512 Original article

Ponseti treatment for clubfoot in Romania: a 9-year single-centre experience Dan I. Cosma and Dana E. Vasilescu Manipulation and casting according to the Ponseti method are the ‘gold standard’ for clubfoot treatment, and this method is endorsed by the American Association of Orthopaedic Surgeons. We conducted a retrospective study from January 2004 to December 2012 in our institution. All patients with idiopathic clubfoot were included, and a very strict analysis of the treatment outcomes, relapses and their treatment was carried out. A total of 382 children were included and followed up for a mean period of 6 years. The initial correction rate was 100%. At latest follow-up, the relapse rate was 19.03%, the initial correction being recovered by recasting, second or third percutaneous Achilles tenotomy or anterior tibial tendon lateral transfer. The Ponseti method is safe, efficient in the conservative

Introduction Clubfoot is a complex foot malformation that occurs separately from other bone and joint malformations [1,2]. Congenital clubfoot is the seventh most common congenital birth defect and the most common of the musculoskeletal system, affecting one per 1000 live births per year [1]. In 1996, in the USA, 2224 newborns with clubfoot were reported – that is, an incidence at birth of 0.6% [2]. Ponseti considers that every year, in the world, more than 100 000 children are born with clubfoot [3]. Quite a large percentage of the mentioned cases occur in developing countries and the majority remain untreated or are improperly treated leading to physical, social, psychological and financial issues for the patients, their families or the society. In the world, the neglected clubfoot is the most often occurring case of physical disability due to the bone and joint congenital malformations [4,5]. All orthopaedists agree that the initial treatment should be nonsurgical and initiated immediately after birth [6–8]. The aim of the treatment consists in correcting all the foot deformities (equinus, varus, cavus and forefoot adduction) to achieve a plantigrade foot and enabling the patient to wear usual shoes and to prevent arthritic degenerations in adulthood. Beginning in the 1950s, Ponseti developed a nonsurgical corrective method for clubfoot [9]. This method requires weekly manipulations, followed by long-leg cast immobilizations. Usually, after 4–5 weeks, all the deformations are corrected, except for the equinus. More than often, to remedy the last-mentioned deformation, it is necessary to practice the percutaneous Achilles tenotomy (pAT). 1060-152X © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins

treatment of clubfoot and decreases the number of surgical interventions, and the very good results are maintained through a 9 years follow-up period. J Pediatr Orthop B 23:512–516 © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Journal of Pediatric Orthopaedics B 2014, 23:512–516 Keywords: clubfoot, Ponseti method, relapse Department of Paediatric Orthopaedics, University of Medicine and Pharmacy ‘Iuliu Haţieganu’, Cluj-Napoca, Romania Correspondence to Dan I. Cosma, MD, PhD, Department of Paediatric Orthopaedics, University of Medicine and Pharmacy ‘Iuliu Haţieganu’, 46–50 Viilor St., 400347 Cluj-Napoca, Romania Tel: +4 0264 207021; fax: +4 0364 814344; e-mail: [email protected]

The clinical correction achieved by this method led to a functional, plantigrade foot, where the posteromedial release (PMR) was no longer necessary in 89% of the patients. Good results were maintained in 78% of the patients in a follow-up interval of 30 years [10]. With the making of the Ponseti method more known, more studies have been carried out for its results assessment. Morcuende et al. [2] noticed a diminishing number of cases that required ample surgical operations in their study group. Morcuende had positive results in 98% of cases, with an 11% recurrence rate, mainly because of noncompliance with the Denis–Browne orthoses. Although the awareness and use of the Ponseti method for the treatment of clubfoot have increased, only a few studies outside Iowa present mid-term results of treatment with favourable results [11]. Our first paper published in 2007 described the shortterm results of an initial 51 patients (74 feet) series treated by the Ponseti method. The results were very encouraging (95% correction rate) and the method has been popularized and adopted across the country [12]. In this study, our aim was to evaluate the results of the Ponseti method in the treatment of clubfoot in our institution through a longer period (9 years), analysing the relapses and their treatment.

Patients and methods We selected from our database all patients with idiopathic clubfoot treated in our institution by the Ponseti method since January 2004. The inclusion criteria in the DOI: 10.1097/BPB.0000000000000081

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Nine-year experience in clubfoot treatment Cosma and Vasilescu 513

