Introduction
The incidence of congenital talipes equinovarus (clubfoot) ranges from 1-3 per 1000 live births across the world. [1] Ponseti method has transformed the management of clubfoot in children producing good long-term results and in the last two decades has gained acceptance in the worldwide orthopaedic community.[2- 5]
The Conventional Ponseti method uses serial application of weekly above knee plaster casts to gradually correct the deformity, using a strictly defined sequence of molded plaster changes. The last deformity to be corrected is equines, which often requires a percutaneous tendo Achilles tenotomy followed by a final plaster. This final plaster is removed after three weeks and foot abduction braces are given to the child which are to be worn for twenty three hours per day for three months and thereafter for twelve hours at night, till the age of three years.
We run a clubfoot clinic at our hospital. The patients who come to our clinic often have to travel long distances for treatment. Transport facilities for these patients are often erratic and not always available. In addition, keeping a plaster clean and dry for a week can be challenging and failure to do so may result in a loss of position.
There is now strong evidence to suggest that accelerated frequency of cast changes has comparable outcomes to those of the conventional Ponseti method with the benefit of limiting the time spent is casts during the corrective phase of treatment. The researchers have modified the frequency of casting from weekly basis to as less as thrice a week and produced comparable results [6-8]. There is still very little published data about effectiveness of accelerated Ponseti technique in the Indian patients. We conducted this study to determine the feasibility and compare the results of accelerated and conventional Ponseti technique in idiopathic congenital clubfoot.
Methods
A prospective experimental randomized controlled trial was conducted from July 2014 to June 2015 in the clubfoot clinic at our tertiary care center. Forty cases with 53 clubfeet were taken up for the study. The International Guidelines for Biomedical Research involving Human Subjects issued by CIOMS, (Geneva 1982) were complied.
The Inclusion Criteria were;age less than three months, unilateral or bilateral idiopathic clubfoot and willingness to take part in the study while theExclusion Criteria were;age more than three months, earlier treated with other methods of
plaster cast application, earlier operated for clubfoot, concomitant major illness, atypical or secondary clubfoot and unwillingness to take part in the study.All the patients who fulfilled the inclusion criteria were registered in the clubfoot clinic for the study. Randomization was done using computer table and patients were allocated to one of the treatment groups either conventional or accelerated Ponseti casting.
All feet were scored using the Pirani method [9], recorded by an independent assessor at each visit. Successful correction was labeled as Pirani Score <1. Failure was labeled as Pirani Score >1 even after 8 corrective casts. A percutaneous tendo achilles tenotomy was performed if dorsiflexion was < 10° at the end of manipulation and plastering.
Both groups were put into plaster, following tenotomy, for three weeks. The defined endpoint of treatment for both groups, labeled ‘treatment time in plaster’ refers to the number of days in plaster prior to a tenotomy.
Both groups were given abduction braces to wear in accordance with the standard Ponseti program. All patients were treated as outpatients, thereby reducing any bias from altered compliance and enabling us to directly compare the efficacy of the two methods in terms of correction of the deformity. Follow-up was done at monthly intervals for six months.
We used Mann-Whitney U test to compare the data between the two groups, p-value < 0.05 was considered statistically significant.
Results
A total of 40 children (53 feet) with idiopathic clubfoot were recruited into the trial, 13 of whom were bilateral. Half the patients i.e. 20 children (27 feet) were allocated to the accelerated Ponseti group and the other half (26 feet) to the conventional treatment group. The two groups were demographically similar to each other (Table1).
The mean age of the children was 23.54+11.54 days in the accelerated group and 22.95+11.12 days in the conventional group.
There was no significant difference in the Pirani score of the groups, both before and after treatment (Table 2). Of the 40 patients, two were ‘not corrected’ (Pirani score > 1.0), one from the accelerated group and the other from the control group and they required a surgical procedure to achieve correction.
Variables | Conventional group | Accelerated Group |
---|
Number of patients | 20 | 20 |
Mean age of patients | 22.95+11.12 | 23.54+11.54* |
Number of males | 8 | 12 |
Bilateral involvement | 6 | 7 |
Number of feet | 26 | 27 |
Number of feet which required tenotomy | 20 | 20 |
Cases in which Treatment failed | 1 | 1 |
No of feet enrolled for further study | 25 | 26 |
*Not Significant
Table 1: Demographic characteristic of patients enrolled for study in two groups.
Follow-up in the accelerated group was for a mean of 233 days (70 to 348) and in the control group for a mean of 248 (25 to 346). There were no episodes of recurrence at six months. No complications due to casting were noted in any of the group.