BACKGROUND: A locked nail is the principal method used to eliminate rotatory components in femoral and tibial fractures. Nevertheless, weight bearing is not directed onto the fracture site, slowing down the healing process; another possibility is to use a large-diameter nail and ream the canal to obtain as much adherence as possible and increase the grip, but this can cause a number of complications. The expandable nail is a new option that in theory should remove some problems with previous techniques. MATERIALS AND METHODS: This was a retrospective nonrandomized study encompassing 21 femoral fractures and 27 tibial fractures in 45 patients. They were classified according to the AO classification. Clinical and radiological checks were done at one, three, and six months and at one year from the surgery in order to check for signs of clinical and radiological healing. A good alignment was considered to be the presence of a deformity of less than 5° in the sagittal and lateral planes and the absence of rotatory clinically evident problems. This protocol was adhered to up to six months after surgery by all of the patients, while only 62.2% performed the last control. The mean follow-up was 15 months. A second group of 48 consecutive fractures (24 femural and 24 tibial) treated with locked nail was created to compare surgical times. RESULTS: Appropriate alignment was observed in all cases; the healing process appeared slower: radiological healing occurred in most cases at six months. The following complications were reported: a case of intraoperative fracture widening with no effect on the treatment; a case of a lesion of the tip of the nail with pneumatic system rupture that necessitated nail substitution; two cases of retarded consolidation at six months, with both tibial fractures treated successfully by intralesion platelet gel; a case of incarcerated nail on 17 removals, resolved by shearing. We had no cases of clinically evident compartment syndrome or pulmonary embolism. CONCLUSIONS: The expandable Fixion nail presents significant advantages in the treatment of transverse and short oblique fractures of femur and tibia because it is easy to use, involves minimal X-ray exposure and can control rotations. Nevertheless, it high cost limits its use. We consider it as an alternative to locked nail

