Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus: a cohort study.

Panji Sananta; Respati Suryanto Dradjat; Tofan Margaret Dwi Saputra; Muhammad Alwy Sugiarto

doi:10.12688/f1000research.109284.1

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Research Article

Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus: a cohort study.

[version 1; peer review: 3 not approved]

Panji Sananta ¹, Respati Suryanto Dradjat¹, Tofan Margaret Dwi Saputra¹, Muhammad Alwy Sugiarto¹

PUBLISHED 29 Mar 2022

Author details Author details

¹ Orthopeadic and Traumatology Department, Brawijaya University, Malang, East Java, 65111, Indonesia

Panji Sananta
Roles: Conceptualization, Data Curation, Formal Analysis

Respati Suryanto Dradjat
Roles: Conceptualization, Supervision, Validation

Tofan Margaret Dwi Saputra
Roles: Investigation, Project Administration, Resources

Muhammad Alwy Sugiarto
Roles: Software, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background:Neglected congenital talipes equino varus (CTEV) deformity is common in poorer developing countries. If ignored, children with CTEV result in callosity, potential bone and skin infection, and a significant mobility limitation resulting from stiffness. There are many management options that can be used to manage neglected CTEV. Until now, the Ponseti casting technique is a gold standard for treating CTEV without surgery. Ponseti methods effectively correct CTEV deformity in all ages. However, patients treated with the Ponseti process will suffer pain during correction in daily practice. Therefore, it is necessary to give anesthesia to reduce pain and relax soft tissues to achieve a satisfactory outcome when correction is carried out.
Methods:This study design is a retrospective. Our study consisted of 32 patients, divided into two groups. Group A is the group that was treated with the Ponseti using general anesthesia (GA), and group B is the group without using GA. The children were anesthetized using isoflurane inhalation with 1-2 mcg/kg. After that, we performed serial casting every week and evaluated the outcome and number change cast between using GA and without GA. Lastly, we used a paired t-test statistical analysis to determine the relationship between before and after therapy.
Results:In group A, the mean Pirani score significantly reduced from 5.81 ± 0.403 to 0.625 ± 0.40. In contrast with roup B, where the mean Pirani score slightly decreased from 5.81 ± 0.403 to 4.437 ± 1.093. After the last serial cast, in group A, only four cast replacements were needed to achieve a good outcome, whereas, in group B, the results remained unsatisfactory after 10 cast changes.
Conclusions:
Ponseti method under GA is an effective treatment and reduced the number of cast changes for neglected CTEV.

Keywords

Clubfoot, Congenital Talipes Equino Varus, Neglected, Walking Age, Children, General Anesthesia.

Corresponding author: Panji Sananta

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2022 Sananta P et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Sananta P, Suryanto Dradjat R, Dwi Saputra TM and Sugiarto MA. Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus: a cohort study. [version 1; peer review: 3 not approved]. F1000Research 2022, 11:361 (https://doi.org/10.12688/f1000research.109284.1) First published: 29 Mar 2022, 11:361 (https://doi.org/10.12688/f1000research.109284.1) Latest published: 29 Mar 2022, 11:361 (https://doi.org/10.12688/f1000research.109284.1)

Introduction

The congenital talipes equinovarus (CTEV) is one of the most frequent and complex congenital deformities.¹^,² The incidence of CTEV is estimated to be 1 to 2 per 1,000 live births.³^,⁴ CTEV has four components: ankle equinus, hindfoot varus, forefoot adductus, and midfoot cavus.⁵ When ignored in children, CTEV can result in callosity, potential bone and skin infection and a significant mobility limitation resulting from stiffness.⁶^,⁷ In older patients with CTEV, the soft tissue becomes fixed and more difficult to manage.⁸ This condition is usually found in neglected CTEV deformity.

