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   FROM BIONIC TO BIOLOGICAL: THE EXPLORATION OF BIOLOGICAL
                      JOINT REPLACEMENT

                      Angela Beck (amb283@pitt.edu), Shannon Gorman (slg81@pitt.edu)

Abstract-This paper will focus on the breakthrough science             joint with an orthopedic prosthesis [5]. Although the
of self-healing biological joint replacements. Although this           procedure has shown positive results, it also causes problems
technology can be applied to all joints, we will focus                 and complications, including malfunctions of the prosthesis,
specifically on the positive effects it will have on the hip.          infections, and recalls. Because of these drawbacks, which
Biological joint replacement involves taking cells from the            occur in 13-20% of patients, many individuals endure
patient and placing them in a scaffold, a structure made of            additional surgery [4]. To decrease the large number of
cells that support tissue regeneration. We will explain the            revision surgeries and improve the lives of those who suffer
biology and chemistry of these scaffold frameworks infused             from arthritis, a new solution is needed. Biological joint
with growth factor hormones that self-heal the damaged                 replacement is the most logical and ethical solution to
area(s) of the joint. We will state the advantages of using            solving the problems of artificial joint replacement.
less invasive biomaterials, rather than metal prostheses, to
treat arthritis. The past successes and outcomes of animal                       EXPLANATION OF THE HIP JOINT
testing and research will be discussed along with the next
steps scientists will take to implement their discoveries in           Many elements work together to produce the functioning hip
humans. This paper will address the ethical concern of                 joint. This joint is located where the femur meets the ilium,
artificial prosthetic recalls, detail the techniques that              ischium, and pubis, the three bones that form the pelvis. It is
scientists propose will work best, and discuss the                     classified as a ball-and-socket joint, because the ball-shaped
technology’s impact on improving sustainability and quality            end of the femur fits into the socket of the hipbone. The hip
of life. The medical world has long awaited advancements in            socket, known as the acetabulum, is located on the outer
joint replacement research, and the exploration of self-               edge of the pelvis. A slippery, smooth cushion, called
healing biological joint replacements is the best approach to          articular cartilage, covers the femoral head. This cartilage
curing those who suffer from arthritis.                                consists of strong yet flexible tissue that is great for bearing
                                                                       weight. Protected by synovial fluid, which enables joints to
Key Words- Arthritis, Biological Joint Replacement, Growth             work properly under great pressure, the articular cartilage
Hormone, Joint, Scaffold, Self-Healing, Prosthetic.                    allows the femur to painlessly rotate and glide within the
                                                                       acetabulum [2].
                  THE NEW SOLUTION                                         To maximize stability, ligaments and muscles surround
                                                                       the hip joint. Some of these ligaments include the
The hip joint is one of the largest and most important joints          iliofemoral, pubofemoral, and the strongest ligament of the
of the human body. It has many duties, including providing             body, the ischiofemoral. Together, these ligaments form
stability and range of motion and serving as a junction that           what is known as the joint capsule.               The muscles
connects important bones and muscles of the body.                      surrounding the hip joint also work together to keep the hip
Unfortunately, this joint is often injured. Osteoarthritis is          stable and allow movements, including flexion, extension,
the leading disease that causes pain, discomfort, and damage           abduction, and adduction. These four basic movements
to the joints of the body. One in eight Americans is affected          allow the hip to bend, straighten, take the leg away from the
by this disease, and almost half of the world’s population             body, and bring the leg back toward the body. In addition to
over the age of sixty-five are diagnosed [1].         Arthritis,       ligaments and muscles, the hip joint is surrounded by fluid
specifically of the hip, is caused by the wearing away of              filled sacs called bursae. These sacs, which are lined with a
articular cartilage, which is located on the head of the femur         synovial membrane that produces synovial fluid, are crucial
and the acetabulum, the socket where the femur attaches. As            to the smooth movements of the hip. As many as twenty
this layer becomes thinner, the bones are unable to glide              bursae are located around the hip to reduce friction, allowing
smoothly past one another, causing pain, swelling, and lack            the hip move with ease. These components, which are
of motion [2]. Since the 1960’s, total hip replacement                 pictured in Figures 1 and 2 below, create the functional hip
surgery has been used to heal damaged joints and alleviate             joint [2].
discomfort. [3].
    According to the Centers for Disease Control and
Prevention, over 600,000 hip replacements are performed
each year [4]. Hip replacement is the most common
arthroplasty, the replacement of an arthritic or dysfunctional

