Medical Education has served to build
strong relationships with our customers worldwide.
Utilizing our expertise in biocomposite materials, surgical
instrumentation, and implant development, ConMed
Linvatec continues to provide new and innovative products,
the aim of which is to reduce healthcare cost, enhance
surgical efficiency and most importantly, improve clinical
outcomes. With facilities in Largo, Florida, Santa Barbara
and Anaheim, California, and Tampere, Finland, ConMed
Linvatec is well positioned to provide these new products
and technologies today, and into the future.
I hope that you will find this newsletter to be educational
and informative. We look forward to receiving your
feedback and input into future issues.
Sincerely,
Gerald Woodard
President, ConMed Linvatec
Pinn-ACL CrossPin System
®
Orthopedic Fracture
Fixation
Calendar
It is with great pleasure that I
welcome you to the premier issue
of the ConMed Linvatec Sports
Medicine Newsletter. The purpose
of this quarterly publication is
to keep you, our customers, up
to date on the latest products,
techniques, and technology in the
area of arthroscopic surgery. In
each edition of this newsletter, clinicians and medical
educators from around the world will share the latest in
surgical techniques, clinical pearls of wisdom, innovative
technology applications, and much more.
ConMed Linvatec is pleased to announce the release of
the Pinn-ACL CrossPin System instruments and implants.
This system is designed for transverse femoral fixation
of soft tissue grafts in Anterior Cruciate Ligament
reconstruction, allowing for increased pull-out strength.
With the pull-out strength of the Pinn-ACL CrossPin
implant at approximately 1700* Newtons, the femoral
fixation greatly surpasses normal forces applied to the
reconstructed ACL during the rehabilitation phase.
With existing systems on the market, the concern has been
the possible deforming of the femoral tunnel when using a
wire to pass the graft or the damage to the collagen fibers
caused by spearing the graft with pins. Lastly, the lack
Features: CrossPin material
(SR-PLLA)
Graft Harness and
CrossPin interface of confidence in a solid graft-to-pin interface may
result in post-operative concern for adequate fixation
of the graft. Our system passes the graft using standard
techniques of graft/tunnel sizing, protects the graft
using our Graft Harness system with the high strength
polyethylene Dyneema fiber loop, and allows the
surgeon to see the exact path of the CrossPin through
the Graft Harness.
Utilizing a scope in the transverse tunnel, the unique
system and surgical technique allows the surgeon to
visualize the exact point of femoral fixation. Precision,
reproducibility and confidence are built into the
Pinn-ACL CrossPin System!
Benefits:
–Proven bioabsorbable
– Superior implant strength
– Increases pull out strength
–Prevents graft slippage and micro motion
– Eliminates need to spear the graft
Unique surgical technique –
Instrument design incorporates
–
3-point precision reference system
High-strength fiber,
–
continuous loop design
–
Allows for scope visualization of transverse tunnel
and Graft Harness to CrossPin interface
Allows for consistent accuracy in transverse tunnel
placement and implant cortical length selection
Offers an atraumatic graft passing/fixation design
360° graft to bone contact providing more surface area contact
S p orts M edicine
2
Theory of the ThRevo® Anchor
Stephen J. Snyder, MD
From the time of Codman, it has been
recognized that the torn rotator cuff has
the ability to heal to the prepared humeral
tuberosity if it is securely anchored to the
exposed cancellous bone without unphysiologic
tension. The pioneers of shoulder surgery
advocated using simple or mattress sutures
passed through bone tunnels adjacent to the
edge of the articular cartilage to secure the
fixation. The assumption was that securely
attaching the torn tendon to bone with the least
possible tension was the best way to insure that
it would heal. The most important factor was
the security of the attachment sight and not the
vaunted “footprint”. Never before in the history
of shoulder surgery has a respected shoulder
surgeon deemed it necessary to pull the tendon
out to an unnatural length in order to reestablish a “footprint” on the tuberosity. If that
were the case, shouldn’t present-day shoulder
surgeons be reporting unacceptable failures in
their arthroscopic cuff repair cases?
The ThRevo anchor was
developed to augment
the strength of the suture
fixation of the torn
rotator cuff tendon to
bone using the theory of
a single medial row. By
using three, rather that
two sutures per anchor
the number of balanced
fixation points in the
cuff can be increased
using the minimal
number of anchors.
