Evidence-Based Treatment for Clubfoot

Fig. 16.1

Clinical photographs showing classical deformity of a clubfoot

Clubfoot can be:

Idiopathic clubfoot which presents as an isolated anomaly in a normal child.
Non-idiopathic clubfoot which is associated with other neuromuscular or congenital anomalies
Complex or atypical idiopathic clubfoot which is defined as having rigid equinus, severe plantar flexion of all metatarsals, a deep crease above the heel, a transverse crease in the sole of the foot, and a short and hyperextended first toe.

Idiopathic clubfoot responds well to treatment but non-idiopathic or complex clubfoot may be amenable. Most of the evidence for management of clubfoot is available for the idiopathic type. Treatment options for the non-idiopathic or the complex idiopathic clubfoot are discussed separately in later sections.

What Is the Best Treatment for Idiopathic Clubfoot?

Management of clubfoot can be broadly divided into non operative (Ponseti, Kite, French methods) and operative types. Although several randomised controlled trials (RCT), cohorts’ studies, case series have investigated various aspects of clubfoot treatments; most have limitations which leave some uncertainty about certain aspects of the treatments. In this section we endeavoured to simplify the evidence for each treatment without dismissing the limitations of the best available evidence we currently have.

Over the last 20 years, Ponseti’s serial casting treatment for clubfoot has emerged as a superior treatment to other non operative and operative treatments. This has been supported by evidence from a systematic review and meta-analysis [3]; RCTs [4–6] and long term cohorts studies [7–10]. Gray [3] conducted a Cochrane review of clubfoot treatment including 14 trials (607 participants) and concluded that The Ponseti’s Methods produced significantly better short term foot alignment compared to other non operative methods including the Kite methods. Relapse following the Kite’s methods more often led to major surgery compared to relapse following The Ponseti’s Methods.

Sud [5] conducted an RCT comparing The Ponseti Methods and Kite methods. Baseline Dimeglio scores were similar between the two groups. After an average follow-up of 27 months in the Ponseti group, correction was achieved in 33 feet (91.7 %), with only three patients requiring surgical management. There were seven relapses (21.1 %), all of which were corrected conservatively. In the Kite group, correction was achieved in 21 feet (67.7 %) after an average follow-up of 25 months, with 10 patients requiring surgical intervention. There were eight relapses of which only four could be corrected conservatively.

Sanghvi [4] compared the long-term results of the Kite and Ponseti methods of manipulation and serial casting for clubfoot in 42 patients (with 64 idiopathic clubfeet) who were randomised to either Kite or Ponseti treatments in the early weeks of life. All the clubfeet were manipulated, casted, and followed up (for a mean of 3 years) by one experienced orthopaedic surgeon. The success rate in The Kite Method was 79 % and that in the Ponseti’s method was 87 %. With The Ponseti method, the number of casts was significantly fewer (7 vs. 10); the duration of casting required to achieve full correction was significantly shorter (10 vs. 13 weeks); the maximum ankle dorsiflexion achieved was significantly greater (12° vs. 6°); and the incidence of residual deformity and recurrence was slightly lower. The study was not clear if the two groups were comparable at baseline.

Rijal [6] randomly allocated 60 feet in 38 patients to either Ponseti (30 feet) or Kite (30 feet) methods. Feet were followed up weekly for 10 weeks for change of cast and recording of hindfoot, midfoot and total Pirani scores. Correction was measured as a difference between hindfoot, mid foot and total Pirani scores weekly from weeks 1 to 10 and corresponding baseline scores. Mean Pirani scores in Ponseti feet improved much faster than Kite feet but the difference achieved statistical significance only at the 10(th) week from the start of treatment.