University of Pittsburgh
Swanson School of Engineering                                      1                                                   April 14, 2012
                                                                                                                    Angela Beck
                                                                                                                Shannon Gorman




                     FIGURES 1 AND 2                                                            FIGURE 3
         BONES AND LIGAMENTS OF THE HIP JOINT [2]                     METAL PROSTHESIS USED IN ARTIFICIAL JOINT REPLACEMENT
                                                                                                [3]
   THE PRESENT SOLUTION: ARTIFICIAL JOINT
               REPLACEMENT                                               OUT WITH THE OLD AND IN WITH THE NEW

There are over 60 different types of artificial hip                   The less invasive procedure of biological joint replacement
replacement surgeries, but the most common involves the               surgery involves just a few steps done by the surgeon. The
insertion of a metal femoral component [3].           Total hip       patients’ cells naturally heal the rest of the joint on their
replacement surgery involves many steps. First, the femur is          own. First, the surgeon removes the damaged areas of the
removed from the hip socket [6]. Next, the damaged                    femur and hip socket. Next, to regenerate the injured areas,
femoral head is carefully removed along with the injured              a customized bioscaffold is implanted in the hip joint. This
cartilage and bone of the hip socket [3]. A metal cup is then         scaffold has been previously infused with collagen gel, a
fitted into the bare hip socket. After this cup is firmly             flowable matrice that is commonly used for drug delivery.
inserted, the femur is hollowed out and a metal prosthesis is         No other previously prepared cells or stem cells are added to
implanted into the newly formed canal of the thighbone [6].           this structure before installing it into the patient’s hip joint.
For a secure fit, cement is often used to hold the implants in        The collagen gel in the bioscaffold contains transforming
place. Then, a prosthetic femoral head is attached to the end         growth factor β3 (TGFβ3), which is used to stimulate
of the metal femoral stem, replacing the damaged head that            chondrogenesis, the formation of cartilage [1]. The growth
was previously removed. Afterward, a spacer made of                   factor encourages the damaged cells of the patient to
plastic, ceramic, or metal is prepared to fit snugly into the         transform into new, healthy cartilage and bone cell. Due to
new hip socket. This insert produces a smooth gliding                 the abundance of these new cells, no additional harvested or
surface that allows the hip to function properly and                  implanted cells are required, which is a major advantage of
efficiently. Lastly, the femoral head, along with the spacer,         this technique. [7]. Once this scaffold is inserted into the hip
is inserted into the metal cup implant of the hip socket to           joint, the patient’s body completes the process. First, cell
form the artificial ball and socket hip joint [3]. Figure 3 is        homing takes place, which is the migration of precursor cells
an example of the prosthetic used for artificial surgery and          to the scaffold. Precursor cells are unspecialized cells from
its insertion into the femur and socket of the hip joint.             which new specialized cells, such as cartilage and bone,
                                                                      form. Once these cells settle in, the tissues around the hip
                                                                      joint actively respond to their presence, with the help of the
                                                                      TGFβ3. In turn, the healthy precursor cells reproduce,
                                                                      replacing the injured cells of the hip joint. This reproduction
                                                                      creates an entirely new joint surface that contains healthy
                                                                      articular cartilage, ridding the patient of arthritis. [1].




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                                                                                                                       Angela Beck
                                                                                                                   Shannon Gorman

