The success of management with the Pavlik harness for

The success of management with the Pavlik
harness for developmental dysplasia of the hip
using a United Kingdom screening programme
and ultrasound-guided supervision
M. J. Walton,
Z. Isaacson,
D. McMillan,
R. Hawkes,
W. G. Atherton
From Bristol Royal
Hospital for
Children, Bristol,
United Kingdom
„ M. J. Walton, BMedSci,
BMBS, FRCS(Orth), Specialist
Registrar
„ Z. Isaacson, Medical Student
„ D. McMillan, MCSP,
GradDipPhys, Clinical
Specialist Physiotherapist
„ R. Hawkes, MBChB, MRCPch,
FRCR, Consultant Paediatric
Radiologist
„ W. G. Atherton, MA,
FRCS(Orth), Consultant
Paediatric Orthopaedic
Surgeon
Bristol Royal Hospital for
Children, Upper Maudlin
Street, Bristol BS2 8BJ, UK.
Correspondence should be sent
to Mr M. J. Walton; e-mail:
[email protected]
©2010 British Editorial Society
of Bone and Joint Surgery
doi:10.1302/0301-620X.92B7.
23513 $2.00
J Bone Joint Surg [Br]
2010;92-B:1013-16.
Received 30 September 2009;
Accepted after revision 11
March 2010
VOL. 92-B, No. 7, JULY 2010
We present the results of treatment of developmental dysplasia of the hip in infancy with
the Pavlik harness using a United Kingdom screening programme with ultrasound-guided
supervision. Initially, 128 consecutive hips in 77 patients were reviewed over a 40-month
period; 123 of these were finally included in the study. The mean age of the patients at the
start of treatment was five weeks (1 to 12). All hips were examined clinically and monitored
with ultrasound scanning. Failure of treatment was defined as an inability to maintain
reduction with the harness. All hips diagnosed with dysplasia or subluxation but not
dislocation were managed successfully in the harness. There were 43 dislocated hips, of
which 39 were reducible, but six failed treatment in the harness. There were four dislocated
but irreducible hips which all failed treatment in the harness. One hip appeared to be
successfully treated in the harness but showed persistent radiological dysplasia at 12 and
24 months. Grade 1 avascular necrosis was identified radiologically in three patients at
12 months.
The use of a Pavlik harness is an accepted
treatment for the management of instability in
developmental dysplasia of the hip (DDH),1,2
as it allows rapid remodelling of the acetabulum in the presence of a reduced femoral head.
It has been shown to be highly successful in
screening programmes, with a low rate of avascular necrosis (AVN).2 However, a recent publication from The Netherlands reported a
success rate of only 20% in Graf type IV hips,
and a rate of AVN of 16% at one year.3 The
principal difference between practice in
the United Kingdom and The Netherlands is
the time of initiation of treatment. In The
Netherlands the current national screening
programme identifies affected babies at
between three and five months of age, with a
mean age at the start of treatment of four
months. The current United Kingdom-based
screening programme recommends screening
for at-risk babies at six weeks.
We present our results of the use of the Pavlik harness in the management of DDH using a
United Kingdom screening programme and
ultrasound-guided supervision.
Patients and Methods
The study was carried out at a tertiary referral
paediatric orthopaedic unit between February
2004 and June 2007 (40 months). Patients
who were diagnosed with DDH through our
screening programme were enrolled. Patients
with teratological causes of hip dysplasia
were excluded, as were tertiary referral cases,
as these were generally patients who presented later with a potentially different natural history.
There were three routes of patient identification. Every child born at our institution
undergoes a mandatory clinical examination
of the hips, including the tests described by
Barlow4 of hip dislocation with a posterior
force in adduction and flexion, and by
Ortolani5 in which the hip is relocated with
an anterior force in abduction and flexion.
Any baby with an abnormal examination was
referred for ultrasound screening. A baby
with a frank dislocation was assessed by a
clinical specialist physiotherapist, put immediately into a Pavlik harness, and then
referred to the next available ultrasound
clinic, within two weeks. Any child born with
a normal clinical examination but with risk
factors for DDH including a positive family
history, breech presentation at delivery, a
lower limb deformity such as congenital
talipes equinovarus, scoliosis or severe oligohydramnios was referred for screening. Any
patient with an abnormal hip examination by
their general practitioner at six weeks was
referred to the next available combined ultrasound clinic.
