What Is the Best Treatment for Idiopathic Clubfoot?

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Chapter 36 What Is the Best Treatment for Idiopathic Clubfoot?

FREDERICK R. DIETZ, MD

The best treatment for idiopathic clubfoot is the simplest, safest, least expensive, and most rapid method to correct the clubfoot deformity, maintain correction, and allow lifelong normal foot function. Clearly, several potential questions need to be addressed. For example, the treatment that most rapidly corrects deformity may result in painful feet long term. The safest technique for initial correction may be less effective than other techniques. Clarifying the questions to be answered is critical to evaluating the quality of evidence available.

This chapter addresses the following questions: (1) What treatment best obtains initial correction in idiopathic clubfoot? (2) What treatment best maintains correction? (3) What treatment gives the best long-term foot function? Treatment techniques for severe recurrent deformities from failed treatment such a triple arthrodesis and Ilizarov approaches are not addressed.

Few investigations of “high-level” evidence address these questions. There are several reasons for this. First, true randomized studies of very different treatment methods have not been performed and will not be performed for ethical reasons. No orthopedic surgeons are agnostic with respect to the best treatment for clubfoot. Minor variations within a treatment approach are much more likely to be randomized. Second, the severity of clubfeet appears to vary in ways that are difficult to quantitate. This inability to classify feet results in stratification of individuals within a cohort of clubfoot patients who are treated in different ways based on nonquantifiable distinctions of their treating physicians, resulting in selection bias for a particular treatment. One practitioner’s “mild” deformity may be another practitioner’s “moderate” deformity. If these practitioners choose treatment with manipulation or posteromedial release (PMR) based on the “severity” of deformity, the results of their treatment regimens will not be comparable. Rating scales of severity at birth have not been shown to identify difficulty with initial correction, maintenance of correction, or long-term function for different treatment techniques. That a particular scale can predict success with a particular treatment technique has been shown, but this result cannot be generalized a priori to other techniques.1 When a technique, such as the Ponseti method, results in near-universal early correction, there is no value of rating scales for predicting the likelihood of initial deformity correction. A useful rating scale would need to predict recurrence risk or long-term outcome. No such rating scale exists. Therefore, we do not have a common starting point for comparing treatment techniques that is validated, and there may never be one. This is particularly important because many case series are a mixture of techniques based on the treating physician’s view of the severity of the deformity. Thus, many case series describe a treatment given to a selected group of patients with clubfoot from a cohort that is not defined. Third, recurrence of deformity, as opposed to failure of complete correction, is ill-defined. Generally, recurrence is in the eye of the beholding physician. Proxy measures, such as repeat surgery or need for further casting, are crude measures of recurrence. Fourth, outcome studies of sufficient length and quality to answer the question “What treatment method gives the best lifelong foot function?” are rare. A true comparative study of different methods that met Level I or II standards would require funding and commitment at a level that such studies have not and may never be performed. One confounding factor that occurs commonly in all surgical fields is that the surgical procedure is constantly “tweaked” so that long-term studies are rarely strictly comparable with the present “best” surgical treatment.

Despite these problems, data do exist that suggest best treatments. Case series studies of similar patients treated by different treatments because of a change in practice of a single or group of practitioners can be compared. Outcome studies utilizing validated outcome instruments of case series are beginning to be performed, and such studies can be compared. Multiple case series of a specific technique can be compared with multiple case series using a different technique.

The data used to attempt to answer the questions come from an Embase and Medline search for Level I and II evidence studies written in the English language from 1950 to 2007. Almost no relevant studies were found. Using the same research strategy from 2000 to 2007, a few Level III evidence studies and several Level II studies, not initially identified, were found. Because of the paucity of information, the same databases were searched for Level IV evidence studies from 2000 to 2007, of which there were 77 identified. These case series studies were supplemented with earlier case series studies that the author believes were most informative. The analysis does not meet the standard of a systematic review. The quantity of case series studies before 2000 and in non–English language publications that would need to be surveyed for a systematic review was beyond the scope of this project but may be a worthwhile undertaking. I will attempt to give an accurate appraisal of the quality of evidence, but it should be noted that the quality of evidence is not what would be desired or expected for such a relatively common disorder.

WHAT TREATMENT BEST OBTAINS INITIAL CORRECTION IN IDIOPATHIC CLUBFOOT?

