Foot and Ankle Surgery 21 (2015) 108–112

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Foot and Ankle Surgery

journal homepage: www.elsevier.com/locate/fas

Use of Smart Toe implant for small toe arthrodesis: A smart concept?
Faiz Khan *, Shiori Kimura, Tayyab Ahmad, Darren D’Souza, Lester D’Souza
Regional Orthopaedic Hospital, Croom, Limerick, Ireland

A R T I C L E I N F O A B S T R A C T

Article history: Background: Arthrodesis of small joints for hammer and claw toe deformities is a common forefoot
Received 23 June 2014 operative procedure. Our objective was to review patients who underwent small toe arthrodesis with
Accepted 22 October 2014 Smart Toe intramedullary monobloc implant. Our aim was to assess patient’s surgical outcome and to
ascertain implant suitability.
Keywords: Methods: This procedure was undertaken in 90 patients from February 2011 to December 2012. We
ˆ
Smart ToeO present our review of 82 (91.1%) patients who attended the final six 6-month follow up. Mean age was
Forefoot surgery
56.5 years. There were 7 (8.5%) males and 75 (8.5%) males and 75 (91.5%) females. Clinical and
Hammer toe
Intramedullary digital implant
radiological evaluation was undertaken. A questionnaire was used to assess general symptoms, clinical
Small Toe arthrodesis outlook, deformity and patient’s perceptions and acceptance. Foot and Ankle Outcome Score and Foot
and Ankle Disability Index were used to judge outcome.
Results: There were 71 (86.6%) proximal and 11 (13.4%) distal interphalangeal joints with 69 (84.1%)
second, 7 (8.5%) third, 6 (84.1%) second, 7 (8.5%) third, 6 (7.3%) fourth toes. There was persistent swelling
in 7 (8.5%) and tenderness in 1 (1.2%). Appearance of toes was symmetrical in 71 (86.6%) and 11 (13.4%)
were asymmetrical but asymptomatic. The mean range of movement of the adjacent joint was 53.98.
Control of toes was good in 72 (87.8%) patients. Mean percentage of improvement was 76.1% with 100%
in 17 (20.7%) and over 80% in 47 (57.3%). Seventy (85.3%) would recommend and undergo repeat surgery.
There were 2 (2.4%) cases of metal cut out. There was one (1.2%) implant failure. Union was achieved in
79 (96.3%) patients.
Conclusion: We feel that Smart Toe small toe arthrodesis is a safe and reliable technique with good
patient outcome and acceptance.
 2014 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

1. Introduction important for good clinical outcomes to achieve a stable fixation

We present the largest series in literature of an intramedul-
lary implant for small toe arthrodesis. Surgery for small toe
arthrodesis whether undertaken in conjunction with another
foot procedure or in isolation is one of the most common foot and
ankle elective operative procedure. Multiple methods of fixation
of the arthrodesis have been and are being used [1–3]. None are
without associated issues that have a negative impact on surgical
outcome and patient satisfaction. There is much difference of
opinion in relation to treatment and a general consensus does not
exist as to one preferred method [4]. The most common method
is with the use of kirschner wires (k-wires). However, there is a
well known association of this technique with pin site infection,
non-union and wire migration [5]. This has lead to the use of
intramedullary devices for fixation of the arthrodesis [6]. It is
* Corresponding author. Tel.: +353 872345544.
E-mail address: fk166@yahoo.com (F. Khan).
and union [7]. We present our experience of Smart Toe1, an
intramedullary monobloc device for small toe arthrodesis. Our
aim was to determine its suitability as an implant for
intramedullary small toe arthrodesis in relation to surgical
outcome and patient acceptability and function. We also wished
to determine any issues related to its use, of the implant itself
and to enumerate any negative patient outcomes (Fig. 1).