          BIOLOGICAL VERSES ARTIFICIAL                                   know that the surgery will reduce the pain and discomfort.
                                                                         This helps the patient both physically and mentally.
Artificial hip replacement surgery poses risks. Common                   Physically, the individual will regain almost all hip
problems include loosening, dislocation, wear, and/or                    movement and strength, which is better than the success of
breakage of the prosthesis. Along with complications of the              artificial replacement. Furthermore, the patient will not be
prosthesis, other problems can develop. One example is                   so afraid to undergo the surgery, because the chances of
impaired nerve function, which usually evolves in the area               having complications or needing additional surgery are
where the surgeon corrected joint deformity to implant the               greatly reduced.
prosthesis. As with all surgeries, there are also risks from                Clearly biological joint replacement is the best solution to
undergoing anesthesia, infections, or blood clots, most                  curing individuals who suffer from arthritis. Biomedical
commonly in the leg veins or pelvis [14]. All of these                   scientists should make this technology a high priority. This
impediments can cause substantial pain, require additional               technique must be utilized to save patients from the dangers
surgery, and can even be life-threatening.                               and complications of artificial joint replacement surgery.
    Because of these complications, artificial joint
replacements are proven to have short lifespans, especially                       ETHICAL SOLUTIONS TO RECALLS
for those of young age [9]. Young individuals are much
more active because many exercise regularly, have jobs that              Another current issue of artificial joint replacement is recalls
involve travel, and have young children. The prosthetics                 on the artificial prosthetics implanted during surgery. While
used in artificial hip replacements are unable to withstand              the number of joint replacements in the United States
the active lifestyle of these individuals; therefore, many of            approaches 1 million annually, approximately 160,000 joint
them break or cause other problems previously discussed.                 replacement recipients undergo revision surgery [12]. This
    Biological joint replacement would eliminate the dangers             issue can cause devastating injuries that are worse than the
artificial replacements pose. Instead of using a metal,                  patient’s condition before surgery. The high failure rate of
ceramic, or other type of artificial component, biological               artificial prostheses is especially common in the presently
joint replacement repairs the joint by replacing the damaged             used all-metal joint replacements.           Manufacturers of
areas with cells [7]. Because the body easily recognizes                 artificial joints are constantly making “newer and better”
these cells and is already accustomed to their presence, this            models that supposedly have been thoroughly researched
technique is far less invasive. It also eliminates the                   and tested. Recent studies have shown that the performance
damaging steps involved in artificial replacement, such as               of the new models is far worse than the prosthetics they
the reconstruction of the femur and hip joint. Instead of                replaced--as one-third of them fail every five years. One
hollowing out the femur and carving away most of the                     estimate places the average hospital and medical bills for
contents of the hip socket, biological joint replacement                 one patient at $300,000. This expensive cost, multiplied by
simply requires the insertion of a small cellular scaffold.              each patient who undergoes the surgery, totals to billions
This process is less complex than that of artificial joint               end even trillions of dollars that must be covered by patients,
replacement, allowing for a faster, and smoother recovery.               the government, insurance companies, and taxpayers [13].
    Biological joint replacements also last longer, as its                   In addition, the physical and emotional effects that recalls
components are not easily worn away or broken. Once                      have on patients must be considered. Having to undergo any
again, this is especially important for younger and active               kind of surgery is painful, but enduring additional corrective
individuals. The likelihood of needing revision surgery after            surgery/surgeries to remove a defective replacement causes
having a biological hip replacement is much lower compared               significant damage to tissue and bone [13]. Patients who
to patients who received a prosthetic joint. Upon                        undergo any type of surgery must have trust in doctors and
replacement of damaged parts of the joint, the hip returns to            nurses. If the artificial joint is recalled, it is more difficult
its original state of function. This is not the case in artificial       for the patient to have the same confidence in the
replacement. The range of motion is therefore restricted in              professionals performing the surgery, which can cause
some respect for those with prosthetics, while patients who              stress, depression, and anxiety.
undergo biological hip replacement regain full mobility.                     Unfortunately, pinpointing one manufacturer or faulty
    Lastly, biological joint replacement eliminates the                  device cannot solve the issue of recalls. The problem is so
possibility of recalls, since only natural materials are used in         widespread that it would take the government years and
the procedure. This improvement has immense benefits for                 additional funds to sort out the matter. Implanting a patient
both doctors and patients. The doctor performing the                     with a device that has the possibility of failure or being
surgery would not have to worry about putting faulty                     recalled raises an ethical problem. A manufacturer or doctor
prosthetics into his/her patient, and as a result, they would            who gives a dysfunctional prosthetic to a patient violates the
not have to fear being sued. In addition, biological joint               Hippocratic oath. Biological joint replacement is the ethical
replacement is even more beneficial to the arthritic patients.           solution to the problems of individuals with arthritis. The
By eliminating the possibility of recalls, the patient will              implementation of this technique will alleviate the ill effects



