Abstract
Background: Operative treatment of tibial fractures in children
requires implants that do not violate open physes while maintaining tibial
length and alignment. Both elastic stable intramedullary nails and external
fixation can be utilized. We retrospectively reviewed our experience with
these two techniques to determine if one is superior to the other.
Methods: We retrospectively reviewed the operative records and
trauma registries of three institutions within our hospital system and
identified thirty-five consecutive patients with open physes who had undergone
operative treatment of a tibial fracture between April 1997 and June 2004.
Four patients were excluded because they had been managed with locked
intramedullary nails or with pins and plaster. Of the thirty-one remaining
patients, sixteen had been managed with elastic stable intramedullary nails
and fifteen had been managed with unilateral external fixation. The clinical
and radiographic outcomes were compared. The functional outcomes were compared
with use of the Pediatric Outcomes Data Collection Instrument. Complications
related to treatment, such as malunion, delayed union, nonunion, infection,
and the need for subsequent surgical treatment also were compared.
Results: Thirty-one patients with thirty-one operatively treated
tibial fractures were available for evaluation. Fifteen patients had been
managed with external fixation. Seven of these patients had a closed fracture,
and eight had an open fracture. There were seven healing complications in this
group, including two delayed unions, three nonunions, and two malunions.
Sixteen patients had been managed with elastic stable intramedullary nailing.
Eleven patients had a closed fracture, and five had an open fracture. The mean
time to union for the intramedullary nailing group (seven weeks) was
significantly shorter than that for the external fixation group (eighteen
weeks) (p < 0.01). The functional outcomes for the intramedullary nailing
group were significantly better than those for the external fixation group in
the categories of pain, happiness, sports, and global function (the mean of
the mean scores of the first four categories) (p < 0.01 for these
comparisons).
Conclusions: When surgical stabilization of tibial fractures in
children is indicated, we believe that the preferred method of fixation is
with elastic stable intramedullary nailing.
Level of Evidence: Therapeutic Level III. See
Instructions to Authors for a complete description of levels of evidence.
Diaphyseal fractures of the tibia are common injuries in
children1; however,
very few require surgical
stabilization2,3.
Surgical stabilization may be indicated for children in whom acceptable
positioning is not maintained after closed reduction; those who are ten years
of age and older4;
those who have selected open fractures; those who have an associated
compartment syndrome; those who have spasticity due to head injury or cerebral
palsy; those who have multiple long-bone fractures or multiple-system
injuries; and those who have concomitant severe soft-tissue
injuries4-8.
Tibial fractures requiring surgical stabilization are treated differently
in children than in adults. Locked intramedullary rods are not used in
children because of the risk of physeal injury. Treatment options include
external
fixation5,9,10,
elastic stable intramedullary
nailing11-14,
and transfixation pins and
casts12,15.
Intramedullary fixation with elastic nails that are placed percutaneously
through the proximal tibial metaphysis without violating the physis has become
a popular technique for the treatment of pediatric femoral
fractures14,16,17.
Two flexible intramedullary nails, introduced in an antegrade or retrograde
fashion, cross the fracture site and act as internal splints to maintain
length and alignment while allowing sufficient fracture motion to generate
callus formation. This technique is commonly referred to as elastic stable
intramedullary nailing or flexible intramedullary
nailing14. It has
been used successfully for the treatment of pediatric fractures of the tibia,
femur, humerus, and
forearm11,13,14,17-19.
External fixation traditionally has been the method of choice for the
stabilization of open tibial fractures in children when cast immobilization is
not
sufficient5,9,10,20.
It provides excellent stability and allows for multiple débridements of
soft-tissue injuries.
The purpose of the present study was to analyze the results of surgical
stabilization of pediatric tibial fractures with use of elastic stable
intramedullary nailing and external fixation.
