Abstract

　　Background Although the Ponseti method is accepted as the bestchoice for treatment of clubfoot, the treatment protocol is labor intensive andrequires strict attention to details. Deviations in strict use of this methodare likely responsible for the variations among centers in reported successrates.

　　Questions/purposes We wished to determine (1) to what degree thePonseti method was followed in terms of manipulation, casting, and percutaneousAchilles tenotomy,(2) whether there was variation in the bracing type andprotocol used for relapse prevention, and (3) if the same criteria were used todiagnose and manage clubfoot relapse.

　　Methods We conducted a systematic review of MEDLINE,EMBASETM, andthe Cochrane Library. Studies were summarized according to the PreferredReporting Items for Systematic Reviews and Meta-analyses Statement.Five hundredninety-one records were identified with 409 remaining after deduplication, inwhich 278 irrelevant studies and 22 review articles were excluded. Of theremaining 109 papers, 19 met our inclusion criteria. All 19 articles weretherapeutic studies of the Ponseti method.

　　Results The details of manipulation, casting, or percutaneousAchilles tenotomy of the Ponseti method were poorly described in 11 studies,whereas the main principles were not followed in three studies. In threestudies, the brace type deviated significantly from that recommended, whereasin another three studies the bracing protocol in terms of hours of recommendeduse was not followed. Furthermore no unified criteriawere used for judgment ofcompliance with brace use.The indication for recognition and management ofrelapse varied among studies and was different from the original description ofthe Ponseti method.

　　Conclusions We found that the observed clinically important variationmay have been the result of deviations from the details regarding manipulation,casting, percutaneous Achilles tenotomy, use of the bar-connected brace,andindication for relapse recognition and management recommended for the classicPonseti approach to clubfoot management. We strongly recommend that cliniciansfollow the Ponseti method as it initially was described without deviation tooptimize treatment outcomes.

　　Introduction

　　Congenital talipes equinovarus, or congenital clubfoot, is one ofthe most common congenital skeletal defects.Clubfoot can be isolated or canoccur as part of other disorders such as spina bifida, myelomeningocele, orarthrogryposis. A less-invasive regimen developed by Ponseti has gainedacceptance as the gold standard for clubfoot management ^{[9, 10, 24, 29, 37,39]}. This method has been reported to be efficient and effective for clubfoot treatmentbecause of its long-term success and ability to decrease the need for extensivecorrective surgery ^{[9, 10,24, 29, 54]}. The advantages of the Ponseti method arethe high success rate and prevention and management for relapse ^{[37, 48]}. Whenusing this method, attention must be paid to the details of manipulation,casting, bracing, and the treatment of relapses. ^{[9, 10, 24, 29, 37, 48]}.

　　Numerous authors have reported a high initial correction rate andexcellent long-term results using this method ^{[1, 9,10, 24, 29, 33, 39, 40, 43,47]}. However, good results were not replicated by some authors who reportedhigher relapse or surgical rates ^{[7, 17, 26, 35, 36]}. Although the Ponsetimethod is simple, careful attention must be paid to the details in this method.Failure to adhere to details, such as manipulation, type of brace, bracingprotocol, and relapse management, might affect whether one obtains a goodoutcome.

　　The purposes of our study were to determine (1) what degree thePonseti method was followed in terms of manipulation, casting, and percutaneousAchilles tenotomy,(2) whether there was variation in the bracing type andprotocol used for relapse prevention, and (3) if the same criteria were used todiagnose and manage clubfoot relapse.

　　Search Strategy and Criteria

　　A manual systematic literature search of MEDLINE,EMBASETM, and TheCochrane Library without any limit for concepts ‘‘clubfoot’’ OR ‘‘congenitaltalipes equinovarus’’OR ‘‘CTEV’’ AND Ponseti was performed by two of theauthors (DZ and HL). The language was restricted to English. The search wasperformed independently with any disagreements in eligibility resolved byconsensus discussion among all the authors. Study selection was performed in astepwise manner, first by title, then abstract, and then full-text review. Theinclusion criteria were: (1) clinical diagnosis of idiopathic clubfoot; (2) notreatment before presentation at the authors’ institution; and (3) an averagefollowup of more than 2 years. The exclusion criteria were:(1) clubfoot withany known etiology such as spina bifida,myelomeningocele, and arthrogryposis;(2) any history of treatment before presentation at the authors’institutions;and (3) mean followup less than 2 years. The last search wascompleted on July 22, 2013, and the search results on the day of submissionwere not changed.