The ThRevo eyelet has
been designed in a horizontal orientation
so that each of the three sutures will slide
independently of the other two allowing use of
secure sliding locking knots. The
sutures may be passed in various
patterns: as three simple sutures,
a central mattress with two outside
simple sutures or as a Castagna
stitch having the central suture
function as a horizontal rip-stop
or “Mac”stitch and the outside
simple sutures passing medial
to it.
Recently there has been an
incredible flood of reports
and podium presentations
extolling the potential benefits
of using an additional row of
suture anchors. The suggestion
is that by having one row of
sutures at the edge of the cartilage
and another further lateral on the
tuberosity, cuff healing will somehow be
enhanced. Without any proof of this theory, the
proponents have speculated that this practice
of applying an additional percentage of the
cuff tendon to the bone
over the native footprint
will improve the healing
of the tendon to bone.
There is no doubt that
adding additional
sutures to hold the cuff
stump will increase the
pullout resistance and
should thereby promote
more secure fixation to
bone. But the methods
suggested to increase
the holding power
by using additional
anchors to make
available more sutures seems unnecessary. A
damaging consequence that may ultimately
arise from lateral placement for “double row”
surgeon testimonial:
Pinn-ACL CrossPin System
“…my initial feeling is that the reconstructed knees feel more solid with less
laxity compared to my previous techniques,” said Dr. Haw Chong Chang
of Changi General Hospital, Singapore. “It is exciting! The ability for me
to visualize and confirm the positioning of the pin through the harness hole
provides a lot of confidence during femoral fixation.”
Dr. Haw Chong Chang
Changi General Hospital, Singapore
repair may be that as a shortened tendon
and it’s contracted muscle are subjected to
unnatural stress causing the muscle to stretch
beyond the natural Starling muscle-tension
curve. This stress in a chronic situation may
lead to either overstrain injuring the muscle or
the eventual stretching and failure of the cuff
repair as it reverts back to the normal resting
tension or “tension overload”. (Ref.1)
The “theory of the ThRevo anchor” is simply to
employ an inexpensive method to maximize the
fixation of the torn tendon to bone using three
rather than two sutures from each anchor. It has
been proven by Morley and Barber (Ref 2.)
that this ThRevo method increases the holding
power of the fixation system by approximately
50% per anchor (compared to two sutures per
anchor) without requiring extra anchors or
increasing the tension on the repair.
Unless and until honest and respected shoulder
surgeons demonstrate that using additional
suture anchors to form a lateral row actually
promotes better healing of the torn rotator cuff
it makes no sense to add additional cost, time
and difficulty to the rotator cuff repair operation
for no proven benefit.
Ref. 1
Burkhart SS, Diaz Pagan JL, Wirth MA, Athanasiou KA.
Related Articles, Links Cyclic loading of anchor-based
rotator cuff repairs: confirmation of the tension overload
phenomenon and comparison of suture anchor fixation
with transosseous fixation.
Arthroscopy. 1997 Dec;13(6):720-4.
Ref. 2
Barber F, Herbert M, Coons D. ThRevo Anchor Study.
Spring AANA 2005; Poster Exhibit.
S p orts M edicine
3
The “Complete System” Soft-Tissue ACL Reconstruction
ConMed Linvatec strives to produce the best
products available for use in arthroscopy.
Our latest combination of products for soft
tissue ACL reconstruction offers the surgeon
a “Complete System” approach to obtaining
a reproducible and balanced repair. By
combining the Pinn-ACL® Femoral CrossPin
system, which boasts a pullout strength of
approximately 1700* N (Newtons), with the
BioScrew® Xtralok® interference screw's tibial
pull-out strength of approximately 1400*N,
we approach the boundaries of a balanced
repair. Using the SE (Stress Equalization)
Graft Tensioning System, allows the surgeon
to reproducibly distribute the load placed
on the graft construct calculated from the
individual bundle measurements, and “in-vivo”
graft conditioning. By utilizing this system, the
variability previously inherent in soft tissue ACL
reconstruction has been greatly reduced, if not
eliminated.
AVAILABLE REFERENCES:
Chang HC, Nyland J, Nawab A, Burden R, Caborn D.
Biomechanical Comparison of the Bioabsorbable RetroScrew
System, BioScrew® XtraLok® With Stress Equalization Tensioner,
and 35-mm Delta Screws for Tibialis Anterior Graft – Tibial
Tunnel Fixation in Porcine Tibiae. Am J Sports Med. 2005; Vol.
33, No. 7, 1057-1064.
