Full length articlePonseti method is superior to surgical treatment in clubfoot – Long-term, randomized, prospective trial
Introduction
The primary treatment of clubfoot deformity has evolved from full surgical correction to less invasive methods over the past twenty years. Comprehensive surgical release was the standard of care and is still used when the primary nonoperative management of clubfoot fails. Surgical treatment provides satisfactory clinical and radiological results; however, long-term follow-up results, based on clinical examinations, questionnaires, radiographic analyses and gait kinematics, are disappointing [1], [2]. Moreover, adolescents who undergo a corrective surgery of clubfeet as infants present with residual pain, decreased strength and functional deficits compared with typically developing children [1]. The manipulation technique described by Ignatio Ponseti [3] has shown to be superior to surgical treatment in several retrospective studies [4], [5] and has changed our approach to the treatment of clubfoot deformity. The Ponseti method is a safe and effective treatment approach for clubfeet and decreases the need for extensive corrective surgery [6]. Although prospective studies [7], [8] and studies with a mid- [9] and long-term follow-up [7], [10] have been conducted, no randomized prospective trials comparing the long-term follow-up of Ponseti with surgical treatment have been reported. Therefore the favorable long-term outcomes of the Ponseti casting technique need to be evaluated in a prospective and randomized manner.
In 2001, a prospective, single center, randomized, and controlled trial with parallel design comparing both methods was started at our institution; the short-term results have been already published [8]. The aim of the present paper was to compare the long-term outcomes of the Ponseti method with surgical treatment in terms of gait, function, morphology and quality of life. We hypothesized that, compared with the surgical group, the Ponseti group would have better in Functional Rating System (FRS) scores, less limited ankle range of motion based on clinical measurements and the Oxford Foot Model (OFM) and superior results on the parent reported Pediatric Outcome Data Collection Instrument (PODCI).
Section snippets
Methods
The trial was set up at as an intention-to-treat analysis (Fig. 1) at a time when the primary surgical correction was the current standard approach at our institution. We included only otherwise healthy infants younger than 2 weeks of age with no other congenital deformities. Newborns with perinatal problems or suspicion of neurologic or metabolic disorders were excluded. Parents were informed in detail about the study itself and both therapy regimes and provided written informed consent to
Treatment protocols
In the Ponseti group, clubfeet were treated at weekly intervals with a manipulative technique and an above knee cast as described by Ponseti [3] followed by percutaneous Achilles tenotomy and a final cast for three weeks. Orthotic management was started as soon as the correction was achieved. All patients were managed with an abduction brace with an external rotation of 70° for the clubfoot and 45° for the healthy foot in unilateral cases. The orthotic device was discontinued when the patient
Statistical analysis
A Mann-Whitney-U test was used to compare the results between the study groups. The independence of categorical variables was analysed using a Chi-square test, and p values <0.05 were considered statistically significant.
Results
The two treatment groups were comparable in terms of Pirani score at birth (p = 0.618), sample size, and age (Table 1). For the long-term analysis nine children (12 clubfeet) were examined in the Ponseti group and seven children (12 clubfeet) in the surgical group. The average follow-up time was 9.8 years (SD 0.6), which was not statistically different between groups (p = 0.976). In addition, no relationship was found between the treatment groups in relation to gender (Chi-square 3.56; p = 0.059) or
Discussion
Even though Ponseti developed his technique of conservative clubfoot treatment in the 1940s and published the early results in 1963 [3] it still took a half a century for his method to become widespread among paediatric orthopaedic surgeons. In the U.S. the percentage of clubfeet surgically treated dropped from 70% in 1996 to 10% in 2006 [23]. The main reason for this drop is probably the increasing evidence in the literature from mid-and long-term [4] studies showing the superior outcomes of
Limitations of the study
This study did have several limitations. Most importantly, the local ethics committee halted the recruiting process because the interim report indicated that more additional surgical procedures other than simple tenotomies were needed to achieve the primary correction in the surgical group. In accordance with the judgment of the local ethical committee, it was considered unethical to use this method with new patients. Therefore the planned sample size of 23 clubfeet per treatment group as well
Conclusion
This long-term, prospective, randomized, comparative study showed that the Ponseti method was superior to surgical treatment in idiopathic clubfeet. Based on better morphology, function, and radiological outcomes as well as the better overall health and increased ability of patients to participate in activities of daily living, the Ponseti method appears to be a low cost low-tech treatment available for the widest spectrum of patients.
Conflict of interest
None.
Acknowledgement
One or more of the authors (TK) has received funding from Land Steiermark, Graz, Austria.
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