2. Materials and methods
This prospective study was undertaken from February 2011 to
December 2012 at our elective orthopaedic institution. All
procedures were undertaken by the senior author with a special
interest in foot and ankle surgery. During this time, 90 consecu-
tive patients underwent the procedure. Of these, 82 (91.1%)
attended the final review and were considered for and included
in the study. The inclusion criteria were patients of either gender
with hammer or claw tow deformities of the lesser toes in
isolation or in conjunction with hallux valgus. All patients of

http://dx.doi.org/10.1016/j.fas.2014.10.003
1268-7731/ 2014 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
 F. Khan et al. / Foot and Ankle Surgery 21 (2015) 108–112
Fig. 1. Smart Toe1 implant. Neutral and 108 angled versions (Stryker foot and
ankle).
adult age were included. Exclusion criteria were a history of
previous surgery, rheumatoid arthritis and active local infection.
Patients were followed up in the elective outpatients and all were
reviewed by the senior and first author. The review was
undertaken at 2 weeks, 6 weeks and 6 months. A questionnaire
designed for this study was used for clinical review. This
reviewed any adverse symptoms experienced by the patient, the
presence of any clinical deformity and also the patient’s
perception and recommendation of the implant and the
procedure. The functional outcome was assessed with the Foot
and Ankle Outcome Score [8] and the Foot and Ankle Disability
Index [9,10]. Clinical review was accompanied by radiological
assessment to review union of the arthrodesis (Fig. 2).
Smart Toe is an intramedullary memory implant (MMI/Stryker
Corporation). It is made from Nitol which is an alloy consisting of
50% nickel and 50% titanium. It is available in two sizes which are
16 and 19 mm. There are two angles of the implant which are 08
and 108. It is a memory implant. It is stored in a fridge at 08 Celsius
temperature. It is taken from the fridge just before implantation.
Once inserted, it expands at body temperature leading to fixation
in the bone. This also leads to decrease in length of the implant
which leads to compression at the site of the osteotomy. As the
implant is flat, it resists rotation at the arthrodesis site. This results
in a stable fixation due to compression at the osteotomy thus
leading to good healing while minimising the chance of non-union.
The patients were admitted on the morning of their surgery and
spent the post-op night in the hospital. They were allowed
to mobilise and weight bear as tolerated on the first post op
day with the use of Barouk shoe [11] thus off loading the forefoot and
allowed home. The first follow up at the outpatients was at 2 weeks.
The sutures were removed, Barouk shoe was continued and
physiotherapy was commenced for the adjacent toes. The Barouk
shoe was discontinued at the 6-week visit. Patients were discharged
at the 6-month visit. Radiographs were taken at each visit.
The operative procedure consisted of an elliptical dorsal
incision over the affected joint. Osteotomy with excision of
the articular surfaces was done with an oscillating saw. A 2 mm
drill was used to make the entry points in each phalanx and
Fig. 2. The change in the shape of the implant from storage at 08 to post
implantation at 378. There is expansion of the implant with shortening (http://
de.memometal.com).
109
the rasp provided in the set was used for final preparation of
both surfaces. The implant was held in its holder, inserted
proximally and the distal toe reduced onto the implant and held
for thirty seconds until the implant expands and shortens to
provide stable fixation with compression [12]. The implant has to
be inserted within 60–90 s from the time it is removed from the
cold box.
3. Results
This prospective cohort study was undertaken from February
2011 to December 2012. A total of 90 patients underwent small
toe arthrodesis with the Smart Toe implant during this time. Of
these patients, 82 (91.1%) attended their follow up at 6 months
and were thus included in the study. There were 7 (8.5%) males
and 75 (91.5%) females. The average age was 56.5 years with a
range of 17–87 years. There were 43 (52.4%) left and 39 (47.6%)
right toes. The most common joint to undergo arthrodesis was
the proximal interphalangeal joint of the second toe. There were
71 (86.6%) proximal and 11 (13.4%) distal interphalangeal joints.
The second toe was operated on in 69 (84.1%) patients whereby 7
(8.5%) were third and 6 (7.3%) were fourth toes. Patients were
asked in the questionnaire to grade their improvement from 0 to
100%. The mean improvement in symptoms reported by the
patients was 76.1%. Seventeen (20.7%) patients reported 100%
improvement and 47 (57.3%) patients had greater than 80%
improvement in their symptoms. The detailed breakdown of the
improvement in symptoms is described in Table 1. Seven (8.5%)
patients had persistent swelling. One (1.2%) had local tenderness.