　　Five hundred ninety-onerecords were identified with 409 remaining after automated deduplication wasperformed.Three individuals (DZ, HL, LZ) reviewed all these articlesindependently. First, we excluded 300 citations including 278 irrelevantstudies and 22 review articles.Of the remaining 109 articles, 80 were excludedbecause they　　did not meet the inclusion criteria, metthe exclusion criteria,or were conference abstracts. Seventeen of the remaining29 studies met our inclusion criteria. Fourteen of these 17 studies ^{[2, 17–21,23, 26, 34, 43, 44, 46, 50, 52]}had usable data and were included; the threeother studies^{[30, 31, 49]} did not have usable data and were excluded.Theremaining 12 studies did not indicate whether all the patients underwent anytreatment before being enrolled in the studies, therefore we sent requests forsupplemental data from the authors of the studies. Responses were received fromthe authors of five studies ^{[1, 7, 35, 36, 45]}that met the inclusion criteria.Nineteen articles ultimately met our inclusion criteria ^{[1, 2, 7, 17–21, 23,26, 34–36,43–46, 50, 52]} (Table 1). These studies were summarized according tothe PRISMA statement ^[27]. A flow diagram of the search process is shown (Fig.1). Most identified studies were considered to be of very low-grade qualityaccording to GRADE criteria [3] owing to their observational nature. There werefive case-control studies ^{[2, 7, 19,21, 43]}, 12 case series studies ^{[1, 17, 18,20, 23, 26, 34–36,44, 45, 52]}, and only two lesser-quality randomizedcontrolled trials ^{[46, 50]} in the 19 studies. The mean age of the patients atpresentation ranged from 2 days to 8.9 years.The classification system ofDime´glio et al. ^[11] or the Pirani system as reported by Dyer and Davis ^[12]were used most frequently for initial assessment of clubfoot deformity ^{[1, 2,7, 17, 18, 20, 23, 34, 35, 43–46, 50, 52]}.Four to 12 casts were required to getfull correction. A percutaneous Achilles tenotomy was performed in 73% ofcases. The initial correction rate was 89.2 %. The rates of noncompliance,relapse, and surgical intervention in these studies varied from 7% to 61%, 3%to 62%, and 3% to 39.4%, respectively (Table 1).

　　Results　The details of manipulation, casting, or percutaneous Achillestenotomy were poorly described in 11 of the 19 studies ^{[7, 17, 18, 20, 21, 23,26, 35, 44, 50, 52]} in which the Ponseti method was used. The core principlesand details were not followed in three studies ^{[20, 36, 50]}, such as conductingopen heel cord Z-lengthening and posterior capsulectomy of the ankle ^[20],pushing the calcaneus into valgus ^[36], and considering no correction in apatient by 1 year old as failure ^[50].The bar-connected brace was prescribed inseven studies as suggested by the Ponseti method ^{[2, 19, 21, 34, 46, 50,52]}. Infour studies, the type and design of brace were partly or completely differentfrom those suggested in the original method ^{[20, 21, 26, 44]}. In 15 studies,the brace protocols were described precisely ^{[1, 2, 17–19, 21, 26, 34–36, 43, 45,46, 50, 52]}, however, in three of these studies,the protocols were presenteddifferently from the others ^{[18, 26, 46]}. The criterion was described in onlyeight studies for the judgment of bracing compliance ^{[1, 2, 18,26, 34, 36, 43,44]}, and the criterion in each study was different (Table 1).

　The definition of relapse was introduced, but varied in eightstudies ^{[2, 7, 17, 34, 35, 43, 46, 50]} (Table 1). The same indications wereused for treatment of relapsed clubfoot in 10 studies ^{[1, 2, 7, 19–21, 34, 46,50, 52]},whereas different indications were used in seven studies in which thepatients did not have additional manipulations and casts used ^{[17, 23, 26, 35,36, 43, 45]}. No statement was made regarding treatment of relapsed clubfoot intwo studies ^{[18, 44]}. In addition, the intraarticular surgical rate differedenormously ^{[1, 17, 19, 21, 23, 26, 34–36, 43–45,50, 52]} (Table 1).

　　Discussion　Conservative treatment generally is accepted as the first choice forcorrection of congenital clubfoot, and the most popular approach is the Ponsetimethod which consists of serial manipulation, casting, and a percutaneousAchilles tenotomy ^{[9, 10, 24, 29, 37, 39, 48]}. The Ponseti method also providesinstruction for treating relapse ^{[9, 10, 24, 29,37, 39, 48]}. We presumed thatno adherence to the details in manipulation, brace type, bracing protocol, andtreatment of relapse might produce different clinical outcomes,and therefore weperformed a systematic review to investigate whether different studies followedthe core principles and details of the Ponseti method. Although there have beentwo systematic reviews of the Ponseti method and clubfoot treatment ^{[15, 22]},our review focuses on adherence of principles and technical details. We foundthat some details of the Ponseti method were either poorly described or notfollowed. Furthermore, some studies used different criteria for relapserecognition and management.