present study were idiopathic bilateral or unilateral clubfoot, without other congenital foot deformity, deformity not treated previously by open surgery and children treated in the interval between January 2004 and December 2012. The exclusion criteria of the study were neurological clubfoot, other syndromes associated (arthrogryposis, myelodysplasia, etc.) and postural clubfoot (correction with less than three casts [11]). We obtained informed consent of the parents of patients before being included into the study and the research was approved by the local ethical committee. The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki. Our study group consisted of 382 children (562 feet) treated and followed in the interval 2004–2012. The mean follow-up period was 6 years (range 6 months to 9 years). Of 382 patients, 232 patients were boys and 150 patients were girls with a male-to-female ratio of 1.54, and 180 patients had bilateral involvement, whereas 202 had unilateral clubfeet (108 right clubfoot and 94 left clubfoot). The mean age at the beginning of the treatment was 4.03 months (range 1 week to 13 years). In all, 103 children were above 6 months of age at the beginning of the treatment, whereas 11 were above 4 years of age. A total of 102 children had previous ineffective orthopaedic treatment. Children demographical data were collected: age at the beginning of treatment, sex and laterality of the deformity. All feet were evaluated at presentation using the Pirani score. The Ponseti method was strictly used as described by the authors. The details of treatment were also noted: number of casts before tenotomy, timing and rate of pAT. We did not perform extended articular open surgery in any case, but in children above 4 years of age at the beginning of treatment (11 of 382 patients) we performed also the anterior tibial tendon lateral transfer (ATTLT) simultaneously with the pAT (Fig. 1). The ATTLT was performed under general anaesthesia, with the patient lying supine, and the tendon was passed under the extensor retinaculum and fixed to the lateral cuneiform through a tunnel. Except these cases, where we did not recommend foot abduction braces (FABs), all other patients were put in FABs immediately after removal of the last cast full-time for 3 months, followed by night and nap-time periods up to the age of 4 years. The follow-up protocol scheduled a monthly visit in the first 3 months after removal of the last cast, a quarterly visit up to the age of 1 year, a half-yearly visit up to the age of 2 years and then a yearly evaluation. Clinical evaluation at the follow-up visits included passive range

of dorsiflexion (measured by goniometer), signs of recurrence (heel varus, forefoot adduction) and gait (with special attention for dynamic adduction).

Results A total of 382 children treated exclusively by the Ponseti method passed the inclusion criteria. Pirani score before treatment ranged from 4 to 6 with a mean value of 4.9. The annual distribution of the patients according to the number of casts for full correction and the rate of tenotomy was presented (Table 1). The overall mean number of casts for full correction was 5.42, whereas the overall tenotomy rate was 91.63% (515 feet of 562). The initial correction was obtained in all cases (100%). At the first quarterly visit (3 months after the 3 months fulltime brace using period), the mean ankle dorsiflexion with the knee fully extended was 11.20° (range 0–29°), and we did not notice any sign of recurrence (loss of dorsiflexion, heel varus, foot adduction) (Fig. 2). At later follow-ups, we noticed the relapse in 107 feet of 562 (19.03%). The initial correction was recovered with the use of serial casts according to the Ponseti technique and second pAT in 67 feet (62.61%), recast and third pAT in eight feet (7.47%) and recast, pAT and ATTLT in 32 feet (29.92%). Distribution of the relapsed feet according to the age was given (Fig. 3). No major complications were noted. We did not encounter any serious bleeding following tenotomy, any wound problems with percutaneous incision nor any allergic reaction to the padding material or cast.

Discussion Our study presents one of the largest series of clubfoot patients treated by the Ponseti method. The study group is homogenous regarding the aetiology of clubfoot (idiopathic), but it is not very homogenous regarding the age of patients. Our follow-up period of 6 years is comparable with those reported by Radler et al. [11] and Porecha et al. [13]. They reported initial correction rates of 95 and 100%, respectively, whereas our correction rate in such a series was 100%. The Ponseti method was developed and described by Ignacio Ponseti at the University of Iowa in 1950 for the conservative treatment of clubfoot, in an attempt to achieve a functional, plantigrade foot, without resorting to surgery [14]. The long-term results of the method have shown positive values in 85–90% of the cases, if the method was rigorously applied [3,10,15]. Currently, manipulation and casting according to the Ponseti method are the ‘gold standard’ for clubfoot treatment and this method is endorsed by the American Association of Orthopaedic Surgeons. With the making of the Ponseti method more known, more studies have been carried out for its results

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514 Journal of Pediatric Orthopaedics B 2014, Vol 23 No 6

Fig. 1

(a) Right neglected clubfoot in a 13-year-old boy; (b) after pAT and ATTLT performed under general anaesthesia, before putting the last cast; (c) at 6 weeks’ follow-up after removal of the last cast. ATTLT, anterior tibial tendon lateral transfer; pAT, percutaneous Achilles tenotomy.

Annual distribution of mean number of casts and percutaneous Achilles tenotomy rate

Table 1

2004–2005 2006 2007 2008 2009 2010 2011 2012 Overall

Number of patients

Mean number of casts

pAT rate (%)

51 31 36 58 41 57 57 51 382

4.1 5.9 6.1 4.8 6.1 5.7 5.5 5.2 5.42

75.17 76.31 79.54 90.90 94.73 94.93 93.58 94.87 91.63

pAT, percutaneous Achilles tenotomy.

assessment. Morcuende and colleagues noticed the diminishing number of cases that required ample surgical operations in their study group. Morcuende et al. [2] had positive results in 98% of cases, with an 11% recurrence rate, mainly due to noncompliance with the Denis–Browne orthoses. Finally, 2.5% needed PMR and 2.5% needed transfer of the anterior tibial tendon.

Herzenberg et al. [8] have found that PMR was necessary for one foot of 34 studied, as compared with the control group where 32 of 34 feet necessitated PMR. Lehman et al. [7] assessed the early results with his patients and had positive results with the children below 7 months of age who also used the Denis–Browne orthoses according to the medical recommendations. Ippolito et al. [6] observed long-term favourable results in the Ponseti group as compared with the control group, where other methods were used. Cooper and Dietz [10] showed that the percutaneous Achilles’s tendon tenotomy is a benign procedure that does not induce long-term muscular strength negative effects. The tenotomy rate during the first years of practice that represented our learning curve increased from 75 to 95%. Other authors reported similar tenotomy rates among their series: Radler et al. [11] (96%) and Porecha et al. [13] (96%). In centres reporting the initial results of the Ponseti treatment, the tenotomy rate is lower: Sætersdal et al. [16] (79%), Matuszewski et al. [17] (75%). These

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Nine-year experience in clubfoot treatment Cosma and Vasilescu 515

Fig. 2

(a) Bilateral clubfoot in a 6-week-old girl before treatment; (b) correction is maintained at 1-year follow-up and (c) at 7-year follow-up.

Fig. 3

Distribution of recurrences (number of feet) according to the age.

relapse rate was 19.03%, comparable with those reported earlier by Radler et al. [11] (25%) during the comparable follow-up period. The rate of ATTLT is 5%, similar to those reported earlier. We noticed that most of the relapses were encountered in the 1–4 years of age interval, during the period of FABs, when the compliance rate to the FABs is 60%, explaining the relapses after the walking age when the correction required recasting and repeat of the extra-articular surgical procedures such as pAT and/or ATTLT. We consider that more efforts are necessary to establish a good relationship with the parents and to explain very well the role and the importance of wearing braces. The best treatment for relapses is prevention, and brace wearing is the best prevention. Compliance can be ensured by supporting the parents and, especially, by regular follow-ups.

data confirm our supposition that the tenotomy rate is lower at the beginning of practice and increases during the learning curve to a value around 95%.

Longer follow-up will most likely increase the rate of ATTLT, which was performed in our series at a younger age (4 years) and mainly represents our learning curve with the Ponseti management of relapse, but not the rate of open joint surgery.

Ponseti method is a method for treating deformity, preventing relapses and treating relapses. In our series, the

The Ponseti method is safe, efficient in the conservative treatment of clubfoot and decreases the number of

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surgical interventions needed for the correction of the deformation. In addition, it can be applied successfully to all infants who have or have not been subjected to previous conservative treatments.

Acknowledgements D.I.C. was supported by the Cluj-Napoca University of Medicine and Pharmacy’s grant for young researchers no. 27020/16/15.11.2011. Conflicts of interest

D.I.C. has received a grant (27020/16/15.11.2011) from the University of Medicine and Pharmacy ‘Iuliu Haţieganu’, Cluj-Napoca, Romania. D.E.V. have no conflicts of interest.

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Ippolito E, Farsetti P, Caterini R, Tudisco C. Long-term comparative results in patients with congenital clubfoot treated with two different protocols. J Bone Joint Surg Am 2003; 85-A:1286–1294. Lehman WB, Mohaideen A, Madan S, Scher DM, Van Bosse HJ, Iannacone M, et al. A method for the early evaluation of the Ponseti (Iowa) technique for the treatment of idiopathic clubfoot. J Pediatr Orthop B 2003; 12:133–140. Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop 2002; 22:517–521. Ponseti IV, Smoley EN. Congenital clubfoot: the results of treatment. J Bone Joint Surg Am 1963; 45:261. Cooper DM, Dietz FR. Treatment of idiopathic clubfoot. A thirty-year followup note. J Bone Joint Surg Am 1995; 77:1477–1489. Radler C, Mindler GT, Riedl K, Lipkowski C, Kranzl A. Midterm results of the Ponseti method in the treatment of congenital clubfoot. Int Orthop 2013; 37:1827–1831. Cosma D, Vasilescu DE, Vasilescu D, Valeanu M. Comparative results of the conservative treatment in clubfoot by two different protocols. J Pediatr Orthop B 2007; 16:317–321. Porecha MM, Parmar DS, Chavda HR. Mid-term results of Ponseti method for the treatment of congenital idiopathic clubfoot – (a study of 67 clubfeet with mean five year follow-up). J Orthop Surg Res 2011; 6:3. Jowett CR, Morcuende JA, Ramachandran M. Management of congenital talipes equinovarus using the Ponseti method: a systematic review. J Bone Joint Surg Br 2011; 93:1160–1164. Laaveg SJ, Ponseti IV. Long-term results of treatment of congenital club foot. J Bone Joint Surg Am 1980; 62:23–31. Sætersdal C, Fevang JM, Fosse L, Engesæter LB. Good results with the Ponseti method: a multicenter study of 162 clubfeet followed for 2–5 years. Acta Orthop 2012; 83:288–293. Matuszewski L, Gil L, Karski J. Early results of treatment for congenital clubfoot using the Ponseti method. Eur J Orthop Surg Traumatol 2012; 22:403–406.

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Ponseti treatment for clubfoot in Romania: a 9-year single-centre experience.

Manipulation and casting according to the Ponseti method are the 'gold standard' for clubfoot treatment, and this method is endorsed by the American A...
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