The toes were symmetrical in 71 (86.6%) patients. Eleven (13.4%)
operated toes were asymmetrical in comparison to the adjacent
toes but were asymptomatic and none of the patients were
unhappy with the overall cosmesis and look of the toes. One
(1.2%) patient was unhappy with the look of the scar. Two (2.4%)
patients had problems with wearing high heels but were
comfortable in general footwear. There was one (1.2%) case of
superficial infection that was successfully treated with a five-day
course of oral flucloxacillin with complete resolution. The mean
range of movement at the adjacent joint was 53.98. Seventy two
(87.8%) had good control over their toes. The surgery would be
recommended by 70 (85.3%) patients who would be happy to
undergo a repeat procedure. There were 2 (2.4%) cases of metal
cut out and union was achieved in 79 (96.3%) patients. There was
one (1.2%) implant failure.
Table 1
Detailed analysis of the improvement in symptoms at 6 months of the patients and
their relative percentages.
110 F. Khan et al. / Foot and Ankle Surgery 21 (2015) 108–112
Table 2
Foot and Ankle Disability Index. The graph shows that 92.7% patients scored from 70
to 100.
The Foot and Ankle Disability Index was scored at the 6-month
visit. It evaluated the general outcome post surgery in relation to
general daily activities, walking, pain and work. The score was over
90 in 67.8% and from 81 to 90 in 17.8% and was 70–100 in 92.7%
patients (Table 2).
The Foot and Ankle Outcome Score was also used to evaluate
function post surgery and was assessed at the 6-month visit. It
evaluated in detail five parameters including general symptoms,
pain, activities of daily living, function related to sports and
recreation and quality of life. These aspects were reviewed in
relation to the last week prior to the assessment. The results for
each parameter are normalised and presented separately. The
score was over 90 for 67.8%, 71.4%, 82.1%, 69.6%, 73.2% respectively
for each of the five parameters enumerated above and 81–90 for a
further 19.6%, 16.0%, 12.5%, 14.2%, 10.7%. Hence both scores
demonstrated a strongly positive outcome for the multiple factors
assessed (Table 3).
Table 3
Foot and Ankle Outcome Score. The five evaluated parameters are general
symptoms, pain, activities of daily living, function related to sports and recreation
and quality of life. The score was over 90 for 67.8%, 71.4%, 82.1%, 69.6%, 73.2%
respectively for the five parameters. A strong positive outcome for all factors is seen.
4. Discussion
Arthrodesis of the small toes is one of the most common
forefoot surgical procedure and is used to ensure that a permanent
correction of hammer and claw toe deformities is obtained
[13,14]. It may be carried out in isolation or may be undertaken
in conjunction with other procedures as hallux valgus surgery.
Various methods of fixation of the arthrodesis are in vogue at
present [15–17]. The most common method is the use of kirschner
wires [13,14]. However, there is a known incidence of non-union,
pin site infection, wire migration, wire breakage and wire removal
[13]. No compression is achieved at the site of the arthrodesis.
There is no control over rotation. The end of the k-wire is proud of
the skin and patients often find it awkward to manage and are
concerned about infection and accidentally pulling it out. In some
studies, the k-wires were buried under the skin but a high rate of
wire removal of 33% at revision surgery has also been reported as
over time, the wire protruded through the skin [18]. Various
techniques have been used to circumvent these issues. One is the
use of intramedullary compression screws. The screw head
however may be prominent and cause discomfort necessitating
removal [19]. Absorbable intramedullary pins have also been used
with some success but issues with floating toe, mallet toe, and
broken implants have been documented [15]. We present our
experience with the use of the Smart Toe implant. It is a monobloc
implant and thus avoids a potential weak point of implants that are
in two parts and are fixed or hinged at a central point [20]. The
satisfaction rate with the surgery was high as was the number of
patients who would recommend the surgery. The overall
improvement of symptoms was significant. One patient was not
satisfied with the look of the scar. She felt that the scar was too
prominent across her toe but did not have any functional issues
and was satisfied with the appearance of the toe. Swelling was an
issue with seven patients. It was minimal at rest but was worse
during the course of the day and leading to an aching sensation in
three patients and feeling of fullness in four patients. Footwear was
reported as a problem by two patients. They were uncomfortable
when using high heels but had no problems when using flat shoes
or low heels. The toes were symmetrical in 86.6% patients. Even
though there was asymmetry in 13.4% patients, it was of mild
degree and none of the patients reported any problems in relation
to the function of the toes or that of the foot. One patient had
ongoing tenderness and was very dissatisfied with her outcome.
