Vidic 2:00
L-13
THE DECISION BEHIND RELEASING THE SYNTHETIC ACL TO THE
PUBLIC
Robert Larkin (rsl16@pitt.edu)
A BASIC LOOK AT CURRENT ACL
SURUGRIES, AND WHATS TO COME IN
THE FUTURE
The ACL is one of the most important ligaments in the
human knee; it connects and helps keep the thigh and shin
bone in place. While it is one of the strongest ligaments in
the body, it is also prone to tearing and injuries. Every year
about 200,000 people in the US tear an ACL [1]. It is a
devastating injury that requires a long healing and recovery
process. Currently there are many surgeries to repair a torn
ACL. The most common surgery is an autograft, where a
replacement tendon for the ACL is taken from another
muscle in the body. These replacement tendons may be
taken from the hamstring or the patellar tendon and many
other places, even from a cadaver, which is called an
allograft [2]. These types of surgeries are effective in
repairing the ACL, but they have some downsides. One
problem with using the patellar tendon is a loss of stability in
the knee because the patellar tendon is another tendon that
runs over the knee and provides its stability [3]. Also, taking
a tendon from a cadaver could lead to infection and disease.
An even bigger downside to this surgery is the long recovery
process. However, recent research could change ACL
surgeries forever.
The use of synthetics in ACL surgeries is currently being
researched to help reduce the pain of the surgery, and also
the recovery time. It reduces the time of the procedure
because surgeons would no longer need to replace the ACL
with another tendon. They could simply implant the
prosthetic ligament [4]. A synthetic ACL would also cut
down on much of the pain and recovery time of a standard
auto or allograft surgery. In one study done on rabbits,
researchers compared the recovery times of rabbits with
synthetic ACLs to those of rabbits that had undergone
autograft surgery. Thirty weeks after the autograft surgery
the autografted ligament was only 15% as strong as a
healthy ACL; whereas twelve weeks after the synthetic ACL
was placed in the rabbit’s knee it was 30% as strong as the
original [1]. This small-scale test on the rabbits shows the
true potential of the synthetic ACL, and how it can seriously
cut down recovery times in patients.
AN ENGINEERS SOLUTION IN AN
ETHICALLY QUESTIONALBE SCENARIO
Let us imagine a scenario in which Paul is the president
of an engineering company. His company makes synthetic
ACLs to be implemented into human knees. The ACLs use
University of Pittsburgh, Swanson School of Engineering 1
2013-10-29
a synthetic scaffolding that is similar to the scaffolding on a
building, to give the new ligament stability and allow it to
grow over time. The scaffolding is seeded, or made with
some of the old ACL cells already implanted into it, so that a
neoligament will form [1]. A neoligament is essentially the
new, synthetic ligament that takes the place of the torn ACL.
His company has perfected the synthetic scaffolding so that
it is able to flow with the knee without breaking, which is
the major problem with many synthetic ACLs.
Even
though it is able to hold up over time, ultimately leaving a
strong and stable neoligament, his synthetic ACL has one
major problem [5]. Ideally he would want the scaffolding to
disintegrate over time, leaving as little scaffolding particles
in the knee as possible. But current tests show his
scaffolding disintegrates very fast, producing acid milieu,
which is very harmful to the body [6].
This fast
disintegration leads to many problems in the ACL,
eventually resulting in failure [7].
Paul’s company is currently doing research to help solve
this problem, and is on the verge of the solution. The new
material they are trying to use for the scaffolding is silk
fibroin, which is a substance that is able to absorb through a
proteolytic enzymatic bio-resorption, which essentially
means that the synthetic scaffolding dissolves away in the
body at a much slower and safer rate then other materials
[6]. The waxy outer layer of the silk can be modified to
regulate the speed at which the scaffolding dissolves.
However, his company has not yet perfected controlling the
dissolving speed. Because the speed of disintegration is not
perfect, the product is not yet ready to be released to the
public.
To test disintegration speeds Paul’s company implanted
the synthetic ACLs in some goats and compared them to
autograft surgeries done in other goats, studying their
recovery over time. At first the goats had swelling and a
hard time with movement, however over time that changed.
Twelve months after the surgeries the goats with the
synthetic ACLs had an average standard deviation of motion
of 4.0±1.8 mm at 90 degrees of flex which is much better
then the average standard deviation of motion in the
autograft surgeries which had a flex of 6.3±1.3 mm at 30
degrees [6]. This not only shows that his synthetic ACLs
performed better then typical autografts, but it also showed
that the silk synthetics work well in a goat’s body. While
this doesn’t prove that synthetic ACLs would work in human
bodies, it does show promise for success.
After working so long on the project and investing so
much into it Paul’s company is running out of money and
funds to continue testing. He is eager to release his product
to the public, but the company has not yet carried out tests
Robert Larkin
on humans and therefore does not have the data to start to
sell the product. So as the manager Paul has to decide
whether he should start selling his product in small
quantities to make more money for research, or completely
scrap the project he had been working on for the last few
years. This is when, as the owner of this company, Paul
must consult the engineering Codes of Ethics to make a
decision.