The two appropriate institutional review boards that govern the
hospitals within our institution approved this retrospective analysis of
consecutive patients with open physes who had undergone operative treatment of
diaphyseal tibial fractures within our hospital system from April 1997 to June
2004. The criteria for inclusion in the study were a tibial shaft fracture
that had been treated with either elastic stable intramedullary nailing or
external fixation, a minimum duration of postoperative follow-up of two years,
open physes at the time of the injury, and fracture union at the time of the
final review. For the purposes of the present study, we sought to determine
which method of stabilization was more effective for the treatment of
fractures that required surgery. Elastic stable intramedullary nailing and
external fixation were the methods of operative treatment that were employed
at our institutions during the study period. The indications for operative
treatment were consistent with those discussed in the introduction.
Patients were identified through a search of the trauma databases and
operative logs of our two level-I metropolitan trauma centers and a tertiary
referral hospital. All patients had been managed by one of the authors
(K.A.E., D.S., D.F., or K.J.K.). After the patients had been identified, their
radiographs and charts were reviewed. Patients with epiphyseal fractures and
metaphyseal fractures were excluded from the study group. Thirty-five patients
were identified, and four patients were excluded because they had been managed
with locked intramedullary nails or with pins and plaster.
Demographic data included the age and gender of the patient; the side and
mechanism of the injury; the description of the fracture pattern according to
the AO/Orthopaedic Trauma Association system for the classification of
diaphyseal tibial
fractures21; the
fracture classification according to the system of Gustilo and Anderson (for
open fractures)22;
and the presence of associated injuries (including long-bone injuries, closed
head injuries, and chest and abdominal injuries). We identified the method of
surgical stabilization and the timing of the initial surgical intervention,
technical complications, postoperative weight-bearing status, additional
surgical procedures, the time of hardware removal, and fracture-related
complications. Fractures that had taken six months or longer to unite but that
had demonstrated progression toward union on serial radiographs were defined
as delayed
unions23-26.
Fractures that were associated with persistent pain and motion combined with
radiolucency at the fracture site without progressive callus formation on
three sequential radiographs after six months of fixation were defined as
nonunions23-25.
Fractures were considered to be united radiographically when there was
evidence of bridging callus on three of four cortices on anteroposterior and
lateral
radiographs27.
Deformity was assessed on radiographs that had been made at the time of
injury, following surgical stabilization, and at the time of the last
follow-up. Malunion was considered to have occurred when there was =10°
of valgus or varus angulation at the fracture site or when there was
=20° of anterior or posterior
angulation28-30.
All measurements were made by a single independent evaluator (E.N.K.).
The method of surgical stabilization was determined by the senior pediatric
orthopaedic surgeon or senior orthopaedic trauma surgeon (K.A.E., D.S., D.F.,
or K.J.K.). External fixation was performed with unilateral pin-to-bar
fixators (EBI, Parsippany, New Jersey, or Synthes, Paoli, Pennsylvania) with
use of standard AO
principles9,10,20.
Four bicortical self-drilling fixator pins were placed in the tibia, two
proximal and two distal to the fracture site, under fluoroscopic guidance. The
pins were placed to ensure a maximum pin interval in the proximal and distal
fracture fragments. Pins were placed a minimum of 1 cm from the proximal
and/or distal physis. Carbon-fiber connecting rods were then loosely connected
to the pins. The fracture was reduced with the assistance of fluoroscopy.
After adequate reduction was obtained, the connectors between the Schantz pins
and the carbon-fiber rods were securely tightened and the reduction was
radiographically confirmed with full-length anteroposterior and lateral
radiographs. At least two stacked carbon-fiber rods were used in each
construct, and the distance from the bone to the connecting rods was kept to
the absolute minimum necessary in order to facilitate dressing changes and to
allow for soft-tissue swelling. External fixators typically were dynamized at
six weeks to encourage the completion of fracture union. The external fixators
were removed when there was radiographic evidence of bridging callus on three
of four cortices and the patient had no pain at the fracture site when bearing
weight on the dynamized external fixator. Pins were removed in the operating
room, and the pin sites were curetted. Most patients were managed with a
below-the-knee plaster posterior splint and remained non-weight-bearing until
the first postoperative visit at one week. The splint was then removed, and
the patient was allowed to bear weight as tolerated.