Alessandro Ranalletta

Alexander Di Francesco

Carmine Zoccali

Stefano Flamini

Journal of Orthopaedics and Traumatology

PubMed

Springer - Publisher Connector

ORIGINAL ARTICLE
Clinical and radiological midterm results from using
the Fixion expandable intramedullary nail in transverse
and short oblique fractures of femur and tibia
Carmine Zoccali Æ Alexander Di Francesco Æ
Alessandro Ranalletta Æ Stefano Flamini
Received: 15 September 2007 / Accepted: 27 May 2008 / Published online: 2 August 2008
 Springer-Verlag 2008
Abstract
Background A locked nail is the principal method used to
eliminate rotatory components in femoral and tibial frac-
tures. Nevertheless, weight bearing is not directed onto the
fracture site, slowing down the healing process; another
possibility is to use a large-diameter nail and ream the
canal to obtain as much adherence as possible and increase
the grip, but this can cause a number of complications. The
expandable nail is a new option that in theory should
remove some problems with previous techniques.
Materials and methods This was a retrospective nonran-
domized study encompassing 21 femoral fractures and 27
tibial fractures in 45 patients. They were classified
according to the AO classification. Clinical and radiologi-
cal checks were done at one, three, and six months and at
one year from the surgery in order to check for signs of
clinical and radiological healing. A good alignment was
considered to be the presence of a deformity of less than 5
in the sagittal and lateral planes and the absence of rotatory
clinically evident problems. This protocol was adhered to
up to six months after surgery by all of the patients, while
only 62.2% performed the last control. The mean follow-up
was 15 months. A second group of 48 consecutive frac-
tures (24 femural and 24 tibial) treated with locked nail was
created to compare surgical times.
Results Appropriate alignment was observed in all cases;
the healing process appeared slower: radiological healing
occurred in most cases at six months. The following
complications were reported: a case of intraoperative
fracture widening with no effect on the treatment; a case of
a lesion of the tip of the nail with pneumatic system rupture
that necessitated nail substitution; two cases of retarded
consolidation at six months, with both tibial fractures
treated successfully by intralesion platelet gel; a case of
incarcerated nail on 17 removals, resolved by shearing. We
had no cases of clinically evident compartment syndrome
or pulmonary embolism.
Conclusions The expandable Fixion nail presents signif-
icant advantages in the treatment of transverse and short
oblique fractures of femur and tibia because it is easy to
use, involves minimal X-ray exposure and can control
rotations. Nevertheless, it high cost limits its use. We
consider it as an alternative to locked nail.
Keywords Fixion nail  Expandable nail 
Trasverse fracture osteosynthesis
Introduction
The system used in osteosynthesis directly influences
fracture consolidation; depending on its shape and rigidity,
osteosyntesis is capable of modifying bone callus forma-
tion. The intramedullary nail is currently the primary
treatment for closed diaphyseal fractures and for grade I
and II open lesions according to the Gustilo and Anderson
C. Zoccali  A. Di Francesco  A. Ranalletta  S. Flamini
‘‘S. Salvatore’’ Regional Hospital of L’Aquila,
L’Aquila (AQ), Italy
C. Zoccali
Oncological Orthopaedics Department,
Muscular-Skeletal Tissue Bank IFO-IRE, Rome, Italy
C. Zoccali (&)
Universita` degli Studi dell’Aquila, Via Vetoio, 1,
67100 L’Aquila, Italy
e-mail: carminezoccali@libero.it
A. Ranalletta
University of L’Aquila, L’Aquila, Italy
123
J Orthopaed Traumatol (2008) 9:123–128
DOI 10.1007/s10195-008-0018-2
classification [1, 2]. This technique safeguards limb length
and the soft tissue around the bone fragments. The
immediate weight bearing allows gravity to act directly on
the fracture site, encouraging bone callus formation.
Although the intramedullary nail is able to control dis-
location and banding ‘‘ad latum,’’ it is not able to control
rotation [3]. Locking with proximal and distal screws
impedes rotation so that it may be applied to metaphyseal
fractures. However, this takes the weight off the fracture
site, slowing down the healing process. Due to deformation
of the nail during its insertion into the canal, the external
guide may be not exact, forcing the surgeon to operate with
excessive use of an X-ray image intensifier.
The use of a large-diameter nail is another possibility that
should eliminate rotation and increase stability [4]. This
involves reaming the canal. It has been reported that this
action can cause numerous complications, such as intra-
medullary circulation injuries, a rise in local temperature,
and increased risk of embolism and infection, although this
is not in accordance with the literature [5, 6]. One way to
circumvent this problem could be to use the Fixion
expandable intramedullary nail (DISC-O-Teck, Herzliya,
Israel). The diameter of this nail can be increased by 75% by
introducing physiological solution inside it with a manual
pump. In section, the expanded nail is characterized by four
rods that penetrate the diaphyseal spongiosa. Its use
removes the need for locking screws, and reaming becomes
optional. Recent literature has emphasized the advantages
of this technology for the surgeon (its ease of use) and for
the patient (its good stabilization, and a healing rate of
between 95 and 100%) [7–16]. The aim of our study was to
evaluate the use of this expandable intramedullary nail,
focusing on indications, advantages, problems and midterm
results from its application to femoral and tibial fractures.
Materials and methods
All cases of lower limb fractures observed in a regional
general hospital from January 2003 to December 2005 that
were treated with the Fixion expandable intramedullary
stabilization system were evaluated. This cohort consisted
of a consecutive series of operations performed by the
senior author (S.F.). Inclusion criteria were femoral con-
secutive fractures classified according to the AO
classification as A2, A3, B1, B2 and tibial consecutive
fractures of types A2, A3, B2 and B3 [17]. Other treatments
were performed for long oblique and comminuted fractures,
and for Gustilo and Anderson type II and III fractures.
The cases were classified as follows: 45 patients (aged
from 17 to 58 years, mean 35), 48 inferior limb fractures,
of which 21 were femoral fractures and 27 tibial fractures;
three patients had been treated for both femoral fracture
and tibial fracture. Our fracture series was distributed as
follows: 11 fractures of type A2, three fractures of type A3,
three fractures of type B1 and two of type B2. Our tibial
fracture series was distributed as follows: seven fractures of
type A2, 16 fractures of type A3, one fracture of type B2
and three of type B3.
We observed only one case of Gustilo and Anderson
type I open fracture. All operations had been performed
within 72 h of the trauma. Short-term antibiotic prophy-
laxis with cephalosporins was carried out; in cases with a
high risk of infection, teicoplanin (400 mg) was added.
Prevention of deep-vein thrombosis was achieved with
low-molecular weight heparin, starting at the moment of
trauma and continuing for three weeks or until the patient
