FUTURA PRIMUS FLEXIBLE

GREAT TOE

NAME OF THE TEAM

MEMBERS
1. HEATHER BATESON ()
2. JOSH HASTINGS ()
3. JOSHUA SABERY ()
4. MOHAMMAD NASFIKUR RAHMAN
KHAN (140587243)

Newcastle University
Bioengineering [MEC3013]

Contents
Prosthesis.............................................................................................................. 2
Anatomy................................................................................................................ 3
Loads and Motions................................................................................................. 4
Comparisions to alternative impacts..................................................................... 5
Benefits and Drawbacks of the Prostheses............................................................ 7
Regulatory and Quality Control Issues................................................................... 7
Clinical and Laboratory based treatments and results ........................................... 9
Conclusion........................................................................................................... 10
References:.......................................................................................................... 11

Table of figures
Figure 1: Image of the Primus flexible great toe joint replacement[4]................................. 2
Figure 2 Table showing different dimensions available that are manufactured for the Primus
flexible great toe joint replacement[4, 11]...................................................................... 2
Figure 3 Schematic image anatomy of the great toe joint with parts labelled[6]................... 3
Figure 4 Photograph (Screen Shot) of the great big toe joint during surgery[8]...................3
Figure 5 X-Rays showing a normal first MTP joint[1, 12]................................................. 4
Figure 6 X-ray showing first MTP joint with arthritis [10, 12]............................................ 4
Figure 7 showing the various angles of the foot during propulsion.[7]................................ 5
Figure 8 Image showing the BioPro First MPJ Hemi Implant[2]........................................ 5
Figure 9 X-Ray showing a BioPro product implanted in a foot[2]...................................... 5
Figure 10 Swanson design, silicon double-stemmed, hinged implant[3]............................. 6
Figure 11 Shows the LaPorta implant with a 15 degree angle to duplicate the natural
declination angle.[9, 10]............................................................................................. 6
Figure 12 showing the Surgery invasive Long-term use and implantable devices[9, 10].......8
Figure 13 table Showing the class IIb medical devices routes to CE marking[5]...............8
Figure 14 Implants grad via AOFAS scale[1]................................................................. 9

Flexible Primus Great Toe

Futura Primus Flexible Great

Toe
Prosthesis
To achieve a total great toe joint replacement a double stemmed implant is used, the first of
its kind, made from a silicone elastomer with a flexible hinge connecting the two
stems. The purpose of the replacement is to replace any missing or damaged
cartilage in the joint where the great toe meets the foot. The two silicon
parts glide easily against one and other allowing the toe to move. This
practice is most frequently used to treat a problem called stiff big toe or
Hallux Rigidus. This leads on from Hallux Limitus where the
movement and motion of your great toe decreases over time
causing the carriage in the joint becoming eroded. This specific
implant
is called The future Primus Flexible Great Toe of FGF. It
was
designed using computer modelling to allow multiple designs
to be compared. This
design has progressed through generations, this being the
third. The design has been tested and improved giving an
Figure 1: Image of the Primus
optimum design with more advanced materials and
techniques. [13, 14]
One of the greatest challenges when designing a joint replacement is what material to use.
Ideal characteristics of a material would be durability, resistance to deformity and the ability
to replicate the body material that it replacing. This model is made from ULTRASIL medical
grade silicone elastomer and includes titanium grommets. Titanium has been used in
surgery since the 1950s and is still being used today in all parts of the body, due its
biocompatibility. It is considered the most biocompatible of all metals because it can survive
attacks from bodily fluids, it is compatible with bone growth and remains flexible and strong
during its time in the body.

Figure 2 Table showing different dimensions available that are manufactured

Flexible Primus Great Toe

Anatomy
The Futura primus flexible great toe implant has been designed by Tornier for fundamental
usage in a first metatarsophalangeal joint arthroplasty [1]. Therefore the joint of concern
when identifying the key bones, muscles and ligaments is the first metatarsophalangeal joint,
the word first indicates that it is referring to the metatarsophalangeal joint of the great toe as
opposed to any of the other lesser toes within the foot. The fundamental bones that connect
to either side of the joint are the first metatarsal and the proximal phalanx as can be seen in
Fig.1, a rotary burr is used during the arthroplasty operation to create the correct shaped
slots in the aforementioned bones in order for the primus implant to be fitted [Fig.2]. The
head of the first metatarsal bone is convex shaped while the end of the proximal phalanx
that it is joined to is concave allowing seamless articulation. Stability of the first MTP is
provided by the capsuloligamentous-sesamoid complex in conjunction with the
aforementioned bones. This joint capsule consists of a number of different ligaments, the
medial and lateral sesamoid ligaments, which can be sub-divided into the
phalangeosesamoid or metatarsosesamoid medial and lateral ligaments. The function of
these ligaments is to join both the First metatarsal and the proximal phalanx to both the
medial and lateral sesamoids within the joint capsule. A sesamoid is a bone that is
embedded within a tendon, and in this case the sesamoids reside inside the tendons of the
flexor hallucis brevis muscle. Another important ligament is the intersesamoid ligament, this
simply keeps the two sesamoids from being pulled apart within the joint capsule. Also within
the joint capsule exists the plantar plate which is a fibrocartilaginous structure joining the
proximal phalanx to the neck of the metatarsal, it plays an important part in supporting the
weight of the body, distributing this weight and restricting dorsiflexion. The muscles within
the hallux (great toe) are also vital, the flexor hallucis longus muscle via the flexor hallucis
longus tendon as well as the flexor hallucis brevis muscle provide the flexion movement of
the hallux. The abductor and adductor hallucis muscles provide the extension movement of
the hallux.