Neglected CTEV is a common issue in poorer developing countries.⁶ The terminology neglected CTEV is somewhat unclear. According to some previous studies, neglected CTEV is not treated until the age that most treatments are expected to be successful deformity correction, in which optimally start straight from birth.⁷^,⁹ Subsequently, neglected CTEV may be defined as any CTEV which has not received any treatment before the age of 2 years.⁸^,¹⁰ In developing countries, late presentation causes neglected conditions commonly due to a lack of awareness, treatment availability, or referral delays, and many parents choose to postpone treatment to seek traditional treatments(i.e. massage management).¹¹

There are many options that can be used to manage neglected CTEV deformities, such as the Ponseti casting technique, Achilles tenotomy, Achilles tendon lengthening, plantar fasciotomy, etc.⁹ Over the last two decades, the Ponseti casting technique has become the gold standard for treating CTEV without surgery.⁵^,¹² The Ponseti method of serial casting has increased in popularity due to its effectiveness in correcting all components of CTEV in over 90% of cases.¹^,⁵^,⁶^,¹³ Despite this, another study reported that Ponseti also had weaknesses, although in small numbers such as leg discrepancies or reccurence.¹³^,¹⁴

Ponseti methods effectively correct CTEV deformity in all ages. However, in daily practice, patients treated with the Ponseti method will suffer pain during correction.⁸^,¹⁵^,¹⁶ Furthermore, the neglected condition in an older child created difficulties correction due to stiffness and problem gait pattern.¹⁷ Therefore, it is necessary to give anesthesia to reduce pain and relax soft tissues to achieve a satisfactory outcome when correction is carried out.

To our knowledge, only a few studies discuss the outcome using the ponseti correction method with general anesthesia (GA), especially in a neglected condition. Therefore, the purpose of this study was to evaluate the outcome of Ponseti casting for neglected CTEV with GA if compared without using GA. The authors hypothesize that the result will be better with GA, especially in neglected patients. This article has followed STROBE checklist and guidelines.

Methods

Ethical considerations

This study was approved by The Ethical Committee of the Medical Research Faculty of Universitas Brawijaya with number 400/036/K.3/302/2022. Informed consent was obtained verbaly from patient’s guardians for collection of the data for this study. Written infformed consent was obtained from the patient’s guardians for the publication of the data collected.

Study design

This study design is a cohort retrospective study using medical records as secondary data. The population in this study is patients who underwent Ponseti methods at Saiful Anwar Hospital, Malang, from January 2017 until December 2019. From medical records, we collected data on the age, sex, pirani score before and after ponseti method, and total number of cast change.

The total patient with neglected CTEV admitted to our hospital between January 2017 and December 2019 were 35 patient, but 3 patient were excluded by the exclusion criteria. two patient were treated with traditional treatment, and the data was incomplate in one patient. The final total sample of the study was 32 patients which consisted of 16 patients who had been treated with the Ponseti method using GA and 16 patients treated with Ponseti without GA (those whos gaurdians opted against using it). Therefore, we divided the sample into two groups, group A and Group B. In group A, isoflurane inhalation with doses of 1-2 mcg/kg were used as GA drugs. All patients either unilateral or bilateral using ponseti methods for CTEV repair with the supine position.

Eligibility criteria

Inclusion criteria were patients over two years old with congenital talipes equinovarus and consent to participate. Exclusion criteria included neurological problems, spine or hip disorder, and children treated with other methods before performing Ponseti Method such as traditional treatment, incomplete medical records data.

Outcome measures

The severity of deformity result was assessed using the Pirani scoring system at the beginning and end of treatment. Figures 1 and 2 provide examples of before and after treatment. two independent general practicion who did not contribute on this study collecting data to prevent bias; however, Ponseti correction was performed by a single orthopaedist in a Tertiary Hospital. Based on the Pirani score, the foot was given a score between 0 and 6. The cases of 32 children with CTEV had been treated and observed for one year. The serial casting was performed every week for manipulation, and the number of casting changes for the treatment was also evaluated. The cast was made using plaster of paris, and strengthened with fiberglass as an outer layer to prevent it from breaking in older children.³ The minimum number of casts used was four and the maximum number of cast changes was 12.¹⁷

Figure 1. Clinical picture before Ponseti cast with general anasthesia.

Figure 2. Clinical picture after Ponseti cast with general anasthesia.

When the last cast was removed, the outcome follow up was carried out for one month. The parents were instructed to follow a home-based exercise program. The exercise program included 50 repetitions of dorsiflexion and foot abduction exercises, which were to be repeated five times daily for the first two years and then three times daily.¹⁸ We divided the outcome scores (recorded at the time treatment was completed) between 0 and 1 were excellent, between 1.5 and 2.5 for good score and scores > 3 for poor score after treatment.¹⁸

Statistical analysis

The statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) Version 23.0 (RRID:SCR_002865). The demographic data and other characteristics were measured in terms of numbers and percentages. A paired t-test was used to determine differences in Pirani scores between treatment groups. We also performed a chi-square test to evaluate the difference hypothesis between the two groups. The significance value < 0.05 was considered statistically significant with sensitivty 95% confidence intervel.