After going through the NSPE Code of Ethics with still
several questions in mind Paul decided to look specifically at
the Biomedical Engineering Societies, or BMES, Code of
Ethics. In the BMES Code of Ethics one of the canons talks
about the environment, and states that Biomedical Engineers
should, “Support the preservation of a healthy
environment.”[9] If Paul were to make the decision to sell
his synthetic ACL at the current state, would he be
preserving a healthy environment, where patients could
receive the proper care and surgery they thought they were
getting? Clearly he would not be, he would be promoting an
environment where people didn’t get what they thought they
were getting, ultimately leading to many problems in the
future.
Paul continued to consult the BMES Code of Ethics to
see if there were any other points that could help him make a
concrete decision to solve this scenario. He came across a
code that stated; “Report research results with scientific
integrity...”[9] After reading this Paul understood exactly the
decision that he had to make. He realized that deciding to
sell his product prematurely was not the correct decision. It
was unethical to do that. He would be lying to himself and
to everyone else if he were to release fraudulent test results.
There would be no integrity in releasing fake results to the
public, and lying to them. It would only show that his
company had no credibility, and ultimately his product
would worthless. After reviewing the BMES Code of Ethics
he made the decision to not release the product to the public.
Then Paul decided to go back and revisit the past
questions he had when reading through the NSPE Code of
Ethics to make sure the decision he was making made was
the right one. Earlier he questioned, “If my product worked
in goats, why wouldn’t it work in humans?” This is clearly a
foolish question to ask. There are many differences in the
human body and knee compared to a goat. At the time he
was questioning this he was still eager to release his product
and had not really thought this through. Now that he has had
time to go over many Codes of Ethics he realized that just
because it works in animals does not mean that it will work
in humans. Further tests need to be done to make sure the
product works in humans. Paul needs to completely analysis
his past data to make sure it is as safe as can be if his
company ever starts implementing their products into human
bodies.
Paul had also questioned, after going through the NSPE
Code of Ethics, if it was right to put other peoples needs in
front of his own? This was a very hard thing to make a
decision on because obviously he wants what’s best for
himself, but ultimately he came to the decision that putting
other people in front of himself was the ethical choice. If he
were to put his needs in front of others, he would only be
helping himself, and not the people who really need it. He
can sacrifice himself to help the thousands of people dealing
with ACL troubles. Thinking in tis way helped Paul to make
a decision. His company worked to hard and to long to let
them put themselves in front of the others they set out to
CONSLUTING THE CODES OF ETHICS TO
MAKE THE RIGHT DEICSION
After looking at the Codes of Ethics for the National
Society for Professional Engineers of NSPE there are
multiple codes and canons that could be used to solve this
problem. One of the very first canons described say,
“Engineers, in the fulfillment of their professional duties,
shall: 5. Avoid deceptive acts.”[8] This is one thing that
seriously needs to be considered to find a solution for this
scenario.
As manager Paul must ask himself: is
fraudulently making data to show his product is better than it
actually is deceptive? At first it seems very deceptive, lying
to the public about something that they think will help them,
when in actuality it will not. People will go into ACL
surgeries thinking they will be getting the latest and greatest
treatment, and then eventually down the road their synthetic
ACL will fail. This is deceptive, but thinking about all the
time he put into the project Paul begins to question how
deceptive it is. Paul wonders if, “The product showed great
results in goats why would that be any different in humans?”
Paul continues looking through the NSPE Code of Ethics
to hopefully find something that will help him make a
decision. He come across canon 6 which says, “Engineers,
in the fulfillment of their professional duties, shall: Conduct
themselves honorably, responsibly, ethically, and
lawfully…”[8] He began going down the list thinking if he
would be acting in accordance with the code in either
decision. If he decided to sell his product, ultimately having
to deal with the future consequences, would he be acting
honorably, responsibly, ethically, or lawfully? He would
not be doing most of these. He would not be acting
honorably by selling a product that wasn’t yet proven to do
what his company said it could. He would not be
responsible to sell something to people that eventually could
fail on them and cause more complications. Nor would he
be acting lawfully because he would be impacting so many
lives negatively, but at the same time if he didn’t sell the
product he would be impacting his life negatively. He
would lose out on the opportunity to bring a new technology
to people, and all his past work would go to waste. Not only
would he not be able to solve the problem he set out to fix,
he also would have wasted years of his life for essentially
nothing. He questions, “Is it in my best interest to put
everyone else’s needs in front of mine?”
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Robert Larkin
help from the very beginning. If he were to put himself in
the patient’s shoes how would they feel receiving a surgery
they know could be prone to failure. They would feel very
scared and constantly worried that something may happen to
their knee. Because of this it is evident that the ethical
decision in this scenario is to not yet release the synthetic
ACL to the public.