We inserted elastic stable intramedullary nails (DePuy, Warsaw, Indiana, or
Synthes) with the patient supine on a radiolucent operating table. The lower
extremity was prepared and draped. A tourniquet was not used. The flexible
nails were prebent so that the apex of their curvature would be at the
fracture site as confirmed fluoroscopically. The location of the proximal
tibial physis was marked on the skin with use of the image intensifier.
Through small incisions, the soft tissues deep to the dermis were bluntly
dissected and the periosteum was exposed. With use of a soft-tissue protector,
drill-holes were made in the anteromedial and anterolateral cortices of the
proximal part of the tibia, approximately 1 cm distal to the proximal tibial
physis and 2 cm posterior to the tibial tubercle apophysis. Under fluoroscopic
guidance, the medial and lateral prebent flexible nails were successively
advanced from the tibial metaphysis into the diaphysis, across the fracture
site, and into the distal fragment, to a point approximately 1 cm proximal to
the distal tibial physis. An F-shaped reduction tool and stacked towels were
employed to facilitate fracture reduction. After final confirmation of
fracture reduction and proper implant location, the proximal ends of the nails
were cut such that they were left 5 mm proud of the cortex. Following wound
closure, the extremity was placed in an AO splint, which generally was removed
and replaced with a fracture boot on the fifth, sixth, or seventh
postoperative day. The patient was encouraged to remove the fracture boot
every hour for ankle range-of-motion exercises. No patient was managed with a
cast after elastic stable intramedullary nailing. Weight-bearing status was
determined on the basis of fracture stability: patients who had =50%
cortical contact in the transverse plane were allowed to bear weight with
crutches as tolerated.
All patients were contacted and were asked to return for a follow-up
evaluation consisting of both a clinical and a radiographic examination. The
clinical examination included observation of the patient's gait; inspection of
the wound; palpation of the fracture site; determination of the active and
passive ranges of motion of the hips, knees, and ankles; and a neurovascular
examination of the lower extremities. The radiographic evaluation consisted of
anteroposterior and lateral radiographs of the leg, including the knee and
ankle joints, made with the patient supine. Standing radiographs of the lower
extremities were made for patients who demonstrated clinical deformity or
unequal leg lengths. The patient was considered to have a successful fracture
union when there was no pain to palpation over the fracture site, minimal to
no pain with full weight-bearing, no motion at the fracture site, and evidence
of bridging callus on three of four cortices as seen on orthogonal
radiographs27.
After informed consent had been obtained, patients and their parents were
asked to complete the Pediatric Outcomes Data Collection Instrument (PODCI)
Pediatrics—Parent/Child or
Pediatrics—Parent/Adolescent Follow-up Questionnaire developed
by the American Academy of Orthopaedic Surgeons, the Pediatric Orthopaedic
Society of North America (POSNA), the American Academy of Pediatrics, and
Shriners Hospitals to evaluate functional
outcomes31,32.
This 115-item questionnaire assesses six functional dimensions: (1) upper
extremity functioning, (2) transfers and basic mobility, (3) sports and
physical function, (4) comfort/pain, (5) global function (calculated as the
mean of the mean scores for the previous four dimensions); and (6) happiness
with physical condition. The scores for all dimensions are scaled from 0 to
100 points, with scores of 100 points representing the highest level of
function and scores of <80 points indicating severe
disability31. The
validity, reliability, and sensitivity to change of this instrument has been
investigated
previously32. The
calculated point values in the present study are based on the algorithms
developed by the Pediatric Orthopaedic Society of North America
questionnaire-development group for version 2.0 (dated September 1997).
Statistical Analysis
All data were analyzed with use of Prism Statistical Software (Graphpad
Software, San Diego, California). The chi-square test or the Student t test
was used when appropriate. The level of significance was set at p <
0.05.
