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BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Background: The Ponseti method is an established approach to treating idiopathic clubfoot in infants. The method
involves a period of cast immobilization and postcorrective bracing that potentially interferes with normal movements of
the lower extremities. In the present study, we investigated the age at which infants who had idiopathic clubfoot treated
using the Ponseti method achieved independent walking.
Methods: We prospectively evaluated patients of a single surgeon. Included in the study were all patients with idiopathic
clubfoot who were full term at birth, were no more than twelve weeks of age at the start of treatment, had received no prior
outside treatment, and were followed for a minimum of twenty-four months.
Results: Ninety-four patients were included. The mean age at which patients began walking independently was 14.5
2.6 months (range, ten to twenty-two months). By eighteen months, 90% of the patients were walking without assistance.
Patients with moderate or severe clubfoot deformity began walking earlier than did patients with very severe deformity (a
mean of 14.2 months compared with 15.8 months; p = 0.03). Patients who experienced a relapse before learning to walk
began walking later than those who did not relapse (a mean of 15.9 months compared with 14.2 months; p = 0.04). Other
patient and treatment-related variables had no significant influence on the onset of walking.
Conclusions: On the basis of our findings, parents of infants with idiopathic clubfoot treated using the Ponseti method
may expect their child to achieve independent walking approximately two months later than infants without clubfoot
deformity. A greater delay may be expected for those patients who have a very severe deformity or those who experience a
deformity relapse.
Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed
by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication.
Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
he Ponseti method is a well-established and widely accepted approach to treating idiopathic clubfoot in
infants1-5. The technique involves a series of specific
manipulations and cast applications to correct the forefoot,
midfoot, and subtalar components of the deformity. A percutaneous Achilles (heel-cord) tenotomy is usually required to
address any remaining equinus and provide final correction of
the foot. After the foot is corrected, a foot abduction orthosis is
used to prevent a relapse of the deformity. This device is worn
full time for three months and then at night and at naptime
until the child is at least four years old.
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any
aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work,
with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has
had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this
work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
http://dx.doi.org/10.2106/JBJS.M.01525
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P Value
94 (100%)
14.5 2.6
N/A
Sex
Male
Female
68 (72%)
26 (28%)
14.3 2.7
15.1 2.5
0.17
Bilaterality
Yes
No
50 (53%)
44 (47%)
14.2 2.6
14.9 2.6
0.23
76 (81%)
18 (19%)
14.2 2.5
15.8 2.8
22 (23%)
72 (77%)
14.4 2.8
14.5 2.6
0.03
0.89
*Values are presented as the mean and standard deviation. N/A = not applicable.
the Ponseti technique. The authors noted that they did not have a
sufficient number of patients to evaluate the effect of other variables, such as unilateral or bilateral involvement.
The purpose of the present study was to determine, with
use of a prospective, single-surgeon database, the age at which
infants with idiopathic clubfoot treated with the Ponseti method
begin to walk. We also evaluated the influence of other factors,
such as sex, bilaterality, severity of deformity, and early relapse, on
the achievement of independent walking.
Materials and Methods
his study was approved by the institutional review board of the University
of California, Los Angeles. We invited families of infants who had been
diagnosed with idiopathic clubfoot and were initially seen at our clinic between
July 2006 and August 2011 to participate in this prospective study. Exclusion
criteria included a gestational age of less than thirty-seven weeks, an age of more
than twelve weeks at the start of treatment, prior outside treatment, mild or
positional deformity, or orthopaedic problems other than clubfoot that might
affect motor development. We also excluded patients who were lost to followup prior to reaching twenty-four months of follow-up at our institution.
The severity of the foot deformity was graded at initial presentation by
8
the senior author (L.E.Z.) using the Dimeglio scale , a classification scheme
9
with very good interobserver relability . Feet were classified into one of four
categories: Grade I (0 to 4 points, mild), Grade II (5 to 9 points, moderate),
Grade III (10 to 14 points, severe), and Grade IV (15 to 20 points, very severe).
For infants with bilateral clubfoot, the greater of the two Dimeglio scores was
used for the analysis. Infants with a mild deformity (Grade I) were excluded
because the treatment of these feet was usually less extensive and often differed
from the standard Ponseti method.
