Clinical Efficacy of Ponseti Management for Idiopathic Clubfoot during the Neonatal Period A Single Center Study in China

Size: px

Start display at page:

Download "Clinical Efficacy of Ponseti Management for Idiopathic Clubfoot during the Neonatal Period A Single Center Study in China"

Kelley Malone
5 years ago
Views:

1 Research Article imedpub Journals Journal of Trauma and Orthopedic Nursing Clinical Efficacy of Ponseti Management for Idiopathic Clubfoot during the Neonatal Period A Single Center Study in China Yu-Bin Liu, Song-Jian Li, Li Zhao*, Bo Yu, Da-Hang Zhao and Xiang Zhao Department of Orthopaedics, Ying-Hua Medical Group of Bone and Joint Healthcare in Children Shanghai, Shanghai, China *Corresponding author: Li Zhao, Department of Orthopaedics, Ying-Hua Medical Group of Bone and Joint Healthcare in Children Shanghai, Shanghai, China, orthzl@126.com Received date: March 16, ; Accepted date: April 9, ; Published date: April 12, Citation: Liu YB, Li SJ, Zhao L, Yu B, Zhao DH, et al. () Clinical Efficacy of Ponseti Management for Idiopathic Clubfoot during the Neonatal Period A Single Center Study in China. J trauma Orth Nurs Vol.2 No.1: 2. Copyright: Liu YB, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract using repeated Ponseti management for the relapsed clubfoot. Background: There are great difference in the geographical region, race and ethnicity among reported epidemiological studies with the morbidity of clubfoot from 0.39/1000 to 8 per Published papers have reported the primary results of Ponseti management for clubfoot in different countries. However, no studies have reported as to the primary result of Ponseti management for idiopathic clubfoot in China. This study aimed to evaluate the clinical efficacy of Ponseti management of neonatal idiopathic clubfoot in China with a mean follow-up of 4.3 years. Methods and findings: The medical charts were reviewed between October 2007 and July A total of 90 patients, 69 boys and 21 girls, with 136 clubfeet met the inclusion and exclusion criteria. The patients were followed at the mean interval of 4.3 years (3 to 8 years). The complete correction was obtained initially in all the cases (100%), requiring mean numbers of 3.8 (2 to 7) casts. The procedure of percutaneous Achilles tenotomy (PAT) was required in 124 clubfeet (91.2%). The relapse of clubfoot deformity was identified in 21 of 136 (15.4%) feet at the mean age of 37.5 (11 to 60) months old. Relapse was presented in 10 feet as equinus and adductus, which was followed by the deformity of adductus in 8 feet. The treatment of relapsed deformity required the mean numbers of 3.9 (2 to 9) casts while repeated PAT procedure was required in 2 feet (1 patient). Conclusions: It is demonstrated that Ponseti method is of critical efficacy in treating idiopathic clubfoot during the neonatal period. Good clinical outcome can be obtained Keywords: Ponseti method; Idiopathic; Clubfoot; Followup Introduction Congenital clubfoot is one of the most common congenital musculoskeletal abnormalities in childhood which mainly affect the lower limb and characterized by four components: equinus, adductus, varus, and cavus [1-3]. The precise etiology and pathogenesis of this deformity remain unclear and numerous hypotheses have been reported such as neuromuscular, bone, connective tissue and vascular factors [4]. Epidemiological studies reported the incidence of 0.39 per 1000 live births in Chinese population, one to five per 1000 in Caucasians, and six to eight per 1000 in Polynesians [5]. This indicates that the morbidity of clubfoot vary with geographical region, race and ethnicity [6]. A descriptive epidemiological study from China reported that the prevalence of congenital clubfoot was about 5.12/104 with regional and gender differences in China [7]. Since Ponseti method was firstly introduced to our medical center in 2005, approximately 50 to 70 clubfoot cases per year were treated using Ponseti method. Ponseti method consists of serial specific manipulations and casting along with or without a procedure of Achilles tenotomy, followed by the use of a foot abduction orthosis (FAO) to maintain the correction approximately for 4 years [8]. As reported in the literatures, the Ponseti technique has shown good short-term and long-term outcomes [9,10] and radically reduced the rate of extensive surgery [3]. However, the inconsistent results were reported in different medical centers, including initial correction rate of 95%~100% [3,11,12] brace non-compliance rates of 23%~61% [2,13,14] and relapse rates of 14%~41% [15,16]. For exploration of the inconsistent results, we conducted an systemic review and found that the inconsistent results reported in the published papers may be attributed to the result of deviations from the details regarding manipulation, casting, the procedure of percutaneous Achilles tenotomy (PAT), the brace types, and Under License of Creative Commons Attribution 3.0 License This article is available from: 1