1013
1014
M. J. WALTON, Z. ISAACSON, D. MCMILLAN, R. HAWKES, W. G. ATHERTON
Table I. Classification of avascular necrosis as defined by the Commission for The Study of the Hip9
Grade
Radiologic findings
Prognosis
1
Slightest degree of changes, femoral head ossification centre with
slightly blurred margins, slightly granular and irregular in structure
Generally regresses over time
2
More blurred margins of the ossification centre with irregular
structure, more granular than for grade 1. Also cyst formation or
punched out partial defects
Changes usually regress, possible
flattening of the head
3
Whole femoral head ossification centre disintegrated or only visible
as individual fragments or a flat strip. Very small head nucleus,
possibly completely broken up or only visible after many months
Frequent deformation of the femoral
neck initially, which regresses at a
later date
4
Additional involvement of the epiphyseal plate. Irregularities also
apparent on the margins of the epiphyseal plate at the femoral neck
Serious consequences for growth
The combined ultrasound clinic is run fortnightly with
a consultant paediatric orthopaedic surgeon and team, a
consultant paediatric musculoskeletal radiologist and a
clinical specialist physiotherapist. All babies undergo an
ultrasound and clinical examination at each visit.
The ultrasound measures the congruency of reduction
of the hip, the development of the acetabulum using the
Graf α angle6 and the stability of the hip under dynamic
screening.7
Hip dysplasia is defined as a Graf α angle of < 60°. Our
indication for management with a Pavlik harness is the
presence of instability or frank dislocation on dynamic
ultrasound scanning. Four groups of patients are therefore
identified: dysplasia without instability, a subluxable hip,
a dislocated hip which is clinically reducible, and a dislocated hip which is not reducible. During the period of
this study it was our practice to use a trial of the Pavlik
harness in all unstable hips.
The Pavlik harness was applied by the specialist physiotherapist in the position of maximum stability, as defined
by the ultrasound scan. This is with the anterior straps
holding the hips in 90° to 100° of flexion and the posterior
straps tightened to limit adduction to between 3 cm and
5 cm between the knees. Each baby is then seen at one to
two week intervals to check the harness, which is changed
to a larger size if required. Each baby has a repeat ultrasound two weeks after application of the harness to ensure
adequate reduction, and then four- to six-weekly to assess
acetabular development. The harness is removed when the
Graf α angle reaches > 60° and the hip is stable to dynamic
ultrasound examination. Failure is defined as the inability
of the harness to achieve or maintain concentric reduction, or failure of acetabular development despite concentric reduction.8
After removal of the harness each baby was followed up
clinically and radiologically at 12 months and for a minimum of two years. The radiographs were reviewed independently by two observers (MJW, WGA). AVN was
assessed using the scoring system described by the Commission for Study of the Hip (Table I)9 and acetabular
development using the acetabular index.
Results
Initially, 128 hips in 77 patients were included in the study.
There were 73 left hips and 55 right with bilateral disease in
51 patients. In 12 hips identified at birth an initial ultrasound assessment was not undertaken. The remaining hips
were identified at between four and 12 weeks of age in the
combined ultrasound screening clinic, and a Pavlik harness
was applied at a mean of five weeks (1 to 12).
Four hips were initially treated successfully with a Pavlik
harness, but treatment was abandoned due to failure of the
Pavlik harness to maintain a concentric reduction of the
contralateral hip and they were therefore excluded. One hip
with a reducible dislocation appeared to have successful
treatment but showed persistent acetabular immaturity on
subsequent radiological follow-up, and was also excluded
from the analysis. There were 64 subluxatable hips in the
presence of dysplasia (mean Graf α angle = 52°, 43° to 59°),
and 43 dislocatable hips (mean Graf α αngle = 45°, 34° to
52°). In 16 patients with bilateral disease, the milder of the
two hips showed evidence of dysplasia (mean Graf α angle
= 54°, 52° to 59°) but no instability on the dynamic ultrasound scan. Although, in our practice this type of hip is
routinely treated by serial observation and ultrasound scan,
in view of the significant contralateral dysplasia they were
managed with a Pavlik harness and therefore included in
this study.