had regained adequate ambulation.
The nail was introduced via trochanteric access for
femoral fractures and by transpatellar tendon for tibial
fracture; in four cases the medullary canal was reamed.
Nail length was determined using a metallic rule and an X-
ray image intensifier.
Post-operative management: in the first post-operative
day, active and passive physiotherapy of the neighboring
joints was initiated without the use of a tutor to maintain
muscular tone. Weight bearing was permitted on the sec-
ond post-operative day using two crutches or a Zimmer
frame; partially at first, and then progressively starting
from ten days after surgery. X-ray controls were performed
at one, three and six months after surgery for all patients,
and at one year for 28 patients because of most of them
lived too far away. The mean follow-up was 15 months.
Nails were removed at one year if possible; later removal
is very difficult because of bone integration, so that attempts
were only made after one year in young people. A second
control group was created by selecting 48 consecutive
patients previously treated with conventional locked nails
for similar types of femoral and tibial fractures. This second
group was similar to the first one in terms of demographic
distribution (age 23–62 years, mean 37) and fracture type. It
consisted of 24 femoral fractures (16 A2, 1 A3, 4 B1, 3 B2)
and 24 tibial fractures (9 A2, 14 A3, 1 B3).
Surgical time was calculated from incision until skin
suture and confront was done using a parametric test for
paired data (Student’s t test).
The study was approved by the local ethics committee
and conducted according to the Declaration of Helsinki; the
patients gave their informed consent prior to inclusion.
Results
Average surgical time in the Fixion nail group was 55 min
(range, 35–90; SD, 12.5) versus 74 min in the control group
(range, 50–110; SD, 14.09). This difference is statistically
124 J Orthopaed Traumatol (2008) 9:123–128
123
significant (P \ 0.0001). Postoperative checks evidenced
good alignment in all cases with a good rotation and banding
control: no angulation of[5 or clinically evident rotatory
deformity was observed. Shortening was evaluated clini-
cally by referring to the other limb: a shortening of[2 cm
was observed in two cases of femoral fracture (1B1, 1B2)
and in one case of tibial fracture (1B3); nevertheless,
information about the pre-injury state was not available. The
healing process appeared to be slower: radiological healing,
that is the presence of bone bridges in at least three of the
four corticals arose in three-quarters of the cases at the six-
month control and in only one-quarter of them previously.
We report the following complications here: a case of
intraoperative fracture widening with no effect on the
treatment; a lesion of the tip of the nail with pneumatic
system rupture that necessitated nail substitution; two cases
of retarded consolidation at six months, where both tibial
fractures were treated successfully with intralesion platelet
gel; a case of nail incarceration on 17 removals, resolved
by shearing. No cases of clinically evident compartment
syndrome or pulmonary embolism were observed.
Discussion
The intramedullary nailing story started in the 1950s with
the Kuntscher nail. Using a large-dimension nail after canal
reaming was mandatory in order to guarantee rotatory
stability [18]. However, this option was (and still is)
associated with complications such as intramedullary
Fig. 1 Male, 32 years old: preoperative X-rays showing a type A3
fracture
Fig. 2 One-month postoperative X-rays
Fig. 3 Three-month postoperative X-rays
J Orthopaed Traumatol (2008) 9:123–128 125
123
material embolism (particularly dangerous in polytrauma-
tism with respiratory distress) and an increased risk of
infection, particularly in open fractures. Furthermore,
associated intramedullary circulation damage causes a
decrease in endosteal callus [19–21].
The expandable Fixion nail may be inserted without
reaming, ensuring rotatory stability, just as for bigger nails.
However, it is necessary to evaluate if the high contact
pressure inside the intramedullary canal slows down the
healing process. This would explain the retarded radio-
graphic healing observed in our series. Difficulty with
performing distal locking is a problem in intramedullary
locked stabilization. This is particularly evident in the
femur more than in the tibia: because of the ‘‘procurvatum’’
present in the femoral shape, the nail inserted into the canal
is subject to slight deformation, so that the external guide
becomes less efficient, forcing the surgeon to operate using
an X-ray image intensifier; this is potentially dangerous for
him, the patient and for other people involved [22]. The use
of the expandable intramedullary nail can circumvent this
problem. An average decrease of 20 min in intraoperative
time was observed because of it is easier to introduce and
there is no locking time. It is important to avoid damaging
the expansion system, which is particularly frail at the tip,
in order to avoid the need to change the nail. Because of its
characteristics, it is appropriate for treating femoral frac-
tures classified as A2, A3, B1 and B2 and localized 7 cm
distally from the lesser trochanter and 15 cm proximally to
the knee joint rim. We consider type A1 and B3 fractures to
be contraindications: type A1 because of the oblique bor-
ders and and type B3 because it is a multifragmentated
fracture and the risk of limb shortening is too high. A
Fig. 4 Six-month postoperative X-rays showing the radiological
healing process
Fig. 5 Male, 41 years old: preoperative X-rays showing a type A3 femoral fracture and a type A3 tibial fracture
126 J Orthopaed Traumatol (2008) 9:123–128
123
representative case of femoral fracture is shown (Figs. 1, 2,
3). In the tibia we used the expandable nail for types A2,
A3, B2 and B3, localized 7 cm distally from the tibial
tuberosity and 7 cm proximally to the distal canal end; we
did not treat A1 and B1 fractures because they were obli-
que. A second case of both femoral and tibia fracture is
also shown (Figs. 4, 5, 6, 7). In our series, the results were
considered satisfactory; evident problems concerning limb
shortening that forced Wade et al. [23] to stop their pro-
spective study were not observed.
Further studies are needed to evaluate the clinical and
radiological healing times, which were increased in our
series, and the importance of limb shortening for type AO
fractures, considering that in the abovementioned study the
authors used the expansion system for type A1 femoral
fractures as well as for type A1 and B1 tibial fractures. All
possible advantages should be taken into account when
considering the elevated cost of the Fixion nail. Its use may
be considered as a second choice for transverse and short
oblique fractures in femur and tibia.
Fig. 6 One-month postoperative X-rays
Fig. 7 Three-month postoperative X-rays
J Orthopaed Traumatol (2008) 9:123–128 127
123
Conflict of interest statement The authors declare that they have
no conflict of interest related to the publication of this manuscript.
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Clinical and radiological midterm results from using the Fixion expandable intramedullary nail in transverse and short oblique fractures of femur and tibia