Volesky M, Pickle A, Bessette B, Wilkinson R, Dervin G,
Johnson D. Comparison of XtraLok Versus Intrafix Tibial Fixation
in Hamstring Anterior Cruciate Ligament Reconstruction: A
Randomized Clinical Trial. J Knee Surg. 2004; Vol. 17,
No. 4, 249.
*Pull-out data on file
Orthopedic Fracture Fixation
Demographically, with 6 billion people
worldwide and two fractures per person per
lifetime, the incidence of fractures likely will
not slow over the next few decades. Couple
these solid, healthy demographics with not only
a more active population, but also increased
industrialization and access to healthcare in
certain parts of the world, and the future of
fracture repair will continue to grow. Steady
growth should characterize this segment of the
market for decades.
There is also a continued market shift towards
resorbable and next generation devices. This
will continue for at least the next five years.
ConMed Linvatec is able to provide a patented
“Self–Reinforced” bioabsorbable implant to
facilitate repairs of fractures in the shoulder,
elbow, wrist, knee, foot and ankle. Repairs of
OCD lesions, ligaments, and corrective surgery
necessary due to diseases of the bone and
joints of the body are also accomplished by
using our implants and repair systems.
Market Drivers
–Aging population
–Less invasive procedures
–Self-Reinforced implant design
enhancements
–Simplified instrumentation sets
–Continued market shift towards
resorbable fixation devices
–Growing number of arthroscopy and
open procedures
The following is a list of the repair systems
available for this product line:
SmartScrew®
SmartNail® (Bone Fixation Kit)
SmartPin®
SmartTack®
Please contact your local Sales
Representative for additional information.
S p orts M edicine
4
Impact™ Suture Anchor
ConMed Linvatec’s latest bioabsorbable
implant, the Impact Suture Anchor, is unique – it
is among few suture anchors that can be used
for both instability and rotator cuff repairs. The
development of the implant, instrumentation
and surgical technique was done in conjunction
with two world-renowned shoulder surgeons:
Mark Field, M.D., of Baton Rouge, Louisiana,
and Jeff Abrams, M.D., of Princeton, New
Jersey. The Impact anchor's notable wing
design is rotated under the cortical layer of
bone and is toggled to lock it in place. This
“active toggle” system is distinct compared to
the other “passive toggle” anchors that may
not consistently lock into the bone.
The Impact Suture Anchor is made of a SelfReinforced PLA copolymer that retains 90
percent strength for approximately 20 weeks
and, over time, breaks down and is eliminated
from the body. The unique cone shape and
wing provide a tight fit on the inserter and
allow for simple and consistent deployment in
the bone.
This anchor is pre-threaded with two different
color strands of non-absorbable, braided,
polyester suture, or our highly successful
Herculine™ high-strength suture. These sutures
are in separate compartments of the suture
handle, which means they do not tangle during
insertion — a real time saver in the operating
room. Additionally, the sutures are pre-threaded
through separate eyelets for independent and
simple suture manipulation and management.
Key Product Specifications:
The Impact Suture Anchor is accompanied
by several reusable instruments including a
Notcher for hard bone, Drill Guide, Drill Guide
Obturator, 3.5mm Drill Bit and Sterilization
Tray.
Furthermore, due to its size and unique shape,
the Impact anchor should be your top choice
when another anchor has pulled out of the
bone and left you with a large pilot hole to fill.
This anchor toggles horizontally and therefore
will fill most voids left behind by another
anchor. This makes the Impact your ultimate
“back-up” anchor.
– Material = SR – 96L/4D PLA
– Cone diameter = 3.5mm
– Anchor length = 10.5mm
–Pre-threaded with two strands of either
#2 non-absorbable, braided, polyester
suture or #2 Herculine™ High Strength
Suture
– Drill Bit diameter = 3.5mm
Key Product Benefits:
– Active toggle fixation system
–Unique bioabsorbable anchor allows
for quick, easy placement and setting
in all bone types
– Two sutures at one fixation point
Mark Field, M.D. commented on his experience
with the system, “the instrumentation allows me
to create a consistent environment to deploy the
implant in all types of bone. I have also seen
a decrease in anchor pull-out with this implant
compared to others I have used in the past.
Finally, my OR personnel like the versatility of
the implant because we can use it for multiple
indications.”
–Ideal system for instability and rotator
cuff repair
–Two separate eyelets allow the sutures
to slide independently of one another
–Ultimate “back-up” anchor due to size
and unique wing design
Impact Suture Anchor Strength Characteristics*
250 ....................................................................................................................