Results

Description of patient

In this study, the total number of patients included is 32. There were 18 females (56.3%) and 14 male (43.8%). The mean age of all patients in this study is 8.937 ± 5.22, with the range age between 2 to 24 years old. The most common age group was 6-10 years with 11 Patients (34.4%) (Table 1). The distribution of group A (group with GA) is 6 male children and 10 female children with an average age of 9.5 ± 5.83. Then, in group B (group without GA), 8 patients are male, and 8 patients are female. In groupB, the mean age is 8.37 ± 4.66. An example of a patient before treatment is shown in Figure 1.

Table 1. Distribution of patients.

	Sex		Age (years)				Side		Total feet
	Male	Female	2-5	6-10	11-15	>15	Unilateral	Bilateral
Group A n(%)	6 (37.5)	10 (62.5)	4 (25.0)	5 (31.3)	5 (31.3)	2 (12.5)	8 (66.6)	4 (33.3)	16
Group B n(%)	8 (50.0)	8 (50.0)	5 (31.3)	6 (37.5)	4 (25.0)	1 (6.3)	10 (76.0)	3 (23.0)	16

Pirani score with GA and without GA

Pirani score with GA

This study categorized the distribution age of children with CTEV under GA as group A. There are 4 children in the age group of children 2-5 years that consists of one child (25%) with Pirani 5, and 3 children (75%) with Pirani score 4. Then, there are 5 children in the age group 6-10 years that all (100%) have a Pirani score of 5. And then, there are five children in the age group 11-15 years that consists of is two children (40%) with a Pirani score of 2 and three children (60%) with a Pirani score of 3. Lastly, for age over 15 years old, there are two patients in this group, 16 years and 24 years old, these patients had the same Pirani score of 6. In group A, the mean Pirani score before the Ponseti cast was 5.81 ± 0.403. Subsequently, after the Ponseti treatment with GA, the Pirani score reduced with mean was 0.625 ± 0.403 (Table 2).

Table 2. Difference Pirani score between using general anesthesia (GA) and without GA.

Age	Pirani	Group A		Group B		P1	P2
Age	Pirani	Initial visit	Final follow-up	Initial visit	Final follow-up	P1	P2
2-5	Excellent (0-1)	-	4 (25.0)	-	-	0.000^a t:40.5	0.000^b t:5.3
	Good (1.5-2.5)	-	-	-	-
	Poor (>3)	4 (25.0)	-	5 (31.3)	5 (31.3)
6-10	Excellent (0-1)	-	5 (31.3)	-	1 (6.3)
	Good (1.5-2.5)	-	-	-	-
	Poor (>3)	5 (31.3)	-	6 (37.5)	5 (31.3)
11-15	Excellent (0-1)	-	5 (31.3)	-	-
	Good (1.5-2.5)	-	-	-	-
	Poor (>3)	5 (31.3)	-	4 (25.0)	4 (25.0)
>15	Excellent (0-1)	-	2 (12.5)	-	-
	Good (1.5-2.5)	-	-	-	-
	Poor (>3)	2 (12.5)	-	1 (6.3)	1 (6.3)

a Paired t test result group A.

b Paired t test result group A.

We evaluated the number of cast replacements for the patients the range was restricted from 4 to 12 times. In this group Ponseti mean cast change 4.125 ± 1.50 to achieve a satisfactory result shown in Figure 2 (a Pirani score of between 0 and 1).

Pirani score without GA

Pirani score without GA was categorized as group B. Similar to group A, we divide the distribution into four categories. In group B, there are five children in the age range 2-5 years old that consists of four children (75%) with Pirani score 6 and one child (25%) with Pirani 5. Then, there were five children in the age group 6-10 years that consisted of three children (50%) with a Pirani score of 6, two children (33.3%) with a Pirani score of 5, and one child (16.7%) with Pirani 4.For the age group 11-15 years, there were four children (100%) that had a Pirani score of 6. Lastly, for over 15 years old, there was only one patient (100%) who had a Pirani score of 6. Unlike the results above, the outcome after the Ponseti method did not achieve satisfactory results. In group B, we obtained the Pirani score before the Ponseti cast mean of 5.81 ± 0.403. Hereafter, Pirani score after the Ponseti treatment without GA was only slightly reduced, with a mean was 4.437 ± 1.093.