Richards [11, 12] compared the results of Ponseti and French methods in 386 feet in 256 children under the age of 3 months at presentation. Treatment allocation was on the basis of parental choice after the pros and cons of both techniques had been explained. Mean follow up was 4.3 years. The two groups had similar grades of severity scores before treatment. The initial correction rates were 94.4 % for the Ponseti method and 95 % for the French functional method. Relapses occurred in 37 % of the feet that had initially been successfully treated with the Ponseti method. One-third of the relapsed feet were salvaged with further non operative treatment, but the remainder required operative intervention. Relapses occurred in 29 % of the feet that had been successfully treated with the French functional method, and all required operative intervention. At the time of the latest follow-up, the outcomes for the feet treated with the Ponseti method were good for 72 %, fair for 12 %, and poor for 16 %. The outcomes for the feet treated with the French functional method were good for 67 %, fair for 17 %, and poor for 16 %.

Faulks and Gottschalk [13, 14] compared gait analysis of patients treated by the Ponseti method and feet treated by the French method. Normal ankle motion was documented more frequently in the Ponseti feet compared with the French methods. More of the children treated with the French method walked with knee hyperextension, a mild equinus gait, and mild foot drop.

Jeans [15, 16] assessed plantar pressures in feet treated with the Ponseti and the French methods at age 5 years. Twenty controls were used for comparison. Data from 164 patients (238 feet; 122 Ponseti and 116 French) showed no significant differences between the two methods, except the French method feet had a significantly less medial movement of the centre of pressure (COP) than the Ponseti feet (P = 0.0379). This shows that there is a mild residual deformity in these feet despite clinically successful outcomes.

Zwick [17] conducted an RCT of Ponseti versus surgical treatment. All babies were less than 2 weeks old on initiation of treatment. Surgical group (16 feet) received initial manipulation and weekly casting until 6–8 months of age followed by posteromedial release by the Cincinnati incision. Ponseti group (12 feet) received standard Ponseti treatment. Two patients from the Ponseti group crossed over to the surgical group. The authors used the Functional rating system (FRS) devised by Laaveg and Ponseti [18] as the outcome measure. The authors used a priori sample size calculation but were compelled to stop the trial for ethical reasons after interim analysis revealed that the surgical group had worse outcome. Minimum follow up was 3.3 years. The groups had similar baseline Pirani score. At final follow up the FRS score as well as the passive ankle range of motion was better in the Ponseti group. These results are supported by other long term follow up studies. Smith [9] performed a retrospective comparison of surgery (37 feet) with the Ponseti method (29 feet). Both groups were compared with healthy young adults. The authors found that compared to the control subjects both groups had reduced strength and motion of the ankle. However, the Ponseti group had better ankle motion and less pain. Similarly Graf [19] assessed the long term results of surgical release in 24 adults who underwent posteromedial release via the Cincinnati incision before the age of 18 months. The authors found that although surgery resulted in a plantigrade foot; pain, stiffness and weakness gave functional limitations. Dobbs [20] assessed the long term function of 73 feet treated with extensive soft tissue surgery. Mean follow up was 30 years. The authors found that 47 % patients had poor long term foot function as assessed by the Laaveg-Ponseti functional score. This unfavourably compared to Ponseti’s long term follow up results where only 12 % patients had poor results using the same outcome instrument. In addition Dobbs et al found functional limitation to be inversely correlated to the extent of soft tissue surgery.

What Is the Best Treatment for a Late Presenting Clubfoot?

Patients who present after walking age are considered to have presented late. A number of authors from the developing countries have tried Ponseti technique in older children with varying degrees of success. In Lourenco’s [21] series from Brazil, 16 feet were graded as functionally good at a mean follow up of 3.1 years. The mean age was 3.9 years at presentation. Relapses were treated with a repeat TAT but none required tibialis anterior tendon transfer (TATT). The authors suggested longer time for manipulation and less frequent cast changes to allow for remodelling, less abduction in brace and Ankle foot orthosis (AFO) instead of boots and bar brace in the older child (Table 16.1).