Thirty-one children with thirty-one tibial fractures were studied.
Fifteen patients had been managed with external fixation
(Figs. 1-A and 1-B). This group
consisted of ten boys and five girls with a mean age of 10.3 years (range,
four to fifteen years). The mean duration of follow-up for this group was 3.5
years (range, two to 6.7 years). The other sixteen patients had been managed
with elastic stable intramedullary nailing
(Figs. 2-A through 2-F). This
group included eleven boys and five girls with a mean age of eleven years
(range, seven to fourteen years). The mean duration of follow-up for this
group was 2.9 years (range, two to 5.8 years). The differences between the two
treatment groups with regard to the duration of follow-up, age, and
male:female ratio were not significantly different, with the numbers available
(see Appendix). Two patients in the external fixation group and two patients
in the elastic stable intramedullary nailing group were unable to return for a
final follow-up evaluation. The latest clinical follow-up for these patients,
as recorded in the medical records, had been at 4.4, 2.3, 2.8, and 4.3 years,
and these dates were used as the dates of the final follow-up. These four
patients and their parents were contacted by telephone by a trained
interviewer, and Pediatric Outcomes Data Collection Instrument functional
outcomes questionnaires were completed.
All patients underwent secondary procedures for hardware removal. The mean
time-interval between the initial procedure and hardware removal was sixteen
weeks (range, seven to twenty-nine weeks) for the external fixation group and
thirty-six weeks (range, sixteen to seventy-eight weeks) for the elastic
stable intramedullary nailing group (p < 0.01).
All fractures had united at the time of the latest followup. The mean time
to union was eighteen weeks (range, eight to thirty-seven weeks) for the
external fixation group and seven weeks (range, five to twelve weeks) for the
elastic stable intramedullary nailing group. This difference was significant
(p < 0.01). There were seven fracture-healing complications in six patients
in the external fixation group, including two delayed unions, three nonunions,
and two malaligned fractures (one of which was also a nonunion). The two
delayed unions were treated with bone stimulators and fixator dynamization and
subsequently united at thirty-five and thirty-seven weeks after the
injury.
Four of the six patients with healing complications had sustained an open
fracture, although none required additional soft-tissue procedures to provide
coverage. The three nonunions eventually healed, but only after additional
surgical intervention (conversion to a ring fixator with compression across
the nonunion site). One malalignment occurred in a patient in whom the
external fixator had become loose at the time of dynamization at six weeks.
The external fixator was converted to a ring fixator, and the fracture healed
without additional complications.
One patient in the elastic stable intramedullary nailing group had a
bone-healing complication. In this patient, pain developed in the posterior
part of the calf six months after the injury. Radiographs revealed exuberant
posterior bone formation at the fracture site, with resultant irritation of
the soleus muscle. The bone was excised at the time of hardware removal at
seventeen weeks. The patient had no pain one year later. Most notably, no
patient in the elastic stable intramedullary nailing group was noted to have
clinically important shortening or rotational abnormalities at the time of the
latest follow-up. Patients who had been managed with elastic stable
intramedullary nailing had significantly fewer bone-healing complications than
those who had been managed with external fixation (p < 0.01).
Complications that were unrelated to bone-healing were observed in both
groups. Two patients in the external fixation group had development of
pin-track infections that were successfully treated with oral antibiotics and
local pin-site care without premature removal of the fixator. One patient in
the elastic stable intramedullary nailing group had an unrecognized
ipsilateral anterior compartment syndrome. This patient had sustained a crush
injury at the time of the fracture and was noted to have decreased function of
the extensor digitorum communis and extensor hallucis longus in the emergency
room. Measurements of compartment pressure in the emergency room and in the
operating room before and after surgical fixation revealed values of <20 mm
Hg in all four compartments. Six months after fixation, the patient had a
dorsiflexion contracture of 20° and complained of pain at the proximal
ends of the nails. The hardware was removed in the operating room, and the
anterior compartment was opened and explored. The extensor hallucis longus was
noted to be noncontractile and quite scarred. The anterior tibialis was
contracted. Fractional lengthening of the anterior tibialis tendon and
transfer of the extensor hallucis tendon to the extensor digitorum communis
was performed, as was a complete anterior compartment fasciotomy. One year
later, the foot was in neutral, the ankle had 20° of active dorsiflexion
and 30° of active plantar flexion, and the patient was pain-free. This
complication was attributed to the degree of soft-tissue injury that had been
sustained at the time of the fracture and not to the insertion of the elastic
titanium nails. Additionally, in the elastic stable intramedullary nailing
group, most patients complained of irritation over the proximal ends of the
flexible nails. However, no patient required premature removal of the nails or
treatment with antibiotics.
