The Importance of Having a Single, Dedicated Medical Team to Treat Congenital Talipes Equinovarus Using the Ponseti Method: A Retrospective Analysis of Treatment Outcomes After 3 Years of Follow-up

Abstract

Background:

Congenital talipes equinovarus (CTEV) is a relatively common pediatric orthopaedic disorder and a frequent cause of disability in adult populations. The Ponseti method has emerged as the generally preferred for treating children with CTEV. Strict adherence to this technique’s basic principles is critical to achieving favorable outcomes. In 2013, our institution decided that every case of pediatric CTEV would be treated by a single dedicated medical team. The present study aimed to compare the treatment outcomes of children with CTEV treated using the Ponseti method in period I (multiple surgeons) versus those in period II (single dedicated team).

Patients and Methods:

We included respectively the children with CTEV treated using the Ponseti method in Geneva University Hospitals’ pediatric units from 2007 to 2018. Data on patient demographics, clinical characteristics, and the treatment outcomes were collected. The primary outcome was the number of relapsed feet (treatment failure) after 3 years of follow-up. The 2 periods’ outcomes were compared using χ² and independent Student t-tests. Run charts were used to report yearly rates of complications, minor and major recurrences, treatment failure, brace noncompliance, and feet that underwent tenotomy.

Results:

A total of 48 feet (32 patients) and 42 feet (29 patients) in periods I and II were included. The periods showed similar rates for participants’ characteristics. The run charts illustrated the overall improvements in treatment outcomes in period II. A total of 8 relapsed feet (5 patients) were reported, all during period I.

Conclusions:

Since all the pediatric CTEV patients at our institution began to be treated by a single dedicated medical team, we have observed a decrease in all recurrences and complications and an absence of treatment failure. These results highlight the importance of the continuity of care and strict adherence to the Ponseti method.

Level of Evidence:

Level—III Retrospective comparative study.

Congenital talipes equinovarus (CTEV), also known as clubfoot, is a 3-dimensional deformity of the foot characterized by equines, hindfoot varus, forefoot adductus, and forefoot cavus.¹ It is a relatively common pediatric orthopaedic disorder affecting between 0.56 and 4 children per 1000 live births,^2–4 and, in the long term, it is a frequent cause of disability in adult populations.³ Clubfoot causes the patient to walk on the lateral border of the foot and, in severe cases, with the dorsum of the foot. If untreated, this deformity can result in severe disability with severe sequelae.⁵

One of the most popular treatment options is the Ponseti method, which uses clubfoot manipulation and serial casting.⁵ The Ponseti method has been reported to have good outcomes in 95% of cases.⁶ It is easy to learn, cost-effective, and can achieve significantly better long-term functional outcomes than surgical interventions.^3,7 This technique is associated with fewer surgical revisions,⁸ lower costs, and better long-term functional outcomes than primary soft-tissue release.⁶

A systematic review of the literature reported that cases of relapse ranged from 2% to 40%, with lower rates in studies with follow-up durations of less than 4 years (17%) than in longer studies (32%).⁹ A systematic review reported that relapsed cases were associated with poor brace tolerance and parents with low levels of education or low incomes.¹⁰ Indeed, the level of education seems to be a pertinent factor. If parents understand the treatment, the adherence is improved. The economic context may come second, especially in countries like Switzerland, with social aids.

In contrast, strict adherence to the Ponseti method’s basic principles is essential to achieving favorable outcomes.¹¹ It seems that dedicated coordination of care in a clubfoot treatment program results in fewer major surgical events when continuity of care is ensured.^6,12–15 In 2016, a multicentre study also reported on the importance of having only 1 provider centralizing CTEV treatment and the delivery of care.¹⁴ However, the multicentric design did not exclude the influence of the center. More recently, Carry et al¹⁵ reported that the implementation of a quality improvement program (including a dedicated team) was associated with a decrease in major surgery and improved adherence to established guidelines for CTEV management.

Before 2013, in the absence of a dedicated team, pediatric patients with CTEV in our hospital were managed by several different orthopaedic surgeons who relied on their own personal experiences of the Ponseti method. From 2013 onwards, pediatric CTEV treatments in our institution have been performed by a single dedicated medical team (one pediatric orthopaedic surgeon and several nurses). They attended several educational events (Ponseti method courses) together to fully understand the treatment protocol and its principles, thus ensuring strict adherence to the Ponseti method protocol since that time.

To the best of our knowledge, there is no monocentric study that evaluated the influence of the implementation of a dedicated team to manage CTEV patient care. This dedicated team did not need important support from the hospital, in contrast with the more complex quality program implemented by Carry et al.¹⁵

The present study aimed to compare the treatment outcomes (treatment failure, recurrence, and complications) of children with CTEV who were managed using the Ponseti method in the same hospital by multiple surgeons (before 2013, period I) and by a dedicated team adhering strictly to the Ponseti method and centered on a single surgeon (2013 onwards, period II).

MATERIALS AND METHODS

Study Design and Setting

We retrospectively reviewed the clinical charts of children with CTEV who were treated using the Ponseti method in the pediatric unit of a tertiary university hospital from 2007 to 2018. To reduce bias due to differences in the duration of patients’ follow-up, we only considered outcomes reported in the first 3 years after treatment. These follow-up periods were divided into period I, before 2013, with multiple surgeons involved, and period II, from 2013 onwards, when patients were treated by a single dedicated medical team.

Ethics, Funding and Potential Conflicts of Interest

The local ethics committee approved the study (CER n 2021-00482), and an exemption from consent was permitted for all the patients under the assumption that it would be difficult to retrospectively find the contact details of all the young children included. None of the authors reported any conflicts of interest.

Population

The inclusion criteria were: (1) a confirmed diagnosis of idiopathic CTEV, (2) treatment using the Ponseti method, and (3) the patient’s initial treatment began less than 4 weeks after birth. The exclusion criteria were: (1) a clubfoot deformity treated using techniques other than the Ponseti method, (2) the patient had an associated condition, such as a syndromic patient, a neuromuscular condition, a myelomeningocele or arthrogryposis (nonidiopathic CTEV), (3) the patient’s anticipated follow-up lasted <3 years (children born in the hospital but living in another town, city, or country) and, to avoid missing data, (4) treatment was initiated at another hospital before inclusion.

Intervention

The Ponseti method is a conservative correction widely used for the initial treatment of infants born with CTEV.^5,16 The technique is divided into 2 phases: (1) the casting phase and (2) the bracing phase.

Before 2013 (period I), several surgeons and medical teams in our hospital performed the Ponseti method. From 2013 onwards (period II), the Ponseti method was performed by a single dedicated medical team (a pediatric orthopaedic surgeon and nurses who had attended Ponseti method courses). It should be noted that the dedicated surgeon in period II was present in period I. The other particularity of this intervention during period II was the application of a patient-centered and family-centered method of collaborative care. Indeed, the disorder and its treatment were even discussed during prenatal consultations when the team attempted to identify parents’ concerns and build positive relationships with the families.¹⁷ The Ponseti method’s benefits were explained and emphasized in comparison with the previous technique (posteromedial release).

The Ponseti method’s casting phase consists of several manipulations and long leg-casting.¹⁷ Serial casting is done with above-the-knee casts, as below-the-knee casts cannot maintain the foot’s abduction and external rotation. For the first cast, the first metatarsal must be raised, which means supinating the forefoot to align it with the hindfoot and decrease cavus. The foot should never be pronated. The ensuing casts maintain the foot in pure abduction using counter pressure on the neck of the talus. The calcaneus must not be touched as this might block its motion: it must be free to swing out from underneath the talus and thereby abduct, evert, and dorsiflex. Active dorsiflexion should not be attempted before the subtalar joint is fully corrected and/or until after a tenotomy.^1,12

From 2013 onwards (period II), casting was accompanied by relaxing music to keep the infant as calm as possible during the intervention, and minimal pressure was applied to the foot so as not to disturb it.¹⁸

After the casting phase comes the bracing phase, where a foot abduction brace (FAB) keeps the foot (or feet) in the corrected position. FAB holds the feet in external rotation and dorsiflexion. This should be worn continuously for 3 months, even at night. Then, it should be worn at least 10 to 12 hours per night until the age of 4 to 6 years old.¹⁹ This brace-wearing time instructions were the same for both period I and period II. The bracing phase is a critical component of the Ponseti method, with noncompliance or failure to wear the brace being reported as one of the most significant factors for treatment failure.¹⁰

During period I, our hospital used the traditional Denis Browne bar FAB (which includes pre-walking shoes attached to a rigid metallic bar).²⁰ From 2013 onwards (period II), it used a Mitchell brace (which includes detachable shoes, soft silicone and rigid metallic bar, ankle–foot orthosis-type inserts).²⁰ During this period, the dedicated medical team also emphasized to patients’ families how important the correct use of the brace was to reduce the brace noncompliance rate.

Data Collection

A single researcher retrospectively retrieved data from the medical charts of children with CTEV who had been treated in our hospital using the Ponseti method from 2007 to 2018. The patient characteristics assessed at baseline were sex, positive family history of CTEV, perinatal complications, the extremity involved, and the severity of the deformity. The severity of CTEV at birth was assessed using the Dimeglio score, which is classified as mild (I: score of <5 points), moderate (II: score ≥5 and <10 points), severe (III: score ≥10 and <15 points), or very severe (IV: score ≥15 points).²¹

The outcomes recorded during the casting phase were the age at the first cast, the number of casts used, the number of complications (eg, skin infection, cast slippage, cast intolerance, erythema, pain, a wet cast, skin breakdown, swollen toes, the subject physically kicking off the cast), and the numbers of cast revisions and re-casts needed. The outcomes recorded during the bracing phase were the number of brace complications (eg, pain, bedsores, poor tolerance), noncompliance with treatment recommendations, and premature removal of the brace (before 3 y old).

Any additional treatments needed during the 3 years of follow-up (eg, tenotomy, tibialis anterior transfer, Achilles tendon relengthening, posterior release) were also reported.

Finally, the outcomes recorded after 3 years of follow-up were relapsed foot, the external rotation and dorsiflexion angles, any physical limitations to the child’s activities (subjectively evaluated by their parents), any requirements for physiotherapy, and the presence of a complex foot deformity or leg-length inequality.

Outcomes

The primary outcome was the number of treatment failures with relapsed feet (inability to maintain a plantigrade position) after 3 years of follow-up. The secondary outcomes were the numbers of minor and major recurrences defined according to the method described by Carry et al.¹⁵ Minor recurrences were defined as any recurrences resulting in deviations from the routine follow-up protocol, including repeat casting, revision tenotomy, and tibialis anterior tendon transfer. Major recurrences were defined as any recurrence requiring extensive soft-tissue release surgery or bone procedures that went beyond repeat tenotomy and/or tendon transfers.

Analysis

All the statistical analyses were done using R software (version 3.5.2) and related packages (R Development Core Team, 2018). Demographics, clinical characteristics, and rates of complications were compared over the 2 periods using χ² and independent Student t-tests. Run charts were added to report yearly rates of complications, minor and major recurrences, relapsed foot, brace noncompliance, and feet that underwent tenotomy. The median yearly rates for periods I and II were compared using unpaired Wilcoxon tests. The level of significance was set at P<0.05.

We used univariate and multivariate Firth’s logistic regression analysis (with profile penalized log-likelihood method), adjusted for age at first cast and baseline Dimeglio clubfoot severity (classification I/II/III vs IV) to calculate unadjusted and adjusted odds ratios (ORs), with 95% confidence intervals (95% CIs), for treatment failure and minor and major recurrences to compare patients treated during period I with those treated in period II. To limit any bias due to the inclusion of subjects with bilateral CTEV, we included the foot with the worst outcome measures.

RESULTS

Participants

A total of 61 patients (90 feet) were included, with 32 patients (48 feet) and 29 patients (42 feet) in periods I and II, respectively. The 2 periods showed similar rates for participants’ sex, positive family history, perinatal complications, bilateral clubfoot, and baseline Dimeglio clubfoot severity scores (Table 1). A total of 10 surgeons were involved during period I, with 4 patients (6 feet) treated by 2 surgeons during the 3 years of follow-up.

TABLE 1.

Comparison Between Patients and Clubfeet Treated by Multiple Surgeons or a Single Dedicated Medical Team

				Group comparisons
	All (n=90 CF, 61 patients)	Period I (n=48 CF, 32 patients)	Period II (n=42 CF, 29 patients)	P	95% CI
Baseline patient characteristics, [no. patients (%)]
Female sex, n (%)	32 (36)	16 (33)	16 (38)	0.803	−27 to 17
Positive family history, n (%)	10 (11)	2 (4)	8 (19)	0.057	−30 to 1
Perinatal complications, n (%)	12 (13)	7 (15)	5 (12)	0.950	−14 to 19
Extremities involved, n (%)
Unilateral	32 (36)	16 (33)	16 (38)	−	−
Bilateral	58 (0)	32 (67)	26 (62)	0.803	17 to 27
Baseline clubfoot characteristics [no. feet (%)]
Dimeglio severitya
Low–Moderate (I–II, <10)	8 (9)	4 (8)	4 (10)	−	−
Severe–Very severe (III–IV, ≥10)	78 (86)	41 (85)	37 (88)	0.950	−19 to 14
Casting phase [no. feet (%)]
Age at first cast, wks	1.7 (1.0)	1.5 (1.1)	1.9 (0.8)	0.027	−0.8 to −0.1
Number of casts, mean (SD)	6.2 (1.5)	6.5 (1.8)	5.9 (1.0)	0.049	−0.0 to 1.2
Cast complications, n (%)	15 (17)	15 (31)	0 (0)	<0.001	16 to 47
Cast revisions, n (%)	12 (13)	12 (25)	0 (0)	0.002	11 to 39
Re-casts, n (%)	16 (18)	16 (33)	0 (0)	<0.001	18 to 49
Bracing phase [no. feet (%)]
Brace complications, n (%)	25 (28)	20 (42)	5 (12)	0.004	10 to 49
Noncompliance, n (%)	16 (18)	11 (23)	5 (12)	0.277	−7 to 28
Stopped before 3 y old, n (%)	6 (7)	6 (12)	0 (0)	0.065	−0 to 23
Other treatments [no. feet (%)]
Underwent tenotomy, n (%)	86 (96)	44 (92)	42 (100)	0.161	−18 to 2
Age at tenotomy, mo	2.1 (0.7)	2.2 (0.9)	2.0 (0.2)	0.125	−0.1 to 0.5
TA transfer, n (%)	6 (7)	5 (10)	1 (2)	0.271	−4 to 20
AT relengthening, n (%)	5 (6)	5 (10)	0 (0)	0.091	−1 to 21
Posterior release, n (%)	9 (10)	9 (19)	0 (0)	0.009	5 to 32
3 y follow-up [no. feet (%)]
Treatment failure, n (%)	8 (13)	8 (17)	0 (0)	0.016	4 to 29
External rotation, deg	50.5 (10.8)	46.8 (11.4)	54.0 (8.0)	0.002	−11.8 to −2.8
Dorsiflexion, deg	14.9 (6.3)	12.6 (6.3)	17.6 (5.3)	<0.001	−7.4 to −2.6
Complex clubfoot, n (%)	1 (1)	1 (2)	0 (0)	>0.999	−4 to 8
Limited physical activity, n (%)	6 (7)	6 (13)	0 (0)	0.051	−0 to 24
Physiotherapy, n (%)	37 (41)	31 (65)	6 (14)	<0.001	31 to 70
Leg-length inequality, n (%)	2 (3)	2 (4)	0 (0)	0.535	−4 to 12

Period I is before 2013 (multiple providers), Period II is 2013 onwards (single dedicated medical team). Statistical tests used were the Student t-tests for continuous outcomes (mean (standard deviation)) and chi-squared tests for dichotomous outcomes [n (%)].

Significant differences between groups were considered at P<0.05.

^aFour patients with missing data in period I.

AT indicates Achilles tendon; CF, clubfoot; n, number; TA, tibialis anterior.

Treatment Outcomes

The run charts (Fig. 1) illustrated the overall improvements in treatment outcomes from 2013 onwards (period II). There was a significantly lower yearly rate of treatment failure with relapsed feet (Fig. 1-A, P=0.04), minor/major recurrences (Fig. 1-B, P=0.01), brace complications (Fig. 1-C, P=0.02), and cast complications (Fig. 1-D, P=0.02). The yearly rates of noncompliance (Fig. 1-E) and the proportion of feet that underwent tenotomy (Fig. 1-F) were not significantly different between the 2 periods (P>0.05).

FIGURE 1.

Run chart of (A) treatment failure (relapsed clubfoot), (B) minor or major recurrences, (C) cast complications, (D) brace complications, (E) noncompliance with brace, (F) Tenotomy. The x-axis represents time (y), the y-axis represents the yearly rate, and the dashed lines represent the median incidences of the respective outcomes during period I (before 2013, multiple surgeons) and period II (2013 onwards, single dedicated team). Medians with interquartile ranges were reported for periods I and II, and p values correspond to unpaired Wilcoxon tests. The level of significance was set at P<0.05. A lower incidence represents a positive outcome. The sample size is the number of clubfeet each year.

A total of 8 treatment failures with relapsed feet (5 patients) were reported—all during period I (Table 2, Fig. 1-A). Most of them (3/5 patients) were bilateral foot involved of the same patient, and only 1 patient (both feet) had a Dimeglio clubfoot severity score of less than 15 (<classification IV: very severe) (Table 2). They all (8 feet) had brace complications, with the majority of cases (except 2 patients, 3 feet) reporting cast complications and noncompliance with brace usage. One patient (with bilateral clubfoot but just 1 relapsed) presented with a complex clubfoot.

TABLE 2.

Details of Treatment Failure With Relapsed Feet (inability to maintain a plantigrade position) After 3 Years of Follow-up

Patients	#1	#2	#3	#4	#5	#6	#7	#8
Relapse description
Patient ID	#9	#9	#30	#32	#32	#72	#77	#77
Side of relapsed foot	R	L	L	R	L	L	R	L
Bilateral foot involvement	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes
Both feet relapsed	Yes	Yes	No	Yes	Yes	No	Yes	Yes
Patient’s sex	F	F	M	M	M	F	M	M
Family history	Yes	Yes	No	No	No	No	No	No
Perinatal complications	Yes	Yes	No	No	No	No	Yes	Yes
Dimeglio severity	16	17	18	16	16	16	11	11
Period I or II	I	I	I	I	I	I	I	I
Cast treatment
Age at first cast, wks	5	5	0	0	0	1	4	4
No. casts	11	11	6	8	8	6	8	8
Cast complications	Yes	Yes	Yes	Yes	Yes	No	No	No
Cast revisions	Yes	Yes	Yes	Yes	Yes	No	No	No
Re-casts	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Brace treatment
Brace complications	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Noncompliance	Yes	Yes	Yes	Yes	Yes	No	No	No
Stopped before 3 y	No	No	No	No	No	No	No	No
Other treatment
Underwent tenotomy	Yes	Yes	Yes	Yes	Yes	Yes	No	No
Age at tenotomy, mo	4	4	2	2	2	2	–	–
TA transfer	No	Yes	Yes	Yes	Yes	No	No	No
Age at TA transfer, mo	–	2	3	3	3	–	–	–
AT relengthening,	Yes	Yes	No	Yes	Yes	Yes	No	No
Posterior release	Yes	Yes	Yes	No	No	No	No	No
Age at PR, years	1	2	1	–	–	–	–	–
Follow-up result
External rotation, deg	40	40	40	40	40	60	30	30
Dorsiflexion, deg	0	0	10	5	0	15	15	15
Complex clubfoot	No	No	Yes	No	No	No	No	No
Limited physical activity	Yes	Yes	Yes	Yes	Yes	No	No	No
Physiotherapy	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes
Leg-length inequality	No	No	No	No	No	No	N/A	N/A

Period I is before 2013 (multiple providers), Period II is 2013 onwards (single dedicated medical team).

AT indicates Achilles tendon; ID, identified; PR, posterior release; TA, tibialis anterior.

As reported in Table 3, univariate Firth’s logistic regressions showed that, compared with period I, period II’s ORs were significantly lower for a treatment failure with relapsed foot [OR=0.09 (0.00; 0.86), P=0.034], a minor recurrence [OR=0.03 (0.00; 0.25), P<0.001] and a major recurrence [OR=0.02 (0.00; 0.20), P=0.008]. Multivariate logistic regressions adjusted for age at first cast and Dimeglio clubfoot severity at baseline (classification I/II/III vs IV) confirmed that period II’s treatment outcomes were significantly better (P<0.05) than period I’s.

TABLE 3.

Univariate and Multivariate Logistic Regression Analyses of Treatment Failure (relapsed feet), Minor Recurrences, and Major Recurrences in Patients Treated in Period I (before 2013, multiple surgeons, n=32 patients) and Period II (2013 Onwards, Single Dedicated Medical Team, n=29 Patients)

Outcome	Odds ratio	95% CI	P-value
Treatment failure (relapsed foot) (n=5 patients)
Single dedicated team (unadjusted)	0.091	[0.001; 0.863]	0.034
Single dedicated team (age-adjusted)	0.075	[0.001; 0.721]	0.021
Single dedicated team (clubfoot-severity-adjusted)	0.057	[0.004; 0.594]	0.012
Single dedicated team (age + severity-adjusted)	0.045	[0.003; 0.485]	0.007
Minor recurrence (n=12 patients)
Single dedicated team (unadjusted)	0.030	[0.001; 0.252]	<0.001
Single dedicated team (age-adjusted)	0.026	[0.001; 0.228]	<0.001
Single dedicated team (clubfoot-severity-adjusted)	0.024	[0.001; 0.223]	<0.001
Single dedicated team (age + severity-adjusted)	0.021	[0.001; 0.199]	<0.001
Major recurrence (n=7 patients)
Single dedicated team (unadjusted)	0.062	[0.002; 0.552]	0.008
Single dedicated team (age-adjusted)	0.055	[0.004; 0.492]	0.005
Single dedicated team (clubfoot-severity-adjusted)	0.043	[0.003; 0.412]	0.003
Single dedicated team (age + severity adjusted)	0.037	[0.003; 0.365]	0.002

Statistical analyses used univariate and multivariate Firth’s logistic regressions (with the profile penalized log-likelihood method), for which unadjusted and adjusted odds ratios, respectively, and 95% confidence intervals (95% CI) were calculated. We contrast period II (from 2013 onwards, single dedicated medical team) to period I (before 2013, multiple surgeons), contrasting for age at first cast is 1-week-increase and contrasting for foot severity using the Dimeglio baseline classification I/II/III (<15) vs IV (≥15). Odds ratios were adjusted for the number of predictors in the model. The significance level was set at P<0.05. Treatment failure (relapsed clubfoot) is the inability to maintain a plantigrade position at the 3-year follow-up. Minor recurrence is a re-cast and/or TA relengthening and/or anterior tibial tendon transfer. Major recurrence is other surgery. To limit bias due to the inclusion of subjects with bilateral clubfoot, we included the foot with the worst outcome.

DISCUSSION

Our study revealed the significant improvements and better outcomes resulting from handing over the treatment management of infant CTEV to a single dedicated medical team using the Ponseti method. These results could have a high impact on the patient's quality of life and the cost for the institution. Indeed, this change in our hospital procedures led to decreases in minor recurrences (35% period I vs. 2% period II), major recurrences (19% period I vs. 0% period II), cast complications (31% period I vs. 0% period II) and brace complications (42% period I vs. 12% period II). We also found no reports of treatment failure in period II, compared with 17% in period I. These results were confirmed, even after correction for age at first cast and baseline clubfoot severity score.

These results were in line with the improvements reported by Carry et al¹⁵ after the introduction of a quality improvement program (including a dedicated team trained in the Ponseti method) to improve treatment quality. They reported a 76% reduction in the odds of recurrence when care teams adhered to the clinical care pathway, indicating that adherence was a route to better outcomes. They also reported that subjects were more likely to be treated with more than 3 providers during phase I, but they did not evaluate the influence of a single dedicated provider by patient (continuity of care). The implemented quality program was more complex than a simple, dedicated team. It needs ongoing support from the hospital and department leadership. The results of the present study may be generalizable to other hospitals, in contrast to the results of the Carry et al study.¹⁵

A similar lower rate of major recurrences was reported in the multicentre study by Miller et al,¹⁴ with a 2% rate of recurrences in the hospital center using a single surgeon compared with a 47% rate of unplanned surgery in the hospital center using 16 different surgeons. A total of 8 cases of treatment failure with relapsed feet (13%) were reported in 5 patients, all treated in period I. The present study results are more generalizable because all the patients were included at the same institution with similar patient profiles, in contrast with the results of the Miller et al¹⁴ study.

The present results are in line with relapse rates of 17% reported in a recent systematic review of 39 studies with a follow-up of <4 years.⁹ It should be noted that this rate increased to 32% when the follow-up was ≥4 years (including 23 studies).

Most of the cases of relapse in the present study (7/8 feet, 88%) involved bilateral clubfeet with severe-to-very severe initial Dimeglio scores (>10). They all had brace complications, which involved noncompliance in 5/8 (63%) feet. The literature reports poor brace tolerance as a major factor in noncompliance, with other factors including parents on a low income or with a low level of education.¹⁰ These cases reveal why good communication with patients’ families is essential—it has been shown that communication errors with families can have a direct impact on brace compliance. Brace compliance should be considered as a complex, multifactorial issue.

The change in the type of brace used (from the Denis Browne bar to the Mitchell brace) may also help to explain period II’s better clinical outcomes. The Mitchell brace was initially designed, under the direction of Dr Ponseti, for the treatment of complex clubfeet. It rapidly became popular in developed countries thanks to its very comfortable shoes.^20,22 Nevertheless, the literature reports that treatment adherence and compliance with bracing protocols are not influenced by a brace’s type or design.²³

The literature review by Youn et al presented the most common errors in CTEV management.¹⁶ They made clear that the Ponseti method is a surgical procedure requiring close attention to several details (eg, the manipulation procedure, skin maceration and abrasion, complications during tenotomy procedures) and that there is a significant learning curve in managing this deformity correctly. The continuity of care ensured by having a single dedicated medical team for treating clubfoot—and the consequent learning curve that they will follow by repeatedly using this method—should also improve communication with families and their trust in those surgical teams.^6,12–14 Indeed, good communication with the family is essential to establishing a trusting relationship and being able to influence their behavior, educate them about the disorder, and ensure that they are the principal partners in their child’s treatment.²⁴ These ideas are all in line with the patient-centered and family-centered collaborative care model in pediatric orthopaedics.^25,26

The relaxing music played during cast room procedures could also partially explain the better clinical outcomes in period II, thanks to the reduced level of anxiety that makes the casting process more pleasant for medical teams, patients, and families.¹⁸

This work had some limitations. The main limitation to our analysis was that several changes were implemented from 2013 onwards (period II), including the use of a single dedicated medical team, the application of patient-centered and family-centered collaborative care methods, the use of relaxing music during cast procedures, and the change in the type of FAB (to a Mitchell brace). It was thus impossible for us to distinguish the specific effects of each change in treatment management made during period II. It should also be noted that we cannot exclude the fact that the lead surgeon in period II is the most interested and the most experienced with his participation in both periods (I & II). Even if the sample size is low to conclude, it seems that the clinical outcomes were similar between surgeons in period I. Secondly, the sample size was relatively restricted as our hospital generally treats less than 10 patients annually. These results should be confirmed using a larger cohort. In larger institutions with more patients per year (>50 kids), the dedicated team could include more than 1 surgeon. However, continuity of care for each patient should be respected. It is also possible that the 3-year follow-up time was too short to evaluate relapse rates appropriately. One recent systematic review reported a significant increase in relapse rates with follow-up going beyond 4 years of age.⁹ Indeed, future studies could extend follow-up beyond 4 years, as recommended by Gelfer et al⁹ Lastly, the present study did not report costs. Future studies should evaluate any potential cost reductions to quantify the short-term and long-term benefits of having 1 dedicated medical team for treating all cases of CTEV.

CONCLUSION

Following our hospital’s decisions to have just 1 dedicated medical team for treating cases of CTEV and to send it on several courses about how to adhere strictly to the Ponseti method, we observed significant decreases in all recurrences and complications of clubfoot and no more cases of treatment failure. These improvements in clinical outcomes could have a high impact in the patient's quality of life and the cost for the institution. These results highlight the importance of strict adherence to the Ponseti protocol, robust continuity of care, and the involvement of patients’ parents. These results should be validated in a larger cohort with extended follow-up beyond 4 years.