A prospective, randomized study of intramedullary nails inserted with and without reaming for the treatment of open and closed fractures of the tibial shaft.

An expandable intramedullary nail for ﬁxation of osteoporotic bone. Internal ﬁxation in osteoporotic bone. Thieme Verlagsgruppe,

An expandable nailing system or the management of pathologic humerus fractures. Arch Orthop Trauma Surg

Biomechanics of intramedullary fracture ﬁxation.

Comparative study on the effect of reamed and nonreamed intramedullary nails on treating open tibial fractures. Zhongguo Xiu Fu Chong Jian Wai Ke Za

Complications of reamed intramedullary nailing of the tibia.

De Amicis A

Early treatment results with expandable intramedullary nails in lower extremity shaft fractures.

Expandable nail system for osteoporotic humeral shaft fractures: preliminary results.

Fixion nails for humeral fractures.

Interlocking intramedullary nailing with and without reaming for the treatment of closed fractures of the tibial shaft. A prospective, randomized study.

Intramedullary nailing of the femur with an inﬂatable self-locking nail: comparison with locked nailing.

Intramedullary surgical technique and its place in orthopaedic surgery. My present concept.

Literature review of current techniques for the insertion of distal screws into intramedullary locking nails.

Preliminary clinical and radiographic results with the Fixion intramedullary nail: an inﬂatable self-locking system for long bone fractures.

Retrospective analysis of healing problems after reamed and unreamed nailing of femoral shaft fractures.

Sermon A

Stability of reamed and unreamed intramedullary tibial nails: a biomechanical study.

Systemic complications in intramedullary nailing.

The comprehensive classiﬁcation of fractures of long bones.

The Fixion nail in the lower limb. Preliminary results.

The use of an innovative inﬂatable self-locking intramedullary nail in treating and stabilizing long bone fractures. Technique—preliminary results. Osteo Trauma Care 11:S108–S112

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Clinical and radiological midterm results from using the Fixion expandable intramedullary nail in transverse and short oblique fractures of femur and tibia

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