Question: In children with femoral fractures, how does early
application of hip spica compare with external fixation with regard to
malunion rates, physical function, behavioral disturbances, and patient
satisfaction?
Design: Randomized (allocation concealed), blinded (outcome
assessor), controlled trial with 2-year follow-up.
Setting: 4 pediatric hospitals in Toronto, Ontario, Canada;
Melbourne, Victoria, Australia; Los Angeles, California, United States; and
Auckland, New Zealand.
Patients: 108 children who were 4 to 10 years of age (mean age, 6 y;
70% boys) and had femoral fractures. Exclusion criteria were hip fracture,
distal femoral physeal fracture, head injury (Glasgow Coma Scale score
<11), pathological fracture, or open fracture. 94% of children were
followed.
Intervention: Children were allocated to early hip spica (n = 60) or
external fixation (n = 48). Children in the hip-spica group received general
anesthesia. The fractured limb, not including the foot, was placed in a cast
with the hip and knee flexed about 70°. Treatment guidelines for early
application of hip spica were followed. Adequate closed reduction was defined
as 1 to 2 cm of shortening, no posterior angulation, <20° of anterior
angulation, no varus angulation, and <15° of valgus angulation.
Children in the external-fixator group received general anesthesia for a
closed reduction of the fracture and application of a dynamized Orthofix
external fixator (Orthofix, McKinney, Texas). Satisfactory reduction was
defined as =1 cm of overlap, <15° of varus or valgus angulation, and
<20° of anterior or posterior angulation. Children in both groups were
allowed to walk with crutches, if able, and were discharged from the hospital
and followed weekly as outpatients.
Main outcome measure: Fracture malunion (limb-length discrepancy of
>2 cm, >15° of anterior or posterior angulation, or >10° of
varus or valgus angulation). Secondary outcomes included physical function and
behavioral disturbances (Children Health Information Rand scale) and patient
satisfaction (rating scales completed by parents and children).
Main results: Analysis was by intention to treat. The malunion rate
was higher in the hip-spica group than in the external-fixator group
(Table). Groups did not differ
with regard to total or subscale scores on the Children Health Information
Rand scale or with regard to patient satisfaction scores.
Conclusions: In children with femoral fractures, hip-spica treatment
led to a greater rate of fracture malunion than did external fixation. The
scores on the Children Health Information Rand scale and with regard to
patient satisfaction were similar in both groups.
For decades, orthopaedists used spica casting, with and without traction,
to treat almost all femoral fractures in children and adolescents. In the past
20 years, there has been a strong trend toward the use of internal or external
fixation of pediatric femoral fractures for 2 reasons: the incidence of
malunion appears to be unacceptably high with spica cast management, and
socioeconomic changes have driven surgeons to mobilize children quickly after
a femoral fracture. The randomized trial by Wright et al. of pediatric femoral
fractures treated by casting or external fixation provides essential evidence
in the ongoing debate regarding the treatment of pediatric femoral
fractures.
The strengths of this study are its prospective, multicenter randomized
design, its 2-year follow-up, and the inclusion of both outcome and patient
satisfaction data. This study is perhaps the most rigorously designed
pediatric femoral fracture trial available in the literature. Clinical
assessments at 2 years, performed with the use of blinded evaluations, provide
a reliable estimate of how these patients fared after undergoing 1 of 2
treatment methods. Although there was a significant difference in the number
of malunions, parents and children were equally satisfied with the results at
2 years. This finding highlights the adaptability of young children to a
femoral malunion and emphasizes the importance of using nonradiographic
outcome measures in all pediatric femoral fracture trials.
The principal shortcoming in this trial relates to its generalizability.
When this trial was designed in the early 1990s and started in 1994, external
fixation was the standard treatment method for pediatric femoral fracture at
many centers. In the past 10 years, external fixation has largely been
replaced by flexible intramedullary nailing. In this trial, 15% of children
had either a refracture or an operative adjustment of the fixator. These are
the factors that have led to less enthusiasm for external fixation as a
treatment. Therefore, perhaps the most important generalizable information in
this study relates to the spica-casting group, not the external-fixator group.
This study presents the strongest evidence to date for questioning the
efficacy of spica cast treatment of femoral fractures in children who are
older than 4 years of age.