Table 16.1

Outcome of treatment for late presenting idiopathic clubfoot

Studies	N (Feet)	Mean age in years	Follow-up in years	Cast required	Relapse	Surgical release
Studies	N (Feet)	Mean age in years	Follow-up in years	Mean (range)	Relapse	Surgical release
Lourenco et al. [21]	24	3.9 (1.2–9)	3.1 (2.1–5.6)	9 (7–12)	7	8
Khan et al. [22]	25	8.9 (7.5–11)	4.7	12 (10–14)	6	?
Yagmurlu et al. [23]	31	2 (1–6)	3.5	6 (4–8)	0	0
Banskota et al. [24]	55	7.4 (5–10)	2.5 (2–3.3)	9.5 (6–11)	9	28
Ayana et al. [25]	32	4.4 (2–10)	3 (2–4)	8 (6–10)	4	6

Khan et al [22] evaluated the efficacy of Ponseti technique in 21 children (25 feet) over 7 years of age. Eighteen feet had a full correction (85.7 %). Dimeglio score improved from 14.2 to 0.18 at final follow up.

Yagmurlu et al [23] published their results of Ponseti treatment in 27 patients (31 feet) who were treated after the walking age. Standard Ponseti technique was used. Seventeen feet required open tenotomy. The authors noticed a significant improvement in all components of the deformity but found that children older than 20 months tended to improve less.

Banskota et al [24] presented a series of 36 patients aged 5–10 on presentation. Mean Pirani score at presentation was 5.1 (3–6). The authors did not modify their standard technique and a higher number of patients in their series underwent surgery. However, 46 feet achieved a plantigrade feet without extensive soft tissue surgery. Twenty-seven children were completely satisfied with the treatment. The authors suggested that the Dimeglio scoring system was more appropriate to assess the feet of older children.

Ayana [25] from Ethiopia prospectively evaluated 22 children aged 2–10 years (32 feet) with neglected clubfoot. All were treated by the Ponseti method. The deformity was assessed using the Pirani scoring system. The average follow-up time was 3 years. A plantigrade functional foot was obtained in all patients. Two patients (four feet) had recurrent deformity. They required re-manipulation and re-tenotomy of the Achilles tendon and one other patient required TATT for dynamic supination deformity of the foot.

Singh [26, 27] presented the results of ligamentotaxis using Joshi’s External Stabilisation system (JESS) in 20 patients. This is a technique of controlled differential distraction using a mini external fixation. The case series included late presenters as well as relapses and incomplete corrections following previous conservative treatment. All patients achieved good clinical results as per Pirani score and authors concluded that differential distraction by fixator was an effective and patient-friendly method of management neglected clubfoot.

When Is the Best Time to Start Treatment?

There is a general impression that Ponseti manipulation should begin in the “first week of life” [28]. However Iltar [29] found that infants in whom correction was commenced after the first month had a better Dimeglio score than those in whom the correction was commenced earlier. There were 29 patients (40 feet) with idiopathic clubfoot in the series. Eighteen patients (26 feet) had Ponseti treatment within the first month of life and the rest had treatment commenced after the first month. Median follow up was 34 months. There was no significant difference in initial Pirani and Dimeglio scores between the two groups. Both groups demonstrated significant improvement following treatment and there was a marginal difference only in Dimeglio score following treatment between the two groups. The authors suggested that the Ponseti treatment should be commenced after the first month of life or when the involved foot is ≥8 cm in length. This was a retrospective study with no control. Although the difference was statistically significant, its clinical value is doubtful. In a recent meeting of the First European consensus meeting the assembled experts agreed that “treatment for clubfoot should start not later than within the first month of life” with the caveat to defer treatment in a premature baby for several weeks to allow for the baby’s foot to grow in size [30].

What Type of Casting Material Should Be Used?

Pittner [31] conducted a trial to compare the effectiveness of plaster of Paris (POP) to semi rigid fibreglass (SRF) in the management of clubfoot. Several methodological flaws have been noted in the study regarding sample size calculation, allocation, concealment and randomisation. Thirteen patients (16 feet) received SRF and 18 patients (23 feet) received POP. The authors used Dimeglio score to describe severity of clubfeet deformity. There was no difference in initial score between the two groups. Although similar number of casts were required in both groups the Dimeglio score was significantly higher in the SRF group on completion of treatment (6.4 vs. 4.1; P = 0.037). There was no difference in the rate of tendoachilles tenotomy between the two groups but two patients in SRF group required surgical soft tissue release. The follow up period is unclear and the authors did not describe relapse rate. However they found that parents preferred SRF over POP.