Following the exclusion of five of the 128 hips initially
entered in the study, 111 of 123 hips (90%) were managed
successfully with a Pavlik harness. There were 12 failures
in nine patients (10%) owing to inability of the harness to
achieve or maintain concentric reduction of the hip. The
mean initial Graf α angle in the successful group was 52°
(34° to 59°) and 44° (38° to 52°) in the group that failed. All
12 failures occurred in the group of 43 dislocated hips, eight
of which were clinically reducible (mean Graf α angle = 46°,
39° to 52°) and four initially clinically irreducible (mean
Graf α angle = 42°, 30° to 45°). All of these latter four
failed treatment with the harness. In three we were unable
to achieve concentric reduction, and one became reducible
after two weeks in the harness, but the reduction could not
be maintained. Of the 12 hips that failed treatment with a
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THE SUCCESS OF MANAGEMENT WITH THE PAVLIK HARNESS FOR DEVELOPMENTAL DYSPLASIA OF THE HIP
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Table II. Summary of outcome
Mean α
Number angle
Dysplasia without instability
(range)
Subluxatable (range)
Dislocated but reducible
Dislocated and irreducible
Total
Persistent
Mean age at start of Mean duration of
Avascular acetabular
treatment (wks)
treatment (wks) Treatment success (%) necrosis dysplasia
16
54 (52 to 59)
5 (1 to 12)
10 (6 to 16)
16 (100)
0
0
64
39
4
123
52 (43 to 59)
46 (34 to 53)
42 (38 to 45)
6 (1 to 12)
3 (1 to 12)
2 (1 to 2)
11 (6 to 16)
12 (6 to 16)
2 (abandoned)
64 (100)
31 (79)
0 (0)
0
2
1
0
1
0
Pavlik harness, 11 were treated with an adductor tenotomy
followed by closed reduction and one required open reduction by the medial approach. All were then managed in a
hip spica for three months (Table II).
The ultrasound scans of all the dislocated hips (n = 43)
were reviewed retrospectively and formally graded by a
consultant paediatric radiologist (RH) using the Graf scoring system.6 There were 29 Graf III and 14 Graf IV hips. Of
the 39 hips defined as reducible, 27 were Graf III and
12 Graf IV. Of the irreducible dislocations two were Graf
III and two Graf IV. Treatment with the harness was successful in 23 but failed in six, a success rate of 79%. Treatment with the harness was successful in eight Graf IV hips
and failed in six, a success rate of 57%.
The predictive value of Graf grade and ultrasound scan
reducibility was then assessed. The positive predictive value
(i.e. the chance of successful treatment with the Pavlik harness) of both reducibility on ultrasound prior to treatment
and a Graf III classification was 0.79. The negative predictive
value (i.e. likelihood of failure) of irreducibility on ultrasound was 1 (sensitivity 1, specificity 0.66) compared to Graf
IV classification of 0.43 (sensitivity 0.74, specificity 0.5).
At radiological review, three hips (2% overall, 7% of dislocated hips) were identified on the 12-month radiograph
as having potential AVN (Table II). All three were classified
as grade 1 by both reviewers. Treatment with the Pavlik
harness had been successful in two of the hips with potential AVN. Both patients had bilateral disease, and in both
the worst hip was affected. Both had been dislocated but
reducible (one Graf III, one Graf IV) on ultrasound scan
examination. The third hip with potential AVN was an irreducible dislocation (Graf IV). This hip failed treatment with
the harness and required an adductor tenotomy and management in a hip spica. All three hips are asymptomatic at
present and are being managed conservatively.
Acetabular maturation was assessed radiologically using
the acetabular index (AI). All hips that were successfully
treated with the harness are maturing satisfactorily with the
AI in the normal distribution, as defined by Tonnis and
Brunken,10 of at 12 months < 22°, and 24 months < 19°,
except one. This hip appeared to have been successfully
treated with the harness but showed persistent acetabular
immaturity on radiological follow-up at 12 months with an
AI of 27°. The patient underwent an examination under
VOL. 92-B, No. 7, JULY 2010
anaesthesia and hip arthrography at 24 months of age,
which demonstrated a concentrically reduced hip with no
instability. The AI is improving (25°) and she continues to
be managed conservatively. None of the nine patients (12
hips) who failed management in the harness and required
adductor tenotomy or open reduction have required further
surgical treatment. Acetabular maturation in this group is
delayed compared to normal, with a mean AI of 22° (19° to
27°) at 24 months, although this continues to improve on
serial radiographs.