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                                                                                                                   Angela Beck
                                                                                                               Shannon Gorman
of recalls that produce additional cost, physical pain,               Artificial replacements deteriorate over time, just as all
emotional damage, and excessive recovery time.                        joints do, but at an even faster rate. Biological joint
                                                                      replacement would provide the sustainability a joint needs to
     BECOMING BIOLOGICALLY SUSTAINABLE                                function painlessly and with ease, never needing repairs or
                                                                      replacements.
                                                                          A person suffering from arthritis or a faulty prosthetic
Sustainability is a long-term goal that every company,                experiences a decline in their quality of life due to pain in
doctor, research group, etc. must strive for. Sustainability is       the affected joint/joints. Quality of life involves matters that
the capacity to endure, and it involves environmental,                make life more enjoyable, worthwhile, and stress free.
economic, and ethical dimensions.                                     Compared to artificial joint replacement, biological joint
    The manufacturing process of artificial prosthetics causes        replacement would produce these positive results. Life with
depletion of resources, energy loss and pollution. Most               a biological joint replacement would be less burdensome to
components of artificial replacements, especially metal, are          the patient as they would have fewer days when joint
nonrenewable resources. With the increase of patients in              discomfort affects their mobility. Quality of life also
need of joint replacements, these resources are continuously          involves extending one’s lifespan in ways that ease the
being consumed. While these metals are readily available              process of aging. By reversing the decay of articular
today, they will not be in the future if their use in this            cartilage in arthritic joints, biological joint replacement
procedure continues. Cells, in contrast, can always be                creates an entirely new and healthy joint that functions as if
reproduced so long as humans live. By using natural                   it were years younger.
materials instead of metal devices, biological joint                      Whether comparing environmental, economic, or quality
replacement improves sustainability. Nonrenewable energy              of life concerns, biological joint replacement far exceeds the
loss is another problem. A metal component as small as an             capabilities of artificial joint replacement surgery.
aluminum can has the ability to run a television for three            Biological joint replacement is the body’s way of being self-
hours. This number multiplied by the hundreds of thousands            sustaining.
of artificial joint replacement surgeries performed each year
amounts to a massive energy loss.                 In addition,
manufacturing plants producing these devices use machines
                                                                                        PRESENT RESEARCH
that release chemicals and other harmful substances into the
environment. Biological joint replacement eliminates these            Researchers James Cook of Missouri University and Jeremy
problems because it requires only a minute amount of energy           Mao of Columbia University are at the forefront of
and machinery to create the scaffolds used in the procedure.          biological joint replacement research. These scientists found
    Economically, converting to biological joint replacement          a way to create biological joints in animals and plan to
will save money wasted on revision surgeries and the                  implement their discoveries on humans in the near future. A
production of artificial prostheses. Because so many                  detailed description of their study was published in The
replacement surgeries take place each year, the cost of               Lancet, the world’s leading medical journal, on August 6,
manufacturing artificial implants is expensive. Therefore,            2010. The scientists hypothesized that if they embedded a
the price of artificial replacement surgery continues to rise.        bioscaffold containing a biological “signal” into a rabbit’s
Unfortunately, not all arthritic patients can afford the              injured joint, it would regenerate the articular surface. To
surgery. Biological joint replacement would solve this                test their theory, the two scientists removed the entire
ethical and economic issue. It is a new technology that               articular surface of the humeral condyle in mature rabbits
reduces the consumption of resources therefore lowering the           [9]. They then inserted scaffolds containing transforming
amount of money spent to repair or replace defective                  growth factor β3 (TGFβ3)-absorbed or TGFβ3-free collagen
artificial replacements. Because the cost of creating the             hydrogel [8]. Recordings of the structure of the shoulder
scaffold used in the procedure would be far less than                 joint using a laser scanner were used to create a specialized
artificial prosthetics, the cost of surgery would decrease and        scaffold, containing polycaprolactone and hydroxyapatite
more patients would be able to afford the joint surgery.              [9].
    While most individuals would relate sustainability to                 Polycaprolactone (PCL) is a biodegradable polyester that
environmental and economic issues, another important                  has been approved by the FDA for uses such as drug
aspect should not be ignored. Biological joint replacement            delivery. This material is compatible with soft and hard
improves quality of life. The human body slowly                       tissue, which are both found in the hip. When reacted with
deteriorates with age, because it is not a self-sustaining            water, polycaprolactone quickly breaks apart, making it
machine. Over time, joints continuously wear away causing             unsuitable to build scaffolds on its own. However, the
immense pain and discomfort. For the past fifty years,                addition of hydroxyapatite, a naturally occurring mineral
arthritic patients have relied on artificial replacements to          form of calcium phosphate, improves polycaprolactone’s
heal their damaged joints. While a prosthetic initially cures         mechanical properties.      This combination has a lower
the joint, it has not proven to be a sustainable technology.          solubility than pure polycaprolactone alone, allowing it to