Hui [32] performed a randomised trial to compare time to clubfoot correction between POP and SRF. They performed a priori sample size calculation and used sealed envelope and computerised randomisation. There were 12 patients (18 feet) in the POP group and 18 patients (26 feet) in the SRF group. There was no difference in Pirani score between the two groups (5.3 SRF, 4.9 POP). There was no significant difference in the number of casts required between the two groups. However relapse was higher in the SRF group (47 %) compared to the POP group (25 %). Need for repeat Ponseti casting and surgery was also higher in the SRF group. However, these were not statistically significant and the authors felt that the higher relapse rate in the SRF group could be due to slightly longer follow up (36 months vs. 24 months for POP group) as well as less compliance with foot abduction orthosis wear in the SRF group (71 % vs. 92 % in the POP group). The authors also noted that parents preferred SRF over POP.

It is not possible to perform a summary estimate of the two trials as they used two different rating systems and it is unclear if the population was similar, the follow up rates were clearly dissimilar and the reported primary outcomes were different. However, it appears that although POP may give better results parents tend to prefer SRF.

Should the Cast Be Applied Below or Above the Knee?

Brewster et al [33] produced a case series of 51 babies with 80 idiopathic type clubfoot treated with a modified Ponseti technique; instead of traditional plaster casts they used below the knee soft casts. Mean follow up was 27 months and mean time to TAT was 8.5 weeks. Twenty-five percent patients did not require TA tenotomy in their series and relapse rate was 6.27 %. There was a single case of cast slippage. The authors felt that their results were comparable to traditional above knee plaster cast technique.

Subsequently Maripuri et al [34] conducted an RCT of below versus above knee casting using the Ponseti technique to compare treatment times and failure rates between the two different casts. There were 17 feet in the above-knee group and 16 feet in the below knee group. Patients were randomised using opaque sealed envelope. Their primary outcome measure was time to readiness for tendoachilles (TA) tenotomy or achievement of full correction. Two or more episodes of plaster slip or more than 8 weeks of manipulation requirement was defined at treatment failure. They undertook a priori sample size calculation and required around 30 feet in each arm of the trial. However, the authors felt compelled to stop the trial early when interim analysis showed a 37.5 % failure rate in the below-knee group. The authors concluded that below knee cast was not suitable for the Ponseti technique. Given the size of these two studies, contradicting results is not a surprise. Moreover, both studies have flaws. Experts warn against early termination of trials on the basis of interim estimation and show with simulation studies that small trials stopped early with few events are likely to result in a large overestimation of treatment effects. Moreover, the techniques may be different between the two studies. Brewster [33] used soft cast and described careful molding above the heel to prevent cast slippage. Maripuri [34] did not describe their technique of cast application. Our recommendation is to use above knee cast. The potential benefits of having a shorter cast may not outweigh the risk of failure associated with uncertainties about below the knee cast.

How Frequently Should Casts Be Changed?

Ponseti originally described weekly manipulations to correct clubfoot deformity [28]. His team subsequently investigated if cast treatment could be successfully shortened due to an increase in number of patients presenting in their centre, who often travelled a long distance and could benefit from a shortened time to correction [35]. Patients were assigned to 5 or 7 days based solely on geography. Ninety percent of patients required five or fewer casts for correction, and there was no difference between groups (P = 0.85). Average time from first cast to TAT was 16 days for the 5-day group and 24 days for the 7-day group (P = 0.001). Relapse rate for compliant patients was similar in both groups. The authors attempted cast changes more frequently at 3–4 days and found feet to be swollen and oedematous. They concluded that changing casts every 5 days was safe, effective and probably the fastest way to achieve correction with minimal side-effects.