Figure 3 Schematic image anatomy of the great toe

Figure 4 Photograph (Screen Shot) of the great big toe joint
during surgery[8]

Flexible Primus Great Toe

Figure 5 X-Rays showing a normal first MTP

joint[1, 12]

Figure 6 X-ray showing first MTP joint with

arthritis [10, 12]

Loads and Motions

The function of the toes is to assist whilst walking, to provide balance, to bear weight and to
aid in propulsion during gait. The Largest of these joints capable of these actions is the first
metatarsophalangeal articulation. The normal range of motion in a healthy joint is 70 of
dorsiflexion which is the extension of the foot towards the shin and 45 of plantar flexion,
which is the flexion of the foot whilst on your toes. The joint is also able to abduct and adduct
from the midsagittal plane of the foot.[13, 15]
The Primus Flexible Great toe can hinge up to 95 on its axis without the Titanium grommets
from coming into contact with each other. The proximal stem is also angled at 15 upward
from the hallux to align with the natural form of the body. This angled adjustment improves
the biomechanics from existing metatarsophalangeal joints and reduces stress placed upon
the implant.[4]
During normal gait the metatarsophalangeal joint bears between 40- 60% of the persons
weight. This load on the body occurs at the metatarsal heads. To do this the joint must
continuously remain in contact with the ground from the transition of the foot from heel to toe
propulsion. The load that a normal joint is capable of withstanding can be up to three times
the persons entire body weight in activities such as running.[9, 12]
The Primus Flexible joints double stemmed deigned has provided more transverse plane
stability then competing joints, however a negative advantage of fixing the axis of rotation
solely on the implant was an increased dorsiflexion range which increased stress at the stem
hinge interface.[4]
Clinical research following these operations has found that the weight bearing on the 1 st and
2nd metatarsals changes drastically compared with a normal joint. During normal gait there
was an average increase of 65% placed on the 2 nd metatarsal and a decrease of 43% on the
hallux which resulted in a high number of fractures on the second metatarsal.[9]
The transition from heel to toe is achieved by the 1 st metatarsal pivoting against the proximal
phalanx of the Hallux by 20. The metatarsal head must then slide over the articulating
surface of the proximal phalanx towards toe propulsion.[7]

Flexible Primus Great Toe

6
Figure 7 showing the various angles of the foot during propulsion.[7]

Comparisions to alternative impacts

The hemi-implant which was first introduced in 1967 and was initially very popular, but today
it is infrequently used at all. Instead of two stems, like the Primus, a hemi-implant only has
one stem implanted. Several companies produce hemi-implants, however years of
experience has shown that the life span on these implants are relatively short and have
caused a considerable amount of complications. The BioPro First MPJ Hemi Implant boasts
that the hemi implant is simple to implant and removes the minimum amount of bone
possible.

Figure 8 Image showing the BioPro

Figure 9 X-Ray showing a BioPro product implanted in a

The double-stem total implant was introduced in 1974 by Swanson. It is extremely similar to
the Futura Primus implant. Both are made from Silicone Elastomer and both use titanium
grommets. The Swanson was originally not a brand new design, but a modification of a hand
implant, just with thicker stems.

Figure 10 Swanson design, silicon double-stemmed, hinged implant[3]

The Lawrence and LaPorta Implants were released in 1982. They were designed to offer
improved function and movement. Their tapered stems are angled at 15 degrees to replicate
the declination angle of the first metatarsal.
Flexible Primus Great Toe

Figure 11 Shows the LaPorta implant with a 15 degree angle to

Futura Biomedical were the first to use UltraSIL silicone elastomer for its implants in 1997.
This material was very advanced compared to previous materials used by its
competitors.The Futura Primus Flexible Great Toe, like the Lawrence and LaPorta implants,
has an angled proximal stem to correspond with the natural metatarsal declination angle.
The hinge is highly engineered to offer a 95 degree range of motion, which is greater than
the natural motion of this joint.