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                                                                                                                     Angela Beck
                                                                                                                 Shannon Gorman
stay intact in water. Therefore, the blend of polycaprolactone       to convince the public that the procedure is the solution to
and hydroxyapatite makes a valuable mixture perfect for              curing arthritis.
creating bioscaffolds [10].
   The “signal,” previously mentioned was provided by
growth factor TGFβ3 to encourage cells to build around the
bioscaffolds [8]. As the cell concentration begins to
multiply, the cells disperse to perform their specialized jobs
[9]. The majority of these cells become articular cartilage
cells that replace the damaged humeral head [8].

                     Promising Results

All together, the research done by Cook and Mao involved
the use of twenty-three rabbits. Ten rabbits received TGFβ3
infused bioscaffolds, ten received TGFβ3-free bioscaffolds
and three rabbits had the humeral head removed without
bioscaffold replacement. The researchers’ findings indicated
that three to four weeks after surgery, the hormone-free
rabbits limped with little use of the operated limb, and the                                    FIGURE 4
rabbits that received no bioscaffold limped at all times. In                        VARIOUS BIOSCAFFOLD IMAGES [1]
contrast, the rabbits in the hormone-infused group resumed
full weight-bearing movement. After five to eight weeks, the                        WHAT THE FUTURE HOLDS
hormone-infused rabbits showed continued improvement as
they moved with almost the same pace and flexibility as              So where do scientist go next? How do they go from
healthy rabbits of the same age. Four months following the           successes in rabbits and dogs to implementing this new
surgery, the hormone-infused bioscaffolds were completely            technology in humans? James Cook, the researcher from
covered with cartilage, while the hormone-free group had             Missouri University, commented on the matter. Cook stated,
only sparse cartilage formation and no cartilage formed in           “If we continue to prove the safety and efficacy of this
rabbits without bioscaffolds. The differences in cartilage           biological joint replacement strategy, then we can get FDA
formation are displayed in Figure 3. The first image shows a         approval for use of this technology for joint replacements in
bioscaffold lacking growth hormone, the second shows a               people. We are still in the early phases of this process, but
hormone-infused bioscaffold that had full tissue coverage,           this study gives a big boost to its feasibility” [3].
the third is a hormone-free scaffold that had only slight               After the FDA is satisfied with the performance of
tissue formation, and the fourth image shows the original            biological joint replacement in larger animals, Missouri
articular surface [8].                                               University plans to begin a year of safety trials in humans.
    Cook and Mao found that the entire surface of the joint          These trials will be used to prove the anticipated success of
regenerates without cell transportation. They concluded that         the new procedure in humans. During this time of
the only substance needed to perform the procedure was the           experimentation, the university will be the only place an
growth factor, which encouraged the host’s own cells to              individual can receive the new procedure. If this stage passes
develop into new bone and cartilage cells [11]. They also            all the safety trials, a clinical trial lasting five years or longer
discovered the scaffold had been repopulated by the rabbit’s         will begin. This trial will include an expensive and intensive
own cells, which appeared to come from stem or progenitor            study that will compare the outcomes of patients randomized
cells of the synovium cavity [8]. Cook and Mao did not               to either the biological procedure or artificial joint
come across any complications or unfavorable effects after           replacement. The researchers following each patient will not
the rabbits’ surgeries, because the new tissue performed to          know what surgery the patient underwent, therefore,
nearly its full original capacity [9].                               eliminating bias. The study will analyze the surgery’s
    Subsequently, Cook has performed the same exact                  outcomes, as the researchers will follow the patients through
technique used on the rabbits on two dogs, both of which             rehab and will assess their condition for four years after the
showed successful results. Without any complications, the            surgery.
dogs’ bodies accepted the implants, and the newly formed                 These extensive studies will prove biological joint
cartilage was replicative of healthy dog cartilage. Cook has         replacement is a better option than artificial joints. They will
identified an additional twenty-one dogs that will receive the       provide specific examples of the positive aspects of
procedure in the near future, in order to obtain more                biological joint replacement to the medical world to
promising results [11].                                              convince not only the FDA, but also the general public that
   This research done by Cook and Mao is necessary to                this procedure is the way of the future.
prove the effectiveness of biological joint replacement and