It is clear that Paul made the right decision in this
scenario. He decided to sacrifice all the time in effort he put
into his product to help the people who needed it. By not
releasing his product to the consumer he saved many people
from possible medical complications down the road, and
who knows maybe one day he will get some more money
and can start his research again. Paul heavily consulted the
NSPE and BMES Codes of Ethics to make an ethical
decision. He not only made a good decision to not release
the product, but this can also remind himself to always
consult Codes of Ethics in the future to make ethical
decisions [10]. If engineers always remember to consult the
Codes of Ethics they will always be able to make the right
choice in any situation they are placed in. They must know
and understand the Codes of Ethics in order to make ethical
decisions about the projects they are working on [11].
[3] T. Gifstad, J. Drogset, A. Viset, T. Grontvedt, G.
Hortemo. (2013). “Inferior results after revision ACL
reconstructions: a comparison with primary ACL
reconstructions.”
Knee Surgery Sports Traumatology
Arthroscopy. (Online Article). DOI: 10.1007/s00167-0122336-4. p. 2011-2018
[4] S. Virk, M. Kocher. (2011). “Adoption of New
Technology in Sports Medicine: Case Studies of the GoreTex Prosthetic Ligament and of Thermal Capsulorrhaphy.”
Arthroscopy: The Journal of Arthroscopic & Related
Surgery.
(Online
Article).
http://www.sciencedirect.com.pitt.idm.oclc.org/science/articl
e/pii/S0749806310005864. p. 113-121
[5] J. Bach, F. Detrez, M. Cherkaoui, S. Cantournet, D. Ku,
L. Corte. (2013). “Hydrogel fibers for ACL prosthesis:
Design and mechanical evaluation of PVA and
PVA/UHMWPE fiber constructs.”
Journal of
Biomechanics.
(Online
Article).
DOI:
10.1016/j.jbiomech.2013.02.020. p. 1463-1470
[6] J. Richmond, P. Weitzel. (2010). “Bioresorbable
Scaffolds for Anterior Cruciate Ligament Reconstruction:
Do We Need an Off-the-Shelf ACL Substitute?” Sports
Medicine and Arthroscopy Review. (Online Article). DOI:
10.1097/JSA.0b013e3181cdb493. p. 40-42
[7] S. Bernardino. (2010). “ACL prosthesis: any promise
for the future?” Knee Surgery Sports Traumatology
Arthroscopy.
(Online
Article).
http://www.ncbi.nlm.nih.gov/pubmed/19915821. p. 797-804
[8] (2013). “NSPE Code of Ethics for Engineers.” NSPE.
(Online
Article).
http://www.nspe.org/Ethics/CodeofEthics/index.html.
[9] (2013). “IEEE EMBS Code of Ethics.” EMBS. (Online
Article). http://www.embs.org/images/code_of_ethics.pdf.
[10] B. Lail. (2013). “User-Centered Engineering Ethics
Curricula.” Technology and Society Magazine, IEEE.
(Online
Article).
http://ieeexplore.ieee.org.pitt.idm.oclc.org/xpl/articleDetails.
jsp?arnumber=6524118&tag=1.
p.59-65
[11] J. Basart, M. Serra. (2013). “Engineering Ethics
Beyond Engineers’ Ethics.” Science and Engineering
Ethics.
(Online
Article).
http://link.springer.com.pitt.idm.oclc.org/article/10.1007%2
Fs11948-011-9293-z. p. 179-187
THE ETHICS INVOLVED IN SYNTHETIC
ACLS
In the end synthetic ACLs are very important for the
future of ACL surgeries and need to be continually
developed to solve the problems of the traditional autograft
surgeries. With the amount of current research and
development a compatible synthetic ACL is in our near
future. ACL surgeries would become less worrisome
because recovery time is much shorter with synthetic ACLs
when in comparison to auto or allografts. However, for
synthetics to be the useful medical device it seems they will
become, companies need to act in ethical ways. Companies
must follow the Codes of Ethics in order to benefit the
people that need help as opposed to being selfish and all
about themselves. Engineers must be able to not only
account for their decisions but the decisions of others as
well, so that proper ethical decisions are made. If engineers
are able to do this, the future for ACL surgeries looks very
promising.
ADDITIONAL SOURCES
REFERENCES
“ACL Prosthetics Project: Carol C.” YL C. (2011). (Video).
http://www.youtube.com/watch?v=8z-8ArXAwkM
“Tavor Knee-T-Nol™ ACL prosthesis.”
Knee-T-Nol.
(2011).
(Video).
http://www.youtube.com/watch?v=V2vmhdTwNqk
[1] K. Ravn. (2007). “A new ligament -- from scratch.”
Los Angeles Times.
(Online Article).
http://articles.latimes.com/2007/mar/12/health/he-labbox12
[2] P. Chambat, C. Guier, B. Sonnery-Cottet, J. Fayard, M.
Thaunat. (2013). “The evolution of ACL reconstruction
over the last fifty years.”
International Orthopedics.
(Online
Article).
http://www.ncbi.nlm.nih.gov/pubmed/23322063. p. 181-186
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Robert Larkin
ACKNOWLEDGMENTS
I would like to thank my floor mates for helping me with
questions about formatting. I would also like to thank all the
people at the Writing Center who helped me edit my paper
and gave me tips for writing the rest.
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