Benefits and Drawbacks of the Prostheses

As with all Implants there are positives and negatives when compared to other similarly
functioning implants and the natural joint. Currently there are no joint replacements out there
that are as good as or better than the natural joint but they are vast improvements over
diseased or destroyed joints.
The Primus Flexible great toe joint is produced from a fourth generation Silicon Polymer,
when compared to previous silicon joints it has much improved properties. It has a higher
tensile strength and greater resistance to tearing and wear.
The main reasons for the use of implants is to give the receiver a greater degree of pain free
motion and to improve the cosmetics of the deformed toe caused by Hallux valgus. The
Primus Flexible provides 95 degrees of motion which is within the normal range of a fully
operating joint of 90 to 120 degrees of motion and due to its axial offset by 10 degrees the
stress on the prosthesis is reduced which improves biomechanical function.[9]
Compared with other similar implants the Primus has a trapezoid stem cross section the
same as the anatomy of the intramedullary canal and only simple instrumentation is needed
to fit the implant.[16]
However there are many drawbacks to Silicon being placed in the body the main one being
Silicon synovitis, the inflammation of the joint tissue caused by the micro silicon particles
being dissociated from the implant. Characteristics of this occurrence is pain within the joint
when in motion, a severe loss of motion, implant fracture, subluxation and the worst being
Flexible Primus Great Toe

8
the destruction of bones due to the growth of Osteoplastic giant cells entering the bone at
the implant site causing a structural weakness.[9, 17]
The Primus Flexible isnt comparable with a natural joint as it doesnt cope well with
compressive and shear forces, therefore is not suitable for younger active patients who will
apply greater forces to the prosthetic

Regulatory and Quality Control Issues

It is important to note that there is not a single internationally recognized regulatory body for
the quality control and regulation of medical devices and implants, different regions of the
globe have different governing bodies (Americas regulatory body for medical devices is
encompassed by the FDA [Food and Drug Administration]). Tornier is an internationally
recognized company that sells products to over forty-five countries, for Tornier to be able to
sell its products and gain the CE mark (without which they cannot be commercialized) in the
EEA (European economic area) they must comply with the contents of the EU Medical
Devices Directives [1]. The UK is part of the EEA. Therefore for the Futura primus flexible
great toe implant to be sold in the UK it must undergo a conformity assessment procedure
created and implemented by the European commission. A fundamental part of the procedure
is the assessment of the product in question by a notified body. A notified body is a
certification organization that has been deemed as competent and capable by the national
authority (Within the EU a notified body is selected by the state for that state alone) for
carrying out the various aspects of the conformity assessment procedure. The UKs notified
body is the MHRA (The Medicines and Healthcare Products Regulatory Agency). The
intervention of a notified body depends on the class of the medical device, through the use
of Fig i made by the European commission it can be seen that the prostheses assigned for
this report can be classified as IIb. Therefore Tornier must follow the flow diagram in Fig ii in
order to be able to distribute its product in the UK, however the manufacturer does have two
options for the procedure. These options include either a full quality insurance audit by the
MHRA indicated in Annex II, or a type examination indicated in annex III plus any one of the
fourth, fifth or sixth annexes.

Figure 12 showing the Surgery invasive Long-term use and implantable devices[9, 10]

Flexible Primus Great Toe

Figure 13 table Showing the class IIb medical devices routes to CE marking[5]

Flexible Primus Great Toe

10

Clinical and Laboratory based treatments and results

There are a vast array of 1st MTP joint implants on the market, so it would follow that there
are a variety of different clinical and laboratory test results available to analyse. The
following results specifically relate to the primus first MTP joint double-stemmed silicone
implant.[18] A link was found on the NCBI (national centre for biotechnology information)
website containing post-operative analysis details on the aforementioned implant. A total of
144 patients were invited to participate, and between them they represented 201 implants
(57 patients had both of their 1st MTP joints replaced). The post-operative analysis period
ranged between 32 and 108 months with an average of 66.4 months. However only 54
patients representing 70 implants responded to the invitation (the low participation rate is
possibly indicative of patient satisfaction). The study that the patients were subject to
consisted of the following: Visual Analogue Scale, Foot and Ankle (VAS FA) patient outcome
and satisfaction questionnaire, clinical examination, and X-ray evaluation. Because of the
nature of the analysis, the scale created by the AOFAS (American Orthopaedic Foot and
Ankle Society) is a mixture of both subjective and objective categories, the nature of the
scaling criteria reflects this (Fig.?). The Scale is split into 3 categories, pain, function, and
alignment. At the heart of the subjective criteria lies the pain section for obvious reasons
(only means of giving a value to the pain is down to the patients judgement) whilst function
and alignment are more or less purely objective. Patients with hallux rigidus had an average
post-operative AOFAS scale score of 88.2, whilst those with hallux valgus with arthritis had
an average score of 88.6 (Max score for these scales as can be seen in Fig.? is 100)
therefore these scores show a relatively high level of patient satisfaction with their Tornier
Primus great toe implants as the closer the score is to 100 the more positive the results have
been. It can also be noted that the average VAS patient satisfaction for the patients was 8.5
(with 10 being highest satisfaction) further indicative of an implant that has been successful.
[19]

Figure 14 Implants grad via AOFAS scale[1]

Flexible Primus Great Toe

11

Conclusion
There are many different types of implant available for the replacement of the Great Toe
Joint. They have progressed through 3 generations of adaptations and improvements. They
vary from single stemmed implants, double stemmed, tapered and angled.
The Futura Primus Implant offers one of the most advanced of these designs, combining
ULTRASIL medical grade silicone elastomer with titanium, one of the most bio compatible
materials. It's tapered, angled stems allow a more natural metatarsal declination angle.

Flexible Primus Great Toe

12

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17.
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Flexible Primus Great Toe