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                                                                                                                             Angela Beck
                                                                                                                         Shannon Gorman

  CONSIDERATION OF POTENTIAL DRAWBACKS                                 common complications of hip replacement surgery would be
                                                                       greatly reduced, and the number of patients who would need
Biological joint replacement cannot be performed on                    revision surgery would plunge.
humans without considering the potential drawbacks that                    Researcher James Cook stated, "The best a metal or
might not appear in the animal studies currently taking                plastic knee will ever be is when it is first placed inside the
place. Although other species have similar biological                  patient's leg. After that, it starts to deteriorate. The [joint]
processes, they are not identical. Furthermore, the                    that we are attempting to create would have the ability to
regenerative ability of some patients may be weaker                    adapt and 'learn' what to do in within the patient's body. It's
compared to others. For example, elderly patients with                 possible that the new [joint] will be better in ten years than it
chronic diseases such as diabetes would have a lower                   was when we first implanted it. This could have a lot of
regenerative capacity, making it harder for cells to regrow            implications for human [joint] replacements in the future”
the damaged articular cartilage.                                       [11]. Cook’s statement reinforces the importance of using
   Another problem is that the arthritic joint may not bear            biological joint replacement to heal arthritic joints. While
weight during the regenerative phase, leaving patients                 artificial replacements deteriorate over time, biological
handicapped for a considerable amount of time. Several                 replacements will continually improve the damaged joint.
weeks or even months could be needed for sufficient tissue                 There is a dire need to make the transition from
growth. In addition to healing time, the formation of the              biological joint replacement procedures in animals to
cartilage around the joint may require physical therapy to aid         humans as quickly as possible. The number of people in
movement and stimulation. The hip joint will essentially               need of hip replacements is consistently on the rise. If
have to relearn how to function after it is regrown, which             scientists and doctors want to fix the problems associated
may require extensive time and money [1]. Although                     with artificial joint replacement, actions must be made now.
biological joint replacement is not yet perfect, the                   In order to get the funding needed, the government must
advantages of the procedure greatly outweigh the                       realize the money invested in this research can save
disadvantages.                                                         hundreds of thousands of dollars sunk to fix artificial
                                                                       replacements of arthritic patients. Biological joint
                 Another Possible Solution                             replacement is the logical and ethical solution to aiding
                                                                       victims of arthritis, and the time has come to apply this
Some patients might see artificial joints as a faster and easier       procedure to humans.
solution than bioscaffold replacement. To overcome the
long, predicted regeneration time, scientists have proposed                                        REFERENCES
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                                                                                         Angela Beck
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                  ADDITIONAL RESOURCES

J. Hua, S. Muirhead-Allwood, N. Sandiford, J. Skinner. (2010, Feb 18).
“Metal on Metal Hip Resurfacing Versus Uncemented Custom Total
Replacement-Early Results.” Journal of Orthopedic Surgery and Research.
[Online Article]. Available: http://www.josr-online.com/content/5/1/8


                    ACKNOWLEDGEMENTS

There are many individuals whom we would like to thank
for helping us create this paper. First, we want to
acknowledge our professor, Dr. Meyers, for being our
primary educator of Engineering0012, and for helping us get
in contact with the right sources to create and modify this
paper. Next, we send special thanks to the writing center,
located on the third floor of the O’Hara Building. Without
their help, this paper would not express the same validity
and strength that it presents. We also would like to thank
Dr. Galle, Dr. Newborg, and Dr. Hamilton for taking time to
meet with us and answering any questions we had
concerning the assignment.        We also would like to
acknowledge our co-chair, Devon Albert. It was very
helpful to discuss our paper with her, especially since she
had already been through the process. Her feedback on our
topic choice and weekly suggestions of improvement were
very helpful in composing our conference paper.




                                                                                 7
        Angela Beck
    Shannon Gorman




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