2 management protocols for relapsed cases [1]. Published papers have reported the primary results of Ponseti management for clubfoot in different countries, such as Nigeria [17], in Harare [18], in Norway [19], and so on. To our knowledge, no studies have reported as to the initial result of Ponseti management for idiopathic clubfoot in China. As the largest developing country around the world, there was lack of data on primary results of Ponseti management for clubfoot, and which present great challenges to implementation China Ponseti Program of distributing the Ponseti method. This study aimed to evaluate the clinical efficacy of Ponseti management of neonatal idiopathic clubfoot, which was conducted in our center, one of the largest treatment centers in China with a mean follow-up of 4.3 years. Methods We reviewed the charts from our database including all the patients with idiopathic clubfoot treated in our center using Ponseti method during the period between October 2007 and July All the clubfoot cases were treated by a single orthopedist. The inclusion criteria for the present study were as follows: 1) definitely diagnosed as idiopathic clubfoot; 2) age at presentation younger than 6 months old; 3) no history of previous treatment; 4) follow-up duration more than 3 years. Patients were excluded from this study due to the following reasons: 1) diagnosed as postural, neurological or syndromic clubfoot, or clubfoot with other associated deformities, 2) older than 6 months of age at presentation, 3) received previous management and 4) follow-up duration less than 3 years. Informed consent was obtained from all the parents. This study was approved by the institutional ethics committee. In this study, we strictly followed the protocol outlined in Ponseti method. This involved core principles and technical details of manipulation and casting, percutaneous Achilles tenotomy (PAT), brace type, brace protocol and relapse management. All the patients were treated without either anesthesia or sedative. All the deformities were corrected simultaneously. The technical issues were: 1) Ponseti method is initiated for the treatment of clubfoot soon after birth; 2) cavus is corrected at the first maneuver by elevating the first ray of the foot; 3) to abduct the forefoot while applying counter-pressure against the lateral aspect of the head of the talus; 4) heel varus is corrected when the entire foot is fully abducted; 5) abduction of the forefoot is increased progressively; 6) in the last cast, the foot should be markedly abducted to 60 to 70 without pronation; 7) residual equinus, defined as less than 15 of ankle dorsiflexion, is usually treated with PAT; 8) post PAT long-leg cast is applied for three weeks allowing the healing of the sectioned Achilles tendon; 9) when the full correction is achieved, brace is used to maintain the foot at 60 to 70 abduction on the affected side and 30 to 40 on the normal side; 10) our bracing protocol is full-time use for the first 3 months, then 16 to 18 h until the patient is 2-year old, then 14 to 16 h until the end of 4 years old; 11) relapse is treated with repeated manipulation and casting with or without PAT; 12) tibialis anterior tendon transfer (TATT) to the third cuneiform is performed in case with dynamic supination of the forefoot during swing phase of the gait;13) The importance of brace-wearing should be stressed to the parents at the beginning of treatment and an internet-based platform created by the physicians to introduce the Ponseti method is of great necessity for better parent s compliance; 14) The incidence of DDH is greater (2.7%) in the neonates with idiopathic clubfeet [20],regular hip sonography is recommended at four intervals including the first week after birth, 6 weeks, 3 months and 6 months. Results The demographic characteristic of included cases was presented in Table 1. A total of 90 patients, 69 boys and 21 girls, with 136 clubfeet met the inclusion and exclusion criteria. The patients were followed up at the mean interval of 4.3 years ranging from 3 to 8 years. There were 45 patients with bilateral clubfeet and 46 with unilateral clubfoot (30 right clubfeet and 16 left clubfeet). The number of clubfeet and clubfoot sides in male and female patients was presented in Figure 1 with the ratio of male and female 3.3:1. The mean age at presentation was 39.2 days ranging from 2 to 180 days after birth. The mean Pirani score was 3.2 points ranging from 2 to 6 points and the mean Dimeglio score was 13.6 points ranging from 6 to 19 points. The complete correction was obtained initially in all the cases (100%), requiring mean numbers of 3.8 ranging from 2 to 7 casts. The procedure of PAT was required in 124 clubfeet (91.2%). One of clubfoot case with presentation age of 7 days was referal to our clinic in Dec (Figure 2). He was idenfitified with bilateral equinus, adductus, varus, and cavus, and treated with a series of mainupulation and casting. After completion of the whole protocol of Ponseti treatment, good outcome was achieved after 8 years follow-up (Figure 3). Table 1: Patients demographics. Information Initial treatment No. of infants (cases) No. of feet Side Bilateral (cases) 45 8 Right (cases) 30 3 Left (cases) 16 2 Presentation age 39.2 (2~180) days Pirani score 3.2 (2~6) - Relapse 37.5 (11~60) months Dimeglio score 13.6 (6~19) 9.5 (6~13) No.of casts (before PAT) 3.8 (2~7) 3.9 (2~9) PATcases/feet 83/ Feb Relapse pattern Equinus and adductus(cases/feet) 06-Oct Adductus (cases/feet) 05-Aug Reason of relapse 2 This article is available from:

Noncompliance (cases/feet) 06-Sep Unclear or valid brace- wearing (cases/ feet) 06-Nov ICFSG score 6.71 (4~9) 6.

Figure 2: A-7-day boy with bilateral clubfoot presented in our clinics with the total pirani score of 6 points. a. anterior position of the foot, b. posterior position of the foot.

foot supination during the swing phase of gait.

3 Noncompliance (cases/feet) 06-Sep Unclear or valid brace- wearing (cases/ feet) 06-Nov ICFSG score 6.71 (4~9) 6.83 (4-10) Figure 1: The number of clubfeet and clubfoot sides in male and female patients. Figure 2: A-7-day boy with bilateral clubfoot presented in our clinics with the total pirani score of 6 points. a. anterior position of the foot, b. posterior position of the foot. with 9 clubfeet was attributed to the noncompliance of FAO brace wearing, 6 patients (11 feet) had no identified reason or valid brace-wearing and 1 case required the procedure of TATT because of the foot supination during the swing phase of gait. Relapse was presented in 10 feet as equinus and adductus, which was followed by the deformity of adductus in 8 feet, then the deformity of equinus in 2 feet. The treatment of relapsed deformity required the mean numbers of 3.9 ranging from 2 to 9 casts while repeated PAT procedure was required in 2 feet (1 patient). All the relapsed cases were evaluated good or excellent results according to the International Clubfoot Study Group (ICFSG) score system after the treatment of repeated Ponseti method or the procedure of TATT. One of relapsed cases, who was treated using series of manipulation and casting in other clinical centers, was referal to our clinic in Dec (Figure 4). Her relpased age was 6 years old after her brace-wearing phase of 2 years. She was treated with 6 times of manipulation, casting and additional one year brace-wearing without the procedure of PAT and TATT. No component of equinus, adductus, varus, and cavus, was found after 2 years of follow-up (Figure 5). The result of gait analysis showed that right foot was severely restricted in plantar flexion during one complete gait cycle before treatment. The plantar flexion of ankle improved greatly after the repeated Ponseti management in the stance phase, but the residual plantar flexion of the ankle still existed at the end of swing phase (Figure 6). No walking barrier was observed for the patient. Figure 3: Eight years follow-up for the same patient. a. no adductus, b. no varus, c and d. no curve of lateral border, E and F. no equisus. Relapse was defined as recurrence of any component of the deformities including adductus, varus, cavus and equinus, which required further intervention including either repeated procedure of manipulation and casting or surgical intervention. The relapse of clubfoot deformity was identified in 21 of 136 (15.4%) feet at the mean age of 37.5 ranging from 11 to 60 months. We determined the severity of the clubfoot deformity using the scale of Dimeglio assessment, rating the feet from 0 (normal) to 20 (rigid) points. The average score of Dimeglio was 9.5 for 21 relapsed clubfeet with a minimum score of 6 and a maximum score of 13. Of thirteen relapsed cases, 6 patients Figure 4: Right clubfoot girl relapsed at 6-year old with the Dimeglio score of 10. A. adductus, B. slight equinus, C. later border curve, D. varus, E. More pressure of lateral midfoot. Under License of Creative Commons Attribution 3.0 License 3

Figure 5: The relapsed clubfoot was treated using repeated Ponseti method. a. no varus,b. good appearance of foot, c, no varus but smaller circumference of leg, d.

Discussion Over the past ten years, great changes have taken place due to the nation-wide awareness campaign led by our center regarding the Ponseti management for clubfoot in China [21].