One patient developed superficial cellulitis that was treated with
oral flucloxacillin for five days with complete resolution and no
Fig. 3. Failure of Smart Toe implant.
 F. Khan et al. / Foot and Ankle Surgery 21 (2015) 108–112
Fig. 4. (a) AP view with the Smart Toe1 implant in satisfactory position. (b) AP view
showing proximal migration of the implant in the proximal phalanx. (c) Lateral
view of Smart Toe1 implant showing the loss of position of the arthrodesis due to
proximal implant displacement.
long term issues. There was one incidence of implant failure. The
patient was a 59-year-old female. She did not have any symptoms
and thus declined to undergo a revision procedure. She remained
asymptomatic at her 6-month follow up (Fig. 3).
Much higher rates of implant failure have been recently
reported [21]. The reason for this significant difference is unclear.
All patients in our study were mobilised in a Barouk shoe thus off
loading the forefoot by 79–96% mean peak pressure [22] thereby
preventing any significant weight transfer across the arthrodesis
and thus the implant. This would allow the arthrodesis to heal and
win the race with metal fatigue and failure. There were two cases
of implant cut out. All cut outs were distal and in the dorsal
direction. The first patient was a 56-year-old female and the
second was a 49-year-old female. Neither of the two patients was
diabetic. The implant was seen to have cut out of the distal
fragment at the 2-week review of the two patients. Both patients
underwent revision surgery. The implant was removed and
111
Fig. 5. Guide for resection and implant placement (http://ukmemometal.com).
fixation was done with kirschner wires. Both patients eventually
united, albeit at 8 and 10 weeks (Fig. 4).
As per operative recommendation, it is suggested that two
thirds of the implant should be in the proximal segment and one
third should be in the distal segment (Fig. 5).
This was not the case in these two patients. Ideally, the implant
is inserted into the proximal segment up to the holder which is at
the waist of the implant. However, the implant may migrate
proximally as the distal segment is reduced onto the implant [21].
This may be secondary to poor operative technique or osteoporotic
bone. Over reaming of the proximal segment would lead to poor
fixation of the implant leaving the possibility of it being
inadvertently pushed in further than is optimum during reduction.
Under reaming of the distal segment may have the same effect of
pushing the implant more proximal than its desired position.
Strong emphasis must be placed on the need of adequate implant
placement.
The implants must be stored in a frozen state and are retrieved
just prior to insertion. This at times provided to be a logistical issue.
Once removed from cold storage, the implant has to be inserted
within 60–90 s. A further shortcoming of the system was the non-
availability of trials or templates for the implants. Thus it is
imperative to have everything in place before hand as this does not
allow for any revisions to the osteotomy or change to the implant
size or angle. The design of the implant does lead to compression at
the site of the osteotomy and controls rotation due to its flat design
thus leading to a good union rate.
The use of intramedullary implants for small toe arthrodesis
with the Smart Toe implant had good results with regard to fusion
of the arthrodesis and patient satisfaction. The study is limited as
there was no direct comparison with kirschner wire group. Some
issues associated with the implant and the surgical technique are
highlighted. We believe it to be a safe and stable implant with
reproducible results.
Conflict of interest
There was no conflict of interest. No monetary or any other
benefit was received by any author or the institution.
References
[1] Moon JL, Kihm CA, Perez DA, Dowling LB, Alder DC. Digital arthrodesis: current
fixation techniques. Clin Podiatr Med Surg 2011;28(August (4)):769–83.