In this group, the ponseti mean cast change was 10.25 ± 3.53, even after 12 serial casting the condition of foot of group B patient can not achieved good outcome. (Table 2) Eventually, after Ponseti cast management using GA (group A), the Pirani score significantly (p < 0.000) achieved an excellent outcome (Pirani score 0-1) in all patients (100 %) after the last serial cast was performed (group A). In contrast, when the Ponseti method is used without GA (group B), 15 patients (93.8%) did not achieve a reduction in their condition and remain in a poor outcome status (Pirani score > 3). Fortunately, at least one patient in group B (6,3%) had improved to be in good status after the final follow-up (p < 0.000).

Discussion

Several other studies reported satisfactory clinical outcomes using the Ponseti method, which requires a series of procedures and serial sets of casting.¹³^,¹⁵^,¹⁹ The treatment needs to be started as soon as possible and should be followed under close supervision. At an early age, the outcome of the Ponseti casting technique yielded satisfactory anatomical and functional results with simple, effective, minimally invasive, inexpensive, and shor duration to achieve correction.⁵^,²⁰ This is the opposite in the case of the neglected condition, where the soft tissue becomes rigid when treatment is started.⁸ Moreover, according to the author's experience, children over four years old often seem scared of undergoing treatments such as serial casting, which increases the initial stiffness. Therefore, in older children the outcome may not be optimal.

In this study, excellent clinical outcome was achieved using Ponseti methods under GA (group A) on 16 patients (100%), although this was only confirmed in severe cases. This finding is consistent with Hallaj-Moghaddam (2015), who stated that the Ponseti method of manipulation and casting is beneficial in severe clubfoot.²¹ His study was also conducted using general anastesia, for a satisfactory outcome.²¹ From the current study in group A, satisfactory outcomes were reached with an average of four cast replacements; whereas in group B, after an average of ten cast changes, the outcomes remained unsatisfactory.

Sometimes, Ponseti’s classic manipulative technique does not correct some feet, this is especially common in neglected cases in older patients. These feet are clinically characterized by an extremely stiff equinus, severe plantar flexion of all metatarsals, and the perception of a shortened foot even after several casting serial performances.⁴ In this study, we found that 15 patients (93.8%) who did not receive anesthesia (group B) did not receive a satisfactory correction. The authors assume this outcome is due to the patient experiencing pain, also there will be an increase in soft tissue tension. So that, the manipulation and correction of the deformity will not be optimal and affect the outcome of Ponseti management.

In a study by Pavone et al., the average of pirani score result was 5.56, therefore, his result suggest for percutaneus tenotomy. After casting and tenotomy was perfomed, 98.78% patients had normal passive range of movement.²² Unfortunately, in this study, we were limited to discussing the outcomes of conservative clubfoot management with the Ponseti method only without comparing the outcomes using ponseti with tenotomy. Hereafter, because of unsuccessful treatment, in this study, 16 participants in group B underwent tenotomy to repair their clubfoot condition.

Before Ponseti casting started, patients underwent foot manipulations held for a few minutes before casting to help the soft tissue structures relax prior to applying an above-knee cast.²³ However, in some cases, where a patient has neglected clubfoot, the soft tissue is rigid and difficult to correct. If this is forced, it will cause severe pain. Several anesthetic techniques have been utilized from previous issues, including local anesthesia, GA, and spinal anesthetic to reduce rigidity.²⁴^–²⁶

Some previous studies used general anastesia for management of CTEV in adults as used by Ponseti during the first years of treatment. Parada (2009) stated that GA could be administered safely to children who underwent clubfoot management.²⁶ In another study conducted by Haje (2020), he succesfully treated adult patients with neglected CTEV using the Ponseti method under GA.¹⁰

In this decade, various studies have shown that GA for children is totally safe.²⁶^,²⁷ In this study, an inhalation anesthesia agent that is reported as having a lower risk of postoperative apnea in children was used.²⁷ This finding is in line with the research that we have done, in which hospitalization was necessary for no more than one day in all patients who received GA without any complications to be reported.

This study has several limitations, such as the small sample in our study and the short follow-up period. Therefore, a further study long-term follow-up and a significantly larger sample size are recommended. On the others hand, the strength of this study can be reference for another study who discuss Ponseti method in neglected cases, and then this can help clinician about management that can be choosen for neglected CTEV cases.

Conclusion

Our study concludes that Ponseti method under GA is an effective treatment and reduces the number of cast changes for neglected CTEV.

Data availability

Underlying data

Zenodo: Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus. https://doi.org/10.5281/zenodo.5939028²⁸

This project contains the following underlying data:

- Raw Data.sav (Raw cast change, Pirani data and age data)
- Raw Data.xlsx (Raw cast change, Pirani data and age data)

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

References

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Version 1

VERSION 1 PUBLISHED 29 Mar 2022

Author details Author details

¹ Orthopeadic and Traumatology Department, Brawijaya University, Malang, East Java, 65111, Indonesia

Panji Sananta
Roles: Conceptualization, Data Curation, Formal Analysis

Respati Suryanto Dradjat
Roles: Conceptualization, Supervision, Validation

Tofan Margaret Dwi Saputra
Roles: Investigation, Project Administration, Resources

Muhammad Alwy Sugiarto
Roles: Software, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 29 Mar 2022, 11:361

https://doi.org/10.12688/f1000research.109284.1

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© 2022 Sananta P et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Sananta P, Suryanto Dradjat R, Dwi Saputra TM and Sugiarto MA. Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus: a cohort study. [version 1; peer review: 3 not approved]. F1000Research 2022, 11:361 (https://doi.org/10.12688/f1000research.109284.1)

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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

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Reviewer Report 27 Jun 2022

Karthick Rangasamy, Department of Orthopaedics, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, Punjab and Haryana, India

Not Approved

https://doi.org/10.5256/f1000research.120767.r139315

First of all, I thank the F1000Research team for asking me to review this article on Neglected CTEV correction under GA by using the Ponseti method.

Although the authors presented their work in a reasonable way, there ... Continue reading

First of all, I thank the F1000Research team for asking me to review this article on Neglected CTEV correction under GA by using the Ponseti method.

Although the authors presented their work in a reasonable way, there are many concerns in this paper:

The age group of both the groups had a wide range from 2 to > 15 years, with the oldest being 24 years. The severity of the deformity also varies as the age advances and the child walks with a deformed foot. Although the Ponseti method of casting is the most common method of treatment to start the deformity correction even in old age and neglected cases too, I am not able to believe that the correction was achieved in 100% of cases in the GA group by casting alone without the need for any plantar fasciotomy, Achilles tenotomy or tendon lengthening, or minimal posteromedial soft tissue release surgeries in any of the cases in that group.
Assessment by Pirani scoring is good for kids less than one year of age. I may suggest Dimeglio scoring must be used for assessing the deformity before, during, and after the correction on older kids. The final outcome by means of functional assessment by using ICFSG score or Laaveg and Ponseti method may be more satisfying.
After the last cast removal, apart from exercises, is any foot orthosis (FAO) used to maintain correction?
The authors didn't mention any complications or reoccurrences obtained in their cohort. Maybe the follow-up is less, to assess the correct reoccurrence rates we need a long-term follow-up.
The risks involved in giving weekly general anesthesia to these children are debatable and the effect of these drugs on the brain development of these children needs to be studied.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Paediatric Orthopaedics, club foot

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report 27 Jun 2022

Manon Pigeolet, Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium

Not Approved

https://doi.org/10.5256/f1000research.120767.r139316

Thank you for offering me the opportunity to provide feedback on this work. I appreciate the research question a lot, and I think that the practical and technical difficulties that can arise during Ponseti casting in older children is a ... Continue reading

Thank you for offering me the opportunity to provide feedback on this work. I appreciate the research question a lot, and I think that the practical and technical difficulties that can arise during Ponseti casting in older children is a topic that has not received the attention it deserves in the literature. Casting an older child can be challenging, and whether outcomes are better when casting is done under GA is a valid question to be raised. It is also important to take the potential risks and side effects of GA into consideration.

However, I do have several points of concern that should be addressed before this study can be accepted for publication:

The use of Pirani scoring in older children is known to be less valuable. Also, in this context, solely measuring a decrease in Pirani feels like an artificial end-point. There are potentially more useful measurements that can be used to assess the value of using GA for casting: number of cast complications like pressure sores, pain experiences by children, number of casts needed to achieve a functional plantigrade foot or an operable foot in older children, number of casts needed to achieve a plantigrade foot (this data seems to have been collected but not fully addressed in the paper).
Table 1 and the results section are confusing as to how many patients and how many feet were included in the final analysis. The table shows that 16 children included in each group. While at the same time the table included 8 unilateral feet and 4 bilateral feet accounting for 12 children with 16 included feet for group A. So it is unclear to me whether there are 32 children in this study or 32 feet belonging to less than 32 children given that there are certain bilateral cases involved.
Having an age range of 2-24 years and only 32 feet/children involved constitutes a highly diverse group and it is unclear to me what the value is of drawing any conclusions on this set of cases. It is known that Ponseti treatment becomes less effective as a sole form of treatment in adolescents and young adults. This fact has been partially addressed by breaking down the groups into sub-groups by age. However, this approach creates such small sub-groups that the statistical relevance becomes negligible.
It is unclear as to why certain children were given GA and others weren't. Was there a specific reason why parents refused? A more detailed description of the decision making process of whether to do casting under GA or not would make the paper stronger.

In order for this paper to be acceptable for indexing I recommend the following to the authors:

I would kindly like to advise the authors to look into other assessment tools than the Pirani score as an outcome measure. Tools like the "Bangla clubfoot tool" for example lends itself well for use in an LMIC setting and with a population of older children. This tool assesses whether the foot is functional in daily life, and focuses less on anatomic landmarks and factors.
The authors should consider expanding the cohort to a larger number before resubmitting the paper. The authors should also consider limiting the age range of children included
In order to avoid bias from parental preference (or other influencing factors) regarding the usage of GA, a prospective randomized study should be considered by the authors

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

No

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Orthopedic surgery

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report 13 Jun 2022

Kelly Gray, Faculty of Medicine, Health and Human Sciences, Department of Health Professions, Macquarie University, Sydney, NSW, Australia

Not Approved

https://doi.org/10.5256/f1000research.120767.r139314

Thank you for the opportunity to review this study - it describes the use of oral GA to support the use of Ponseti casting in those with neglected clubfoot.

This is a challenging piece to review, because ... Continue reading

Thank you for the opportunity to review this study - it describes the use of oral GA to support the use of Ponseti casting in those with neglected clubfoot.

This is a challenging piece to review, because the use of general anaesthetics and potential side effects must be weighed against the benefits of the outcomes. With the information provided it is difficult to undertake a sound ethical analysis. Furthermore, there are study design considerations which are required to strengthen this work.

Firstly, the use of the Pirani score is challenging. While the Pirani score is widely used in the very young population, it is unable to provide the full picture of correction in an older population. The use of dorsiflexion and abduction, the Dimeglio Scale and/or QOL measured with a scale such as the Clubfoot DSI, can provide a clearer picture of the correction/function of the foot of the older child. While I can appreciate the difference in the Pirani score outcomes between the two groups, I am unable to determine whether the foot is functionally significantly better to justify the use of GA.

Secondly, a revision of the study design would increase confidence in results. Specifically:

Individuals would benefit from being matched in each group. This may be for severity, age, unilateral/bilateral and gender to allow comparability between groups. Group B had individuals with a Pirani score of 6 in 3/4 combined age groups, while the GA group had this in the >15 yr age group only. In the 11-15 year age group, Gp B had all participants with a Pirani of 4 while the GA group have individuals with a Pirani of 2 and 3.
The combining of unilateral and bilateral cases as individual feet can violate the assumption of independence. In bilateral cases, right and left feet may be affected by the same forces from the one individual - for example meaning that if one is less prone to correction, the other foot is likely to be the same. This violation can be overcome in a number of ways - statistical advice can support here.
The follow-up time of one month is unlikely to capture the potential for recurrence. While it may be assumed that a foot with better foot alignment is less likely to recur (or at least may take a longer period of time to recur) - this is challenging to definitively conclude within the follow-up period utilised.

Finally, the ethical argument of utilising GA for each cast change may be more justified in this case than others. Firstly, the use of regular oral GA needs to be weighed against the use of a single potentially more invasive GA for tenotomy. The authors noted that Group B required tenotomies - in centres this may be justified as a lesser risk than regular GA - however, in this setting this may be more justified and should be explored. Secondly, the argument to complete casting in a more timely manner may be justified in some settings. For example, Harnett et al. in 2011 justified the use of an accelerated Ponseti technique to reduce casting time in those from rural and remote settings for those who could not afford to be away from home or work for extended periods. The justification of completing casting faster to outweigh the risk of GA here requires further exploring.

Thank you again for the opportunity to review this paper. Further consideration of the outcome measures used, the study design and ethical justification for the use of GA in this setting would greatly improve this work.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Research expertise: congenital talipes equinovarus

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

CITE

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VERSION 1 PUBLISHED 29 Mar 2022

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Version 1 29 Mar 22	read	read	read

Kelly Gray, Macquarie University, Sydney, Australia
Manon Pigeolet, Université Libre de Bruxelles, Brussels, Belgium
Karthick Rangasamy, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India

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Reviewer Report

8 Views

27 Jun 2022 | for Version 1

Karthick Rangasamy, Department of Orthopaedics, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, Punjab and Haryana, India

8 Views Cite this report Responses(0)

Not Approved

First of all, I thank the F1000Research team for asking me to review this article on Neglected CTEV correction under GA by using the Ponseti method.

Although the authors presented their work in a reasonable way, there are many concerns in this paper:

The age group of both the groups had a wide range from 2 to > 15 years, with the oldest being 24 years. The severity of the deformity also varies as the age advances and the child walks with a deformed foot. Although the Ponseti method of casting is the most common method of treatment to start the deformity correction even in old age and neglected cases too, I am not able to believe that the correction was achieved in 100% of cases in the GA group by casting alone without the need for any plantar fasciotomy, Achilles tenotomy or tendon lengthening, or minimal posteromedial soft tissue release surgeries in any of the cases in that group.
Assessment by Pirani scoring is good for kids less than one year of age. I may suggest Dimeglio scoring must be used for assessing the deformity before, during, and after the correction on older kids. The final outcome by means of functional assessment by using ICFSG score or Laaveg and Ponseti method may be more satisfying.
After the last cast removal, apart from exercises, is any foot orthosis (FAO) used to maintain correction?
The authors didn't mention any complications or reoccurrences obtained in their cohort. Maybe the follow-up is less, to assess the correct reoccurrence rates we need a long-term follow-up.
The risks involved in giving weekly general anesthesia to these children are debatable and the effect of these drugs on the brain development of these children needs to be studied.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Paediatric Orthopaedics, club foot

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report

9 Views

27 Jun 2022 | for Version 1

Manon Pigeolet, Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium

9 Views Cite this report Responses(0)

Not Approved

Thank you for offering me the opportunity to provide feedback on this work. I appreciate the research question a lot, and I think that the practical and technical difficulties that can arise during Ponseti casting in older children is a topic that has not received the attention it deserves in the literature. Casting an older child can be challenging, and whether outcomes are better when casting is done under GA is a valid question to be raised. It is also important to take the potential risks and side effects of GA into consideration.

However, I do have several points of concern that should be addressed before this study can be accepted for publication:

The use of Pirani scoring in older children is known to be less valuable. Also, in this context, solely measuring a decrease in Pirani feels like an artificial end-point. There are potentially more useful measurements that can be used to assess the value of using GA for casting: number of cast complications like pressure sores, pain experiences by children, number of casts needed to achieve a functional plantigrade foot or an operable foot in older children, number of casts needed to achieve a plantigrade foot (this data seems to have been collected but not fully addressed in the paper).
Table 1 and the results section are confusing as to how many patients and how many feet were included in the final analysis. The table shows that 16 children included in each group. While at the same time the table included 8 unilateral feet and 4 bilateral feet accounting for 12 children with 16 included feet for group A. So it is unclear to me whether there are 32 children in this study or 32 feet belonging to less than 32 children given that there are certain bilateral cases involved.
Having an age range of 2-24 years and only 32 feet/children involved constitutes a highly diverse group and it is unclear to me what the value is of drawing any conclusions on this set of cases. It is known that Ponseti treatment becomes less effective as a sole form of treatment in adolescents and young adults. This fact has been partially addressed by breaking down the groups into sub-groups by age. However, this approach creates such small sub-groups that the statistical relevance becomes negligible.
It is unclear as to why certain children were given GA and others weren't. Was there a specific reason why parents refused? A more detailed description of the decision making process of whether to do casting under GA or not would make the paper stronger.

In order for this paper to be acceptable for indexing I recommend the following to the authors:

I would kindly like to advise the authors to look into other assessment tools than the Pirani score as an outcome measure. Tools like the "Bangla clubfoot tool" for example lends itself well for use in an LMIC setting and with a population of older children. This tool assesses whether the foot is functional in daily life, and focuses less on anatomic landmarks and factors.
The authors should consider