Force (N)
200 ....................................................................................................................
150 ....................................................................................................................
100 ....................................................................................................................
50 ....................................................................................................................
227 N
133 N
188 N
0
* Data on file.
#2 Suture
(Ultimate Strength
of Double Strand)
Impact Anchor Pull-out
(Anchor Pull-out Force
Cadaveric Humeri study)
Impact Anchor Pull-out
(Anchor Pull-out Force
Cadaveric Glenoid study)
Call for Papers
Abstract Deadline:
January 16, 2006
Submit abstracts to:
Laurie Hiemstra, M.D., Ph.D. and John Mehalik, M.D.
Residents & Fellows Arthroscopy Conference
11311 Concept Boulevard, Largo, Florida 33773-4908
or
E-mail submissions to:
ksousa@linvatec.com
For information:
Contact Karen Sousa
Conference Organizer
(800) 325-5900, ext. 5349
The conference provides a forum for presenting original
clinical and basic science research, an opportunity to
exchange ideas with your peers and debate with an
accomplished faculty, lead by Don Johnson, M.D., FRCS.
Abstracts must represent original papers authored or
co-authored by fellows or residents on subjects clinically
relevant to sports medicine and arthroscopy. Abstracts
should be one page in length, not to exceed two pages.
Participants must be 4th or 5th year residents, fellows,
or in their first year of practice to meet the eligibility
requirements. First year practice participants must
present papers from their residency or fellowship program
the previous year. To maintain the informal atmosphere
of this conference only 15 abstracts will be accepted for
presentation. An educational grant is being provided by
ConMed Linvatec, which includes accommodations and
an airline ticket allowance.
Provided through an education grant from ConMed Linvatec.
S p orts M edicine
New Advances In Sports Medicine
Dr. Nick Sgaglione
We live in exciting times as we all continue
to witness with great interest several rapidly
expanding and evolving trends in orthopaedics
and in sports medicine – arthroscopy in
particular. New developments related to the
practical application of minimally invasive
surgery, computer navigated techniques and
biotechnology have captured our attention and
our imagination and will no doubt continue to
change the way in which we approach patient
care. Most clinicians and basic scientists would
agree that the next 5 years will most certainly
yield exciting advances in the orthopaedic
disciplines.
bone graft substitutes and increasingly defined
bioactive growth factors.
In an effort to better focus our attention as
clinicians on many of these rapidly changing
biotechnologies, we have prepared a “state-of
-the-art” symposium dedicated to “Biological
Advances and Innovative Materials in
Arthroscopy”. We look forward to an exciting
and educational forum and interesting
discussion.
Up Coming Events
2006
5 – 7 January
Southeastern Fracture Symposium
Greensboro, NC
20 – 22 January
OLC-AAOS/ASES Open and
Arthroscopic Techniques in Shoulder
Surgery
Rosemonet, IL
27 – 29 January
OLC-AANA Hip Course
Rosemont, IL
Most significantly, we can anticipate more
practical articular cartilage biosurgery, more
advanced complex biodegradable polymers,
more controlled osteoconductive bioceramic
You are invited to a symposium
6
3 – 5 February
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Biological Advances and
Innovative Materials in Arthroscopy
Faculty: Nicholas A. Sgaglione, MD
F. Alan Barber, MD
Self-Reinforced BioAbsorbable
Implants Feature:
• Increased mechanical strength
• Withstand higher insertion forces
• Offer selection of materials with varying
degradation characteristics
Proven combinations of benefits and attributes define the Material Advantage,
which has allowed more than a million patients and surgeons to enjoy
reproducible clinical outcomes.
OCL-AAOS Advanced Techniques
in Foot and Ankle Surgery
Rosemont, IL
4 –7 February
Arthroscopic Surgery 2006 (Metcalf)
Sun Valley, ID
10 – 12 February
OLC-AANA Shoulder Course
Rosemont, IL
19 – 23 March
AORN
Washington, DC
20 – 24 March
American College of
Foot and Ankle Surgeons
Mandalay Bay Resort, Las Vegas, NV
22 – 24 March
American Academy of Orthopaedic
Surgeons (AAOS) Annual Meeting
McCormick, Chicago, IL
Register with your Business Card, or fill-out the form, at booth #100
30 March – 2 April
Fall AANA • Desert Suite II
December 2, 2005
5:30 pm to 6:30 pm
OLC-AANA Resident Course
Rosemont, IL
Seating is limited to the first 50 registrants
Exclusive gift to all registrants