The feet were manipulated at weekly intervals as prescribed by the Ponseti
2
method . The cavus, adductus, and varus components of the deformity were
corrected by positioning the foot in supination and then abducting the foot while
counter pressure was applied with the thumb over the head of the talus. We
applied casts using semi-rigid fiberglass material (3M Scotchcast Soft Cast Casting
Tape; 3M, St. Paul, Minnesota). When the foot achieved 70 of abduction relative
to the thigh, a heel-cord tenotomy was deemed indicated if there was less than 15
of dorsiflexion. Tenotomies were performed in the operating room with the
10
patient under sedation, after which a cast was worn for three weeks .
After the last cast was removed, the infants were fitted with a Mitchell11
Ponseti (MP) brace (MD Orthopaedics, Wayland, Iowa) . The parents were
instructed to apply the brace for twenty-three hours a day for three months,
followed by use at night and at naptime. In general, we instructed the parents to
perform heel-cord stretching exercises on the child before applying the brace.
None of the infants had any formal physical therapy prior to walking.
In general, once use of the brace began, the patients were followed at
three-month intervals. At each visit, the parents were interviewed to determine
whether, and when, the patient had begun to walk independently. The validity
of the parental report was supported by observation of the infant by the physician during the clinic visit. The parental report was deemed valid if the
physician observed the infant taking ten or more steps without assistance. The
age at which walking began was recorded to the nearest month.
Other data collected included patient age, sex, side of involvement, family
history of clubfoot, number of casts needed to obtain initial correction, need for
heel-cord tenotomy, noncompliance with bracing, and early relapse of deformity.
For the purposes of the present study, noncompliance with bracing was defined
as failure to use the brace as prescribed. Relapse was defined as the reappearance
of any of the components of the clubfoot deformity requiring further treatment.
Data Analysis
power analysis was conducted to determine the sample size
required to detect a difference of one month or greater
between patients with idiopathic clubfoot and otherwise healthy
infants in terms of a delay in walking age. A standard deviation
(SD) of 2.2 months, reported in a recent study7 that investigated
the age at which patients with idiopathic clubfoot achieve gross
motor milestones, was used for this analysis. Given a power of
80% and with a = 0.05, we estimated that seventy-seven patients
in each group would be sufficient to detect a difference of one
month or greater. As previous studies have examined the age at
walking for healthy patients with the use of much larger sample
sizes (816 to 3554 patients)12-14, a control group of children without
clubfoot was not included.
Independent sample t tests were performed to quantify
the certainty (p value) associated with each of the observed
differences in the mean age at walking as influenced by patient
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Fig. 1
variables and treatment variables. The patient variables included in the analysis were sex, bilaterality, family history of
clubfoot, and the severity of deformity. The treatment variables
included were the number of casts needed prior to tenotomy,
the need for tenotomy, noncompliance with brace use, and
relapse of deformity. In addition, the Spearman correlation
coefficient was used to determine the strength of correlation, if
any, between age at walking and weeks of casting.
In addition to the analysis above, the available data from
the twelve patients who did not complete twenty-four months
of clinical follow-up and therefore were excluded from the
analysis were compared with the data from the included patients,
to determine any differences in terms of Dime glio scores, demographic characteristics, and, if available, age at walking and
outcome variables, such as relapse.
Source of Funding
No external source of funding was obtained for this study.
Results
ne hundred and seventy consecutive infants with a diagnosis of idiopathic clubfoot were initially seen at the Orthopaedic Institute for Children Clubfoot Clinic between July
2006 and August 2011. Of the 154 patients for whom consent
was obtained, ninety-four met the inclusion criteria and were
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P Value
21 (22%)
73 (78%)
14.9 2.7
14.4 2.6
0.41
14 (15%)
80 (85%)
15.9 2.6
14.2 2.6
0.04
Heel-cord tenotomy
Yes
No
89 (95%)
5 (5%)
14.5 2.6
14.0 2.6
0.69
Number of casts
4
5 or 6
7
22 (23%)
57 (61%)
15 (16%)
14.5 2.4
14.5 2.6
14.5 3.1
0.99
Fig. 2
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TABLE III Comparison with Previous Reports of Infants without Deformity on Achievement of Walking*
Present Study
13
12
WHO Multicenter
14
94
2096
816
3554
14.5 2.6
14.0
16.5
18.0
NR
12.3
13.6
14.9
12.1 1.8
12.0
13.1
14.4
NR
12.8
14.2
15.8
lost. Walking age was reported for five of the patients, a mean of
13.8 1.3 months.