Xu [36] published a similar study from China where patients travelling long distance were assigned to twice weekly cast changes (26 patients, 40 feet) and local Beijing patients were assigned to weekly cast changes (20 patients, 32 feet). All patients had idiopathic clubfeet. The baseline and final Pirani scores were similar between the two groups, both groups required similar number of casts (mean 5) and tenotomy requirement was also similar (87.5 %). The time to correction was 21 days in the accelerated regime and 35 days in the regular regime. Mean follow up was 4 years. There were six relapses in the accelerated group and five relapses in the regular group. Xu et al did not experience swelling or oedema with twice weekly cast changes.

Elgohary et al [37] published a quasi-randomised trial from Egypt. Twenty children (34 feet) were treated with the regular regime and 21 children (32 feet) were treated with the accelerated regime. Patients receiving the accelerated regime had cast changes twice a week. Pirani score at baseline and end of treatment were similar between the two groups. Mean number of casts and tenotomy requirement was also similar. The length of follow up was unclear but they had a higher relapse rate that was not significantly different between the two groups (14.7 % regular group vs. 15.6 % accelerated group). Authors noted that children with relapse had presented with a high Pirani score (≥5). They did not record compliance with bracing following correction. Time to correction was significantly shorter in the accelerated group 18.13 ± 3.02 days (11–22 days) compared to the regular group 33.36 ± 6.69 days (21–42 days).

Harnett et al [38] from Malawi compared a standard Ponseti regime with an accelerated Ponseti regime of thrice weekly cast changes. Following a sample size calculation they recruited 40 patients with idiopathic clubfoot (61 feet) into an RCT. Randomisation was computer generated. Following treatment patients were put in foot abduction brace and were followed up for 6 months. Nineteen patients (29 feet) were allocated to the accelerated protocol and 21 patients (32 feet) were allocated to the standard protocol. There was no significant difference in Pirani score before or after treatment between the two groups. Tenotomy requirement was similar in both groups and both required median of five cast changes. Three patients in the accelerated regime had Pirani score >1 at 21 days after treatment. They were crossed over to the standard treatment, all had tenotomy and one required tibialis anterior tendon transfer. Median number of treatment days was significantly shorter with the accelerated regime (16 days vs. 42 days for the standard regime). Thirty-six patients (55 feet) were followed up for 6 months and there was no relapse. The authors concluded that the accelerated protocol of twice weekly cast changes was equally effective as the standard protocol of weekly cast changes.

Other relevant findings were published by Tarrazas-Lafargue et al [39] which demonstrated that removing the cast the night before cast change was associated with a longer treatment duration. It was a retrospective review of 44 patients (63 clubfeet) had their cast removed the night before to allow for skin care. Forty-six patients (66 clubfeet) had cast removed immediately before change of cast. The immediate removal group required less number of casts for deformity correction (mean 5, range 4–10) compared to the early removal group (ten casts, range 4–22).

In summary: there is a reasonable body of evidence to suggest that cast changes can safely be performed less than weekly without risk of any adverse events. Studies that promoted accelerated regime did not investigate rigorously the cost effectiveness and convenience for parents and healthcare providers. Moreover, it is not advisable to remove casts the night before.

How Many Casts Are Required for Correction or When Should One Consider Treatment to Have Failed?

Ponseti had indicated that on average between five and seven casts could be required for correction of deformity, with the last cast worn for 2–3 weeks [28]. A 30-year follow up study of idiopathic clubfoot treated at Ponseti’s centre indicated that between seven and nine casts were required for deformity correction. He wrote that not more than ten casts should be required for correction. Extrapolating data from the RCTs it appears that between four and eight casts may be required for correction of the foot deformity in idiopathic clubfoot. It is notable that in the trials where regular Ponseti regime was compared with the accelerated regime the number of casts required were the same even when the accelerated protocol was employed. A survey of North American surgeons found that median number of casts required for correction was seven. A number of factors may affect how many casts may be required. Dyer and Davis [40] from Manchester found that the number of casts required would depend on the severity of initial deformity as assessed using the Pirani scoring. Time to presentation is also an important factor. The older the patients at presentation the more casting is required [21, 24, 25].

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