4 Figure 5: The relapsed clubfoot was treated using repeated Ponseti method. a. no varus,b. good appearance of foot, c, no varus but smaller circumference of leg, d. X ray photo of anterior and posterior position of the foot, e. X ray photo of lateral position of the foot. Discussion Over the past ten years, great changes have taken place due to the nation-wide awareness campaign led by our center regarding the Ponseti management for clubfoot in China [21]. However, the mission for distributing the Ponseti method is facing a lot of difficulties, especially in rural and healthcare underserved regions or towns. Quite a number of orthopaedic surgeons still prefer the surgical regime when the patients get into the walking age. In our practice, it was not uncommon to see the cases, which received some types of conservative treatment protocols before their referral to our center, such as massage, splint, modified shoes, casting, and even some ones which were claimed Ponseti method. Because the clubfoot incidence varies with the regions and races [6,7,22], it is supposed to be of demographic significance to recognize the features of clubfoot management for the awareness campaign of Ponseti method, professional training and patient education in China. Figure 6: The result of gait analysis. Pre-treatment shwed that right foot was severely restricted in plantar flexion. Post-treatment showed that the plantar flexion of ankle improved greatly, but the residual plantar flexion still existed at the end of swing phase. The consensus has been reached in that the initial treatment of clubfoot should be non-operative and the treatment should be started soon after birth [8,23]. However, Iltar et al. [24] reported that casting with the Ponseti method in infants older than 1 month of age or with an affected foot 8 cm in length had a better final Dimeglio score. In the present study, we started Ponseti method treatment as early as 2 days (2 cases) after birth and good foot morphology and function were obtained at the middle-term follow-up. No serious complication was found including cast slippage, rocker-bottom deformity and skin problems for the two cases. As reported in the published studies, up to 73% to 100% of patients underwent a procedure of PAT [14-16,25]. The PAT rate was 91.2% (124/136 feet) in this series for correcting the equinus deformity. The relatively higher PAT rate was supposedly attributed to the fact that PAT was indicated in case of ankle dorsiflexion less than 15 degrees in this study. Based on the data from 90 cases in our series, it was presented that the relapse rate was 15.4% (13 cases/21 feet) and the average relapse age was 37.5 months. Morcuende et al [3] reported that there were 17 (10%) cases relapsed after initial successful treatment and average relapse age was 26 months. Dobbs et al. [2] reported that relapse was detected in sixteen infants (31%; twenty-seven feet) at a mean age of six months (range, three to eighteen months). Regarding the reason for relapse, it was demonstrated that 6 patients (9 feet, 42.9%) were not compliant with the use of foot abduction orthosis. Dobbs et al. [2] reported that twenty-one infants (41%) had not complied with the use of orthosis. For the relapsed cases, patients were treated with repeated Ponseti method. The results presented that 20 feet (95.2%) were corrected with a second series of applying manipulation and 4 This article is available from:

5 casting without PAT procedure and one case (one foot, 5% feet) required the procedure of TATT. All the relapsed cases were evaluated good or excellent results according to the International Clubfoot Study Group (ICFSG) score system after the treatment of repeated Ponseti method or the procedure of TATT. Ponseti et al. [8] reported that 27 feet of 53 relapsed feet required the procedure of TATT. In our practice, three dimensional gait analysis was employed for the evaluation of dynamic supination during the swing phase of gait. Supposedly this precise assessment of dynamic supination may reduce the number of the cases, which were diagnosed as the relapsed case indicated for the procedure of TATT. The most frequent recurrence was represented by the compound deformity of equinus and adductus and followed by the deformity of adductus, which was different from the findings by Professor Ponseti [26]. This is supposedly attributed to the difference in defining the relapse. Here, we defined equinus as dorsiflexion no less than 0 according to International Clubfoot Study Group (ICFSG). It is of clinical significance to select the minimum of 3 years as the critical follow-up interval because: 1) The children are inclined to more walking requirement and more reluctant in brace wearing with an increase in age, especially after 3 years old, therefore the brace noncompliance becomes the predominant problem;2) The phase of brace wearing is close to an end or has been finished, and the parents may not pay enough attention to the brace-wearing. The merit of this study was that the consecutive cases, undergoing the Ponseti management in our center since almost 10 years, were reviewed from initial treatment to the termination of brace-wearing, and evaluated in terms of clinical efficacy and outcome measure according to International Clubfoot Study Group (ICFSG). However, this study is limited by the number of included subjects and the relatively shorter follow-up period. In addition, we did not apply neither an ankle foot function scale (e.x. AOFAS Ankle Hindfood Scale, SF-36, and so on), nor the data of three dimensional gait analysis to evaluate the walking function of ankle and foot after PAT procedure. In conclusion, it is demonstrated that Ponseti method is of critical efficacy in treating idiopathic clubfoot during the neonatal period and good clinical outcome can be obtained by reapplying the Ponseti method for the relapsed cases. References 1. Zhao D, Li H, Zhao L, Liu J, Wu Z, et al. (2014) Results of clubfoot management using the Ponseti method: do the details matter? A systematic review. Clin Orthop Relat Res 472: Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, et al. (2004) Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am 86: Morcuende JA, Dolan LA, Dietz FR, Ponseti IV (2004) Radical reduction in the rate of extensive corrective surgery for clubfoot using the Ponseti method. Pediatrics 113: Miedzybrodzka Z (2003) Congenital talipes equinovarus (clubfoot): a disorder of the foot but not the hand. J Anat 202: Dietz F (2002) The genetics of idiopathic clubfoot. Clin Orthop Relat Res 401: Liu Y, Zhao D, Zhao L, Li H, Yang X (2016) Congenital Clubfoot: Early Recognition and Conservative Management for Preventing Late Disabilities. Indian J Pediatr 83: Yi L, Zhou GX, Dai L, Li KS, Zhu J, et al. (2013) An descriptive epidemiological study on congenital clubfoot in China during 2001 to Sichuan Da Xue Xue Bao Yi Xue Ban 44: Ponseti IV, Smoley EN (2009) The classic: congenital club foot: the results of treatment Clin Orthop Relat Res 467: Laaveg SJ, Ponseti IV (1980) Long-term results of treatment of congenital club foot. J Bone Joint Surg Am 62: Cooper DM, Dietz FR (1995) Treatment of idiopathic clubfoot. A thirty-year follow-up note. J Bone Joint Surg Am 77: Herzenberg JE, Radler C, Bor N (2002) Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop 22: Colburn M, Williams M (2003) Evaluation of the treatment of idiopathic clubfoot by using the Ponseti method. J Foot Ankle Surg 42: Panjavi B, Sharafatvaziri A, Zargarbashi RH, Mehrpour S (2012) Use of the Ponseti method in the Iranian population. J Pediatr Orthop 32: e Richards BS, Faulks S, Rathjen KE, Karol LA, Johnston CE, et al. (2008) A comparison of two nonoperative methods of idiopathic clubfoot correction: the Ponseti method and the French functional (physiotherapy) method. J Bone Joint Surg Am 90: Abdelgawad AA, Lehman WB, Van Bosse HJP, Scher DM, Sala DA (2007) Treatment of idiopathic clubfoot using the Ponseti method: minimum 2-year follow-up. J Pediatr Orthop B 16: Haft GF, Walker CG, Crawford HA (2007) Early clubfoot rcurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am 89: Adegbehingbe OO, Adetiloye AJ, Adewole L, Ajodo DU, Bello N, et al. (2017) Ponseti method treatment of neglected idiopathic clubfoot: Preliminary results of a multi-center study in Nigeria. World J Orthop 8: Smythe T, Chandramohan D, Bruce J, Kuper H, Lavy C, et al. (2016) Results of clubfoot treatment after manipulation and casting using the Ponseti method: experience in Harare, Zimbabwe. Trop Med Int Health 21: Saetersdal C, Fevang JM, Bjorlykke JA, Engesaeter LB (2016) Ponseti method compared to previous treatment of clubfoot in Norway. A multicenter study of 205 children followed for 8-11 years. J Child Orthop 10: Zhao D, Rao W, Zhao L, Liu J, Chen Y, et al. (2013) Is it worthwhile to screen the hip in infants born with clubfeet? Int Orthop 37: id=8784. Accessed 22 March Liu YB, Jiang SY, Zhao L, Yu Y, Zhao DH (2017) Can Repeated Ponseti Management for Relapsed Clubfeet Produce the Outcome Comparable With the Case Without Relapse? A Clinical Study in Term of Gait Analysis. J Pediatr Orthop. 23. Ikeda K (1992) Conservative treatment of idiopathic clubfoot. J Pediatr Orthop 12: Under License of Creative Commons Attribution 3.0 License 5

6 24. Iltar S, Uysal M, Alemdaroglu KB, Aydogan NH, Kara T, et al. (2010) Treatment of clubfoot with the Ponseti method: should we begin casting in the newborn period or later? J Foot Ankle Surg 49: Hemo Y, Segev E, Yavor A, Ovadia D, Wientroub S, et al. (2011) The influence of brace type on the success rate of the Ponseti treatment protocol for idiopathic clubfoot. J Child Orthop 5: Ponseti IV (2002) Relapsing clubfoot: causes, prevention, and treatment. Iowa Orthop J 22: This article is available from:

Financial Disclosure. The authors have not received any financial support for the preparation of this work.

Financial Disclosure. The authors have not received any financial support for the preparation of this work. Persistent Clubfoot Deformity Following Treatment by the Ponseti Method W.B. Lehman, M.D. Alice Chu, M.D. New York Ponseti Clubfoot Center Department of Pediatric Orthopaedic Surgery Financial Disclosure