Discussion
arents often perceive normalcy during their infants first
year of life based on when independent walking is achieved15. The reported mean age at which otherwise healthy
infants begin to walk has ranged from 11.7 to 12.8 months12-16.
The present study found that, among infants with idiopathic
clubfoot managed using the Ponseti method, the mean age at
which unassisted walking began was 14.5 months (range, ten
to twenty-two months).
We found that 50% of patients were walking by 14.0
months of age and 90% were walking by 18.0 months. In
contrast, in a study of 816 healthy patients, the World Health
Organization (WHO)12 reported a mean walking age of 12.1
1.8 months, with 50% of the patients walking at 12.0 months
(Table III). The difference in mean age between that of our
study and the WHO study (2.4 months) was significant (p <
0.0001). The authors of two other studies have reported the
distribution in walking age for healthy subjects13,14. Although
these studies did not present the mean and standard deviation,
on the basis of our power analysis and estimations, the patients
with clubfoot in our study walked, on average, 1.2 to two
months later than the healthy subjects of those studies (p <
0.0001).
This finding agrees with that of two other studies that
found that infants with idiopathic clubfoot, treated using the
Ponseti method, may begin to walk approximately two months
later than the walking age reported for healthy infants6,7. Garcia
et al.6 used the Alberta Infant Motor Scale (AIMS) when comparing the gross motor performance of a group of twenty-six
infants treated for idiopathic clubfoot using the Ponseti technique (twelve infants), French physical therapy method (nine
infants), or both (five infants), with that of a group of twenty-six
normally developing infants. While they found no difference in
gross motor development between the groups at three and six
months, the AIMS scores for the infants with clubfoot were
lower at nine and twelve months than the scores of the infants in
the other group. Also, the percentage of infants who were not yet
walking at twelve months was greater in the clubfoot group
(81%) than in the normal group (48%). The authors reported
that the mean age at walking was 13.9 months for the clubfoot
group. The authors acknowledged that the significance of their
findings was limited by the small sample size.
In a more recent study, Sala et al.7 evaluated the acquisition of gross motor milestones in thirty-six infants with
idiopathic clubfoot treated using the Ponseti method. They
reported that the mean age of independent walking was 13.9
months, which was approximately two months later than that
reported in two studies of normally developing infants. These
authors noted that they did not have a sufficient number of
patients to evaluate the effect of other variables, such as unilateral or bilateral involvement.
The mean age at walking in the present study was higher
than that reported by Sala et al.7 (14.5 months compared with
13.9 months). This difference may be due to our inclusion of
patients who experienced an early relapse. In the present study,
patients who did not experience an early relapse walked at a
mean of 14.2 months.
We evaluated several patient variables that might affect
the age at which our patients began to walk (Table I). We found
no significant influence of sex, bilaterality, or a family history
of clubfoot. Similarly, Garcia et al.6 found no significant difference between infants with bilateral clubfoot and unilateral
clubfoot in terms of AIMS scores at any of the assessment
intervals in their study.
Our patients who were initially classified as having a very
severe deformity, based on the Dime glio classification, achieved
independent walking more than one month later than those
patients who had a moderate or severe deformity. This finding
contrasts with that of Garcia et al.6, who concluded that the
severity of the deformity at initial presentation, also assessed
with use of the Dime glio score, did not influence the attainment of motor skills.
Among the treatment variables we evaluated (Table II),
the number of casts applied prior to tenotomy, the need for a
heel-cord tenotomy, and noncompliance with the brace protocol
had no significant influence on the age at which the patients
began walking. However, infants who experienced an early relapse of the deformity began walking at an average of 1.7 months
later than those patients who did not experience a relapse. This
finding may be attributable to the need for additional cast applications and increased time in the postcorrective brace that was
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Lewis E. Zionts, MD
Shannon Cooper, BS
Edward Ebramzadeh, PhD
Sophia Sangiorgio, PhD
Orthopaedic Institute for Children,
403 West Adams Boulevard,
Los Angeles, CA 90007.
E-mail address: LZionts@mednet.ucla.edu
Davida F. Packer, MD
Department of Orthopaedics,
Miami Childrens Hospital,
3100 S.W. 62nd Avenue, Miami FL 33155
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