The postoperative weight-bearing status and postoperative immobilization
times for the external fixation group were similar to those for the elastic
stable intramedullary nailing group. Of the fifteen patients in the external
fixation group, five were allowed partial weight-bearing after the initial
injury and ten were non-weight-bearing. Four of the patients in this group
were managed with posterior splint immobilization. Of the sixteen patients in
the elastic stable intramedullary nailing group, twelve were
non-weight-bearing and were managed with posterior splint immobilization after
the initial injury, three were allowed partial weight-bearing, and one was
allowed to bear weight as tolerated.
Pediatric Outcomes Data Collection Instrument functional outcome data were
obtained for both groups (Fig.
3). Patients who had been managed with elastic stable
intramedullary nailing had better scores in all of the subcategories,
including pain and comfort (mean, 92.1 points [range, 35 to 100 points] for
the elastic stable intramedullary nailing group compared with 70.5 points
[range, 32.8 to 100 points] for the external fixation group; p < 0.01),
happiness with physical condition (mean, 93.7 points [range, 57.5 to 100
points] for the elastic stable intramedullary nailing group compared with 71.0
points [range, 24.5 to 100 points] for the external fixation group; p <
0.01), sports and physical function (mean, 92.1 points [range, 52.6 to 100
points] for the elastic stable intramedullary nailing group compared with 71.0
points [range, 60.3 to 100 points] for the external fixation group; p <
0.01), and global function (mean, 97.7 points [range, 75 to 100 points] for
the elastic stable intramedullary nailing group compared with 85.7 points
[range, 24.5 to 100 points] for the external fixation group; p < 0.01).
Only one patient in the elastic stable intramedullary nailing group had an
overall score of <80 points (70 points), whereas four patients in the
external fixation group had an overall score of <80 points (74, 61, 61, and
76 points) (p < 0.05); this is an important difference as scores of <80
points are indicative of severe
disability31.
The majority of diaphyseal tibial fractures, even open fractures, in
children can be treated with closed reduction and cast
immobilization1,15,24,25,33.
In certain cases, however, surgical stabilization is
required4-8.
Various methods of surgical stabilization have been utilized, including
crossed Kirschner wires, Steinmann pins and plaster
immobilization15,19,34,
external
fixation5,9,34,
and flexible or nonflexible intramedullary
nails11,14,19.
Currently, there is no consensus on the optimal implant choice. Enthusiasm for
external fixation has been tempered by the presence of pin-track infections,
an increased prevalence of nonunion, and an increased risk of
refracture5,9,20,35.
Newer titanium elastic nails have been specifically designed for the treatment
of diaphyseal fractures in children and currently are used for the treatment
of pediatric femoral
fractures11,16-18,36
and, increasingly, for surgical stabilization of pediatric tibial
fractures14,19.
With the numbers available, the external fixation group and the elastic
stable intramedullary nailing group did not differ significantly with respect
to demographic data. However, there were significant differences between the
groups with respect to the time to fracture union, the rate of bone-healing
complications, the time to removal of hardware, and functional outcomes.
The mean time to union was eighteen weeks in the external fixation group,
compared with seven weeks in the elastic stable intramedullary nailing group.