　　Our study has several limitations. First, not all of the 19identified studies in the review provided all the treatment details ofmanipulation, casting, brace protocol, and relapse management, so we couldjudge only the available data. Second, treatment with the Ponseti method mayvary among patients depending on age. We aimed to analyze whether the differentstudies applied similar core principles and details of this method.

　　We found the details ofmanipulation, casting, or percutaneous Achilles tenotomy were poorly describedin 11 studies ^{[7, 17, 18, 20, 21, 23, 26, 35, 44, 50, 52]}, and three studiesdid not adhere to the basic principles of the Ponseti method ^{[20, 36, 50]}. Someauthors reported high initial correction rates using this method ^{[17–19, 21,26,34]}. Ponseti and Smoley reported the results of treatment for 67 patients(94 clubfeet), in which the abnormal relationship between the talus andcalcaneus had not been completely corrected in only five cases after initialtreatment ^[39]. Subsequent studies had 92% to 100% initial correction rates inpatients who were younger than 2 years ^{[1, 2, 6, 8, 19, 24, 25, 29, 34]}.Patients between 1 and 3 years old who were treated with the Ponseti method hadan initial success rate of nearly 90% according to Verma et al.^[52]. Forpatients with a nonidiopathic clubfoot, the Ponseti method is also effective^[16]. The initial correction rates were greater than 94% when clubfeetassociated with myelomeningocele or arthrogryposis were treated with the Ponsetimethod ^{[4, 14, 28]}. Clubfeet in patients undergoing previous posteromedialrelease also were responsive to treatment using the Ponseti method ^{[13, 32]}. Aswe understand, strict adherence to the principles and technical details ishighly related to the outcome of treatment using the Ponseti method. Althoughthe 19 studies showed similar high initial correction rates (Table 1), detailsof manipulation, cast molding, or percutaneous Achilles tenotomy were notdescribed or were poorly described in 11 of these studies ^{[7, 17, 18, 20, 21,23, 26, 35, 44, 50, 52]}.In addition, open heel-cord Z-lengthening and posteriorcapsulectomy of the ankle ^[20], the calcaneus being touched and pushed intovalgus ^[36], and no correction in a patient by 1 year of age were taken as indicationsfor failure ^[50]. Moreover, applying a cast with the patient under anesthesiaor sedation ^{[34, 52]} may lead to skin irritation and ulceration because thepatient cannot react when excessive manipulation is exerted. We do not know ifdoing stretching exercises before weekly casting ^[18] could improve theoutcomes. In older patients, wearing a postoperative cast for 4 weeks ^[23]might contribute to Achilles tendon healing, however, these are not included inthe basic principles of the Ponseti method.

　　Variation also was found for bracing compliance and adherence.During the maintenance period, a bar-connected brace or foot abduction orthosisis used to avoid relapse ^{[29, 37, 48]}. The initial data reported by Ponseti andSmoley showed that the relapse rate was 56% when the brace was worn forapproximately 2 years ^[39]. When the foot abduction orthosis was prescribed tomaintain the completely corrected foot at 60°to 70°external rotation on the affected side and 30° to 40°on the normal side, and the braceprotocol was changed to full-time for the first 3 months and then 12 hours atnight and 2 to 4 hours in daytime until the patient was 3 to 4 years old, therecurrence rate showed a radical reduction ^[29]. In our review,thebar-connected brace which had the same rationale and design as suggested withthe Ponseti method, was prescribed in seven studies ^{[2, 19, 21, 34, 46, 50,52]}. In four studies, an ankle-foot orthosis that could not maintain the footin the position with enough external rotation and dorsiflexionwas prescribed ^{[20, 21, 26, 44]}. The relapse rate was reported to be as much as62.5% when a unilateral ankle-foot orthosis was used during the maintenancephase for treatment of neglected clubfoot ^[26]. However, in another study inwhich the Ponseti method was used for neglected clubfoot but in which a footabduction orthosis was used, the relapse rate was 24% ^[23], which was similarto that for neonatal patients ^{[2, 44, 50, 52]}. This suggested the footabduction orthosis appears to be important in maintaining the correction whichcould not be achieved　with an ankle-footorthosis ^[21]. Moreover, we found the brace protocols in the other threeidentified studies with higher relapse incidences were similar in that theyadvised only night use until the patient was 2 or 3 years old ^{[35, 36,43]},which indicated recurrence could be associated with an insufficient timewearing the foot abduction orthosis ^{[10, 24, 29, 37–39, 53].}Noncompliance in wearingthe foot aduction orthosis was reported to be the leading cause of relapse ^{[1,2, 5, 6,10, 17, 21, 25, 34, 41, 42, 52]}. The noncompliance rates reported inthree studies were 49%, 41%, and 36%, while the patients who did not adhere tothe bracing protocol were five, 183, and 120 times, respectively, more likelyto have a relapse in comparison to children who wore the brace as prescribed^{[2, 10, 17]}. Other authors suggested that noncompliance was associated with a17 times greater odds of relapse compared with compliance ^[29]. Althoughdefinite brace protocols were prescribed in 15 studies ^{[1, 2,17–19, 21, 26,34–36, 43, 45, 46, 50, 52]}, the majority of studies we identified did notemphasize the definite age of the patients when the foot abduction orthosis wasterminated or the exact hours of night and naptime (some advised night useonly) use after the first 3 months ^{[1, 2,17, 19–21, 35, 36, 43–45, 50, 52]}(Table 1). Ambiguous brace protocols might result in significant deviationswhen parents follow undefined instructions and make it difficult for the pediatricorthopaedic surgeon to ensure whether a patient is compliant with wearing thefoot abduction orthosis. The noncompliance rates for the foot abductionorthosis from the studies we identified in this review were　remarkably different from each other ^{[1, 2, 17, 19, 29, 51,52]}.Beyond the effect of different bracing protocols, the significant variations innoncompliance rates may be attributed to the lack of unanimous criteria tojudge noncompliance ^{[1, 2, 17, 18, 34, 36, 43, 44]} (Table 1).Unfortunately, onlyeight studies had criteria for brace compliance judgment which were totallydifferent from each other ^{[1, 2, 18, 26, 34, 36, 43, 44]} (Table 1). Apart fromthis, inappropriate wear of the brace also could be considered nonadherence,because the brace cannot maintain the correction effectively ^[53]. Compliancewearing a foot abduction orthosis does not mean proper application of thebrace. Only adherence with brace use and wearing it for enough time caneffectively prevent relapse.

　The definition of recurrencevaried among studies,which reported a wide range of relapseoccurrence.Recurrence was defined by Morcuende et al. ^[29] and Ponseti ^[37] asthe reappearance of any of the components of the deformity. Eight studiesidentified in our review defined relapse of clubfoot deformity and all definedrelapse the same as in the original description of the Ponseti method ^{[2, 7,17, 34, 35, 43, 46, 50]}, except for one study in which relapse was defined as afair or poor outcome ^[43]. Relapses should be treated with a second series ofmanipulations and casting with or without percutaneous Achilles tenotomy, andthe tendon of the tibialis anterior muscle should be transferred to the thirdcuneiform in case of dynamic supination of the forefoot during the swing phaseof gait ^{[37, 48]}. If a patient has a second relapse, the same method oftreatment was suggested ^{[37, 48]}. In 10 studies, the same indications were usedfor relapse management as suggested for the Ponseti method ^{[1, 2, 7, 19–21, 34,46, 50, 52]} (Table 1), whereas seven studies did not recommend additionalmanipulation and casting ^{[17, 23,26, 35, 36, 43, 45]} for relapse management.Percutaneous Achilles tenotomy and tibialis anterior tendon transfer areextraarticular procedures which are much less invasive to the foot than releaseof the tarsal joints. These two procedures were thought to be part of thePonseti method ^[37,48]. Five studies identified in our review had highersurgical rates ^{[17, 26, 35, 36, 43]} because of not applying repeatedmanipulation and casting ^{[17, 35, 36]}, prescribing an ankle-foot orthosis forolder children after initial correction ^[26], or not considering tibialisanterior tendon transfer as a part of the Ponseti method in treatingrelapse^[43].

　　Although the Ponseti methodhas been accepted as the primary means for clubfoot management, there aresubstantial deviations in the details from different studies. We presumed thatthe differences in reported clinical outcomes might be attributed to thefailure in following the details of the original descriptions of the Ponsetimethod, especially regarding manipulation, type of brace, brace protocol, andrelapse management. We believe that it is important for clinicians andresearchers either to adhere to the details and principles of this method, orto compare newer approaches that deviate from the original approach. Consensusis needed through scientific research, communications, and training workshops.We believe that the outcome of clubfoot management can be optimized throughthis approach when every core detail of the Ponseti method is followed.

　　Acknowledgments We thankDavid A. Spiegel MD and Monica P.Nogueira MD for their input in the discussionand communications which encouraged us to do this investigation.

选自《Clinical Orthopaedics and Related Research®》

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