[2] Asirvatham R, Rooney RJ, Watts HG. Stabilization of the interphalangeal joint
of the big toe: comparison of three methods. Foot Ankle Clin 1992;13(May
(4)):181–7.
[3] Yu GV, Vincent AL, Khoury WE, Schinke TL. Techniques of digital arthrodesis:
revisiting the old and discovering the new. Clin Podiatr Med Surg 2004;21(Jan-
uary (1)):S0–17.
112 F. Khan et al. / Foot and Ankle Surgery 21 (2015) 108–112
[4] Schrier JC, Louwerens JW, Verheyen CC. Opinions on lesser toe deformities
among Dutch orthopaedic departments. Foot Ankle Int 2007;28(12):1265–70.
[5] Witt BL, Hyer CF. Treatment of hammertoe deformity using a one-piece
intramedullary device: a case series. J Foot Ankle Surg 2012;51(July–August
(4)):450–6.
[6] Ellington JK. Hammertoes and clawtoes: proximal interphalangeal joint cor-
rection. Foot Ankle Clin 2011;16(December (4)):547–58.
[7] Edwards WH, Beischer AD. Interphalangeal joint arthrodesis of the lesser toes.
Foot Ankle Clin 2002;7(March (1)):43–8.
[8] Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome
score for ankle ligament reconstruction. Foot Ankle Int 2001;22(October
(10)):788–94.
[9] Martin RL, Burdett RG, Irrgang JJ. Development of the Foot and Ankle Disability
Index (FADI). J Orthop Sports Phys Ther 1999;29:A32–3.
[10] Hale S, Hertel J. Reliability and sensitivity of the foot and ankle disability index
in subjects with chronic ankle instability. J Athl Train 2005;40(January–March
(1)):35–40.
[11] Barouk LS. Re: the use of post-operative reverse camber shoes following scarf
osteotomy. Foot Ankle Surg 2008;14:190–3.
[12] Smart Toe Intramedullary Memory Implant. Surgical Technique. MMI-USA
Foot and Ankle.
[13] McGlamry ED, Jimenez AL, Green DR. Lesser ray deformities: deformities of the
intermediate digits and metatarsophalangeal joint. In: Banks AS, Downey MS,
Martin DE, Miller SJ, McGlamry ED, editors. McGlamry’s comprehensive
textbook of foot and ankle surgery. Philadelphia: Lippincott Williams &
Wilkins; 2001.
[14] Kitaoka HB, Richardson EG. Realignment of lesser toe deformities. In: Kitaoka
HB, editor. Master techniques in orthopaedic surgery: the foot and ankle.
Philadelphia: Lippincott Williams & Wilkins; 2002. p. 150–5.
[15] Konkel K, Menger A, Retzlaff SA. Hammer toe correction using an absorbable
intramedullary pin. Foot Ankle Int 2007;28:916–20.
[16] Lane G. Lesser digital fusion with a cannulated screw. J Foot Ankle Surg
2005;44:172–3.
[17] Mereau M, Ford T. Nitinol compression staples for bone fixation in foot
surgery. J Am Podiatr Med Assoc 2006;96:102–6.
[18] Creighton R, Blustein S. Buried kirschner wire fixation in digital fusion. J Foot
Ankle Surg 1995;34:567–9.
[19] Caterini R, Farsetti P, Tarantino U, Potenza V, Ippolito E. Arthrodesis of the toe
joints with an intramedullary cannulated screw for correction of hammertoe
deformity. Foot Ankle Int 2004;25:256–61.
[20] Briggs L. Proximal interphalangeal joint arthrodesis using the StayFuse im-
plant. Tech Foot Ankle Surg 2004;3:77–84.
[21] Scholl A, McCarty J, Scholl D, Mar A. Smart Toe implant versus buried kirschner
wire for proximal interphalangeal joint arthrodesis: a comparative study. J
Foot Ankle Surg 2013;52:580–3.
[22] Deleu PA, Leemrijse T, Vandeleene B, Maldague P, Devos Bevernage B. Plantar
pressure relief using a forefoot offloading shoe. Foot Ankle Surg 2010;16(De-
cember (4)):178–82.