Discussion
The use of a selective hip screening programme in infancy
has been shown to be an acceptable and cost-effective
method of treating DDH.11-13 The main principle of management is to maintain concentric reduction of the hip
during the period of early acetabular development. Many
devices have been used to hold the hips in a flexed and
abducted position. The Pavlik harness is the most common form of splintage and is in widespread use throughout Europe and the United States. We believe that this
study demonstrates that treatment with the harness can
be successful and has few complications when applied
early in the natural history of the disease. Our results are
in keeping with those of other series using a similar protocol.2,14,15 However, other devices, such as the von
Rosen splint, have also been shown to be successful.16,17
It has been suggested that the more rigid splintage offered
by the von Rosen splint may be more successful than the
Pavlik harness in the management of severe DDH, but
so far no formal randomised controlled trial has been
conducted.
In this study there were a relatively high number of
mildly affected hips, in particular the group with ultrasound dysplasia without instability. All of these were in
infants with bilateral hip dysplasia and involved the milder
affected hip. They were therefore included in the study. The
management of dysplasia without instability is variable and
its benefit questionable.18 All of these hips in our study
were successfully managed with a Pavlik harness, but we
accept that they are a group which is likely to have done
well despite treatment. Our current practice is to manage
dysplastic hips without instability by observation and serial
ultrasound to ensure satisfactory development.
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M. J. WALTON, Z. ISAACSON, D. MCMILLAN, R. HAWKES, W. G. ATHERTON
In this study the success rate for treatment of subluxatable hips with the Pavlik harness was 100%. All 12 failures
(10%) occurred in patients with dislocation of the hip. These
were divided into two groups: those that were clinically
reducible on ultrasound scan prior to management, and
those that were irreducible. We do not routinely use the Graf
grading system for our patients at hip ultrasound scan. This
study has shown that the relatively simple demonstration of
reducibility on the ultrasound scan has at least the same positive predictive value as a Graf III classification. Our success
rate in this group would be higher than demonstrated, as we
did not retrospectively review and grade the subluxable hips
group using the Graf scoring system within which there
might have been a number of Graf III hips. The diagnosis of
irreducibility was a better predictor of failure than a Graf IV
classification. The 100% failure rate in hips that present initially as irreducible is similar to the findings of Lerman et
al.19 We therefore no longer attempt treatment with a Pavlik
harness in the irreducible group, and instead proceed
directly to closed reduction under anaesthesia.
There was a trend in this study for failure of treatment
with the Pavlik harness to be associated with increasing
instability and a decreasing Graf α angle. The degree of dysplasia as measured by the Graf α angle in the failure group
was also seen in patients whose treatment was successful.
The degree of dysplasia did not, therefore, appear to be an
independent predictor of failure.
The reported statistical significance of the association
between the timing of diagnosis and start of treatment and the
success of management with the Pavlik harness is variable.19,20
However, there is a difference between this study, where the
mean age at the start of treatment was five weeks (1 to 12) and
those where the mean age at the start of treatment was four
months. The difference was most apparent in the most
severely affected Graf IV hips. Our success rate (57%) in this
group was lower than in milder disease, but contrasts with the
20% reported by van der Sluijs et al.3 The AVN rate of 16% at
one year observed in that series3 is also higher than in ours and
many other studies.2,14,15,21 This more severely affected group
of patients would appear to benefit from earlier diagnosis and
treatment, which we believe can improve the initial outcome
and lead to a potential reduction in longer term complications.
We continue to recommend treatment with the Pavlik harness for infants with DDH in conjunction with an early
screening programme. Parents may be reassured that the outcome in the presence of a subluxated hip is almost universally
good. The dislocated but reducible hip remains a greater challenge. When diagnosed early, treatment with the Pavlik harness still has a 79% success rate and a low rate of AVN.
However, we no longer recommend treatment with a Pavlik
harness for the irreducible hip, as this was unsuccessful in this
series and may delay more appropriate treatment.
No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.
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