These findings are similar to those of Cullen et
al.15, who reported
a mean time to union of fifteen weeks in their series of eighty-three open
tibial fractures in children (mean age, nine years) who had been managed with
external fixation. Our results are also similar to those of
Qidwai19, who
reported a mean time to union of 9.4 weeks in a study of eighty-four tibial
fractures (including thirty open fractures) in children (mean age, 10.2 years)
who had been managed with Kirschner wires that had been placed in the same
fashion as described for the flexible titanium nails in the present study.
Nonunion of pediatric long-bone fractures generally is associated with open
fractures, osseous defects, infection, and/or open reduction and internal
fixation33,34,37.
In the present series, two patients had delayed union, two patients had
development of a malunion, and three patients had development of a nonunion.
All of these patients had been managed with external fixation, and all had
union with no additional complications after conversion to circular frames and
an additional mean healing time of twenty-eight weeks. There were no delayed
unions or nonunions in the elastic stable intramedullary nailing group.
To our knowledge, the only other study comparing the results of elastic
stable intramedullary nailing with those of external fixation was a
prospective, randomized study of twenty pediatric femoral fractures as
reported by Bar-On et
al.35. In that
series, the patients in the elastic stable intramedullary nailing group (mean
age, eight years) had more exuberant callus formation than those in the
external fixation group (mean age, nine years). In addition, the time to full
weight-bearing in the elastic stable intramedullary nailing group (seven
weeks) was three weeks shorter than that in the external fixation group (ten
weeks).
In the present study, patients who had been managed with elastic stable
intramedullary nailing had significantly better functional results than those
who had been managed with external fixation. There is no consensus in the
literature about when a child's functional status is expected to return to
baseline after a tibial fracture that is severe enough to necessitate surgical
stabilization. Despite the fact that the overall duration of follow-up in the
present study was short, the patients in the elastic stable intramedullary
nailing group and many of the patients in the external fixation group had high
functional scores at the time of the latest follow-up.
Other authors have reported increased levels of patient satisfaction in
association with elastic stable intramedullary nailing. Till et
al.11 reported a
similarly high level of patient satisfaction in a series of seventy patients
with long-bone fractures that had been treated with elastic stable
intramedullary nailing, fourteen of which involved the tibia. Sixty-four
patients (91%) described their functional ability as perfect, and sixty-five
patients (93%) reported that their contentment with the procedure was great.
Bar-On et al.35
reported that all of the parents of the ten children who had been managed with
elastic stable intramedullary nailing would have their children undergo the
same treatment again, whereas the parents of two of the eight patients who had
been managed with external fixation would opt for nonoperative treatment for
their children in the future. No previous study involved the use of a
patient-determined, objective, validated functional outcomes instrument to
evaluate treatment outcome.
The limitations of the present study included its retrospective nature and
the small number of tibial fractures in skeletally immature patients that
required surgical stabilization. Additionally, we have no means to track how
many tibial fractures were treated with closed means during this time-period,
which makes a comparison between operative and nonoperative treatment
impossible for this patient cohort. The rarity of this type of fracture
limited the number of fractures that were available for analysis in the
present study and will make any future prospective studies comparing external
fixation and elastic stable intramedullary nailing equally difficult. The
difference between the groups with regard to the number of open fractures,
although not significant, may have partly explained the differences between
the two groups with respect to healing time and outcomes. A future
prospective, randomized, multicenter study would help to resolve these issues
by providing a greater sample size and by removing any treatment selection
bias.
On the basis of the results of the present study, we recommend that elastic
stable intramedullary nailing be used for the treatment of tibial fractures in
skeletally immature patients in need of surgical stabilization. We believe
that it is appropriate for the treatment of open tibial fractures without
segmental bone loss and limited comminution. However, a larger prospective
study is needed to confirm these findings.
A table presenting clinical data on all patients is available with the
electronic versions of this article, on our web site at
(go to
the article citation and click on "Supplementary Material") and on
our quarterly CD-ROM (call our subscription department, at 781-449-9780, to
order the CD-ROM).
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