The question of what treatment best obtains initial correction in idiopathic clubfoot asks what nonoperative (or largely nonoperative technique if percutaneous tendo Achilles lengthening [TAL] is included) treatment is most effective is correcting clubfoot deformities. Neonatal surgical correction by major ligament release has not succeeded in giving lasting correction and has been abandoned. Many idiosyncratic techniques for manipulating and immobilizing clubfeet exist. In much of the literature, the question is not addressed because the studies are of surgical treatments. The authors simply state that feet uncorrected conservatively had their surgical treatment. When stated, the number of feet that were conservatively corrected varies from 5% to 60% in most studies, but specific treatment techniques are rarely specified. The most prominent published techniques are those of Kite and Denis Browne from the 1930s, Ponseti from the 1960s, and Dimeglio and Bensahel from the 1990s. The Kite method was by far the most common technique used in the United States until the recent popularity of the Ponseti method.

Sud and colleagues2 compared rates of initial correction and relapse comparing the Ponseti and Kite methods in a prospective, randomized study with outcome assessment by a surgeon who was blinded to the treatment. The clinic in which the children were treated had used the Kite method for 15 years and the Ponseti method for 1 year before beginning the study. Fifty-three patients with 81 feet were enrolled, and 8 were lost to follow-up and excluded from analysis. Thirty-six feet treated by the Ponseti method and 31 feet treated by the Kite method were followed for an average of 26 months. The Ponseti method had a 91.7% initial correction rate compared with 66.7% by the Kite technique. Ponseti method feet had a 21.1% relapse rate over the course of the study compared with a 38.1% relapse rate for the Kite method. The mean number of casts was statistically significantly less for the Ponseti method (6.2, Ponseti method; 10.7, Kite method), and the mean time to correction was significantly shorter for the Ponseti method (49.2 days, Ponseti method; 91.2 days, Kite method).

Three other studies address the question of early correction by comparing different methods. Herzenberg, Radler, and Bor3 in Maryland and Israel compared their first 27 patients treated by the Ponseti method with 27 patients matched from their database who had been treated by a variety of manipulative techniques by the authors or referring physicians. Their major outcome variable was need for PMR in the first year of life because of failure to correct the deformity. Only 1 foot required PMR (97%) correction with the Ponseti technique compared with only 2 feet corrected without PMR in the historical control group, which had a 6% success rate. Segev and coworkers4 compared 61 clubfeet treated by a modification of the Kite and Lovell method and managed an average of 55 months with their initial 48 feet treated with the Ponseti method that were managed for an average of 29 months with a 16-month minimum. The feet treated by the Kite and Lovell method required surgical correction in 56% of the feet. Of the feet treated by the Ponseti method, 3 (6%) required surgical correction.

Aurell and researchers5 in Sweden report a center randomized study of clubfeet treated by 2 different techniques. A consecutive series of children with clubfoot was treated by the Ponseti method at 1 hospital (9 feet) and by the Copenhagen method at another hospital (19 feet). The Copenhagen method involves manipulation by a physiotherapist 4 to 5 times per week with correction maintained by a plexidur splint for 1 month, followed by 1 or 2 times per week manipulation in the second week. At 2 months of age, a pediatric orthopedic surgeon decided whether further treatment was needed. All 9 feet treated by the Ponseti technique required only a percutaneous TAL. Of the 19 feet treated by the Copenhagen method, 12 required PMR (63%) and 1 required a posterior release (5%).

Many case series studies address the effectiveness of the Ponseti method for early correction. Changulani and researchers6 report their initial experience in the United Kingdom using the Ponseti method in 100 feet in 66 children. Ninety-six of 100 feet were fully corrected with 85 requiring percutaneous tenotomy. Colburn and Williams7 report complete initial correction of 54 of 57 feet (95%) of the first babies they treated by Ponseti method in San Francisco. Goksan and coauthors8 report on 134 feet with 97% follow-up to mean age of 46 months with a minimum of 2 years after initial casting in Turkey. Only 4 patients required PMR. Lehman and colleagues9 in New York reported successful correction in 92% of the first 45 feet treated by the Ponseti method. Tindall and coworkers10 report initial correction of 98 of 100 in Malawi by nonphysician orthopedic paraprofessionals. Shack and Eastwood11 report initial correction of 39 of 40 children in a physiotherapist-delivered Ponseti program in the United Kingdom. Morcuende and colleagues12 report initial correction in 98% of 256 feet treated by Dr. Ponseti and others at the University of Iowa.

A number of case series reports have been published of the French or Montpellier method of physiotherapy correction of clubfoot. Physiotherapy was developed and refined by Masse, Bensehal, Dimeglio, Metaizeau, and others. The technique has been published in English, but several case series in French are not included here. Dimeglio reported on three groups of feet during the evolution of the treatment in 1996. The best group consisted of 52 clubfeet. Forty percent were corrected without surgery; 35% required PMR or PMRL; and 25% required posterior release. Van Campenhout and investigators13 evaluated their results of physiotherapy and continuous passive motion machine in 64 babies with 100 feet. The authors included only infants presenting at younger than 3 months whose family strictly adhered to the protocol. With a minimum follow-up of 18 months and a mean follow-up of 3.2 years, 75 (75%) of the feet required surgery. Richards and coauthors14 report on 142 feet in 98 babies treated by the French method.14 With an average follow-up of 35 months, 20% required PMR and 29% required posterior release. Souchet and colleagues15 report what appears to be a largely personal series of Bensahel of 350 clubfeet followed to skeletal maturity. Twenty-three percent required surgical treatment at a mean age of 1 year. Stromqvist and coworkers16 report on 75 feet treated by a strict physiotherapy and bracing regimen, and managed for an average of 8 years. Sixty-seven (89%) of the feet underwent posterior release (PR) (two thirds) or PMR (one third) between 2 and 5 months of age.16 Twenty-five feet (33%) required a second operation at a mean of 4 years, and 4 feet had a third operation.

Summary

Reasonably strong evidence exists that the Ponseti method is the best treatment to obtain initial correction in idiopathic clubfoot. Although high-level evidence studies are few, they are entirely consistent in supporting the Ponseti method as the most effective and rapid technique. Case series are persuasive because all show a more than 90% initial correction rate, which is greater than that reported in any report for other methods. Furthermore, most series report the authors’ early experience, and results would be expected to improve with experience. That the results have been replicated in many parts of the world by medical practitioners of varying levels of training, all support the conclusion that the Ponseti method is the “best” method for initial correction of idiopathic clubfoot.

WHAT TREATMENT BEST MAINTAINS CORRECTION?

Relapse of deformity that requires treatment in clubfoot is in the “eye of the beholder.” No technical cutoff exists to say when a correction is inadequate versus when a recurrence of deformity has developed. Therefore, relapse rates are likely to vary between different investigators. Nonoperatively treated clubfeet that lose correction will relapse into a clubfoot deformity with varying amounts of recurrent equinus, varus, adductus, and cavus. Operatively treated feet may relapse in a similar way but may also lose correction into foot positions such as severe planovalgus, severe cavus from dorsal dislocation of the navicular, dorsal bunion development, and any combination of relapse and overcorrection of the initial deformities. In general, recurrent deformity requiring further treatment is reported to compromise results. One long-term report of the Ponseti method suggests that relapse of a certain type, at a certain age, can be managed in a way (anterior tibial tendon transfer to the third cuneiform) that does not compromise long-term foot function.17 Nonetheless, most relapses in corrected clubfoot treated nonoperatively occur in the first 5 years of life. The surgical literature, which is largely short- to medium-term follow-up studies (2–8 years), also suggests that recurrent deformity or overcorrection tends to occur during the rapid growing period of the foot.

For the purposes of this section, I define “need for further surgery after initial correction” as a surrogate for relapse in reports of surgically treated feet. Investigations of feet treated surgically in infancy almost never report using manipulation and casting to treat recurrent deformity. Therefore, only further surgery indicates a change in foot morphology that the investigator thought required treatment. Adherents of the Ponseti method will treat relapse at an early stage with repeat casting, and at a later age with an anterior tibial transfer under most circumstances. This is not considered a failure based on current long-term follow-up data and, therefore, is discussed somewhat differently than a recurrence requiring further surgery. Note that some feet may require further treatment because of symptoms, without incurring new deformity. Therefore, need for further surgery is not a distinct end point but is the best available surrogate.

The literature I use to address this question is largely case series studies with follow-up periods shorter than skeletal maturity for most patients. Most of these studies purport to be “outcome” studies. Most of these studies use unvalidated, idiosyncratic rating scales that mix symptoms, physical finding, and radiographic findings in arbitrary ways to develop “excellent/good/fair/and poor” ratings. The only value of these studies is for assessing early complication rates such as relapse. These are not considered in the last section on long-term outcome. Bad results can be identified at any age, but I will not consider a study to address long-term foot function until the cohort studied is at least mostly skeletally mature. Another weakness of many of these studies is that comparisons of different treatment methods were done based on a change in practice so that the follow-up lengths are markedly different between the treatment groups. Finally, the reporting of basic data such as age at operation, length of follow-up, rate of follow-up, and rate of reoperation are often absent or unclear in the published manuscripts. Some interpretation is occasionally necessary, which certainly reduces accurate assessment of the data reported.

A number of Level III evidence studies comparing different surgical treatment techniques demonstrate the problem of markedly different follow-up periods between different techniques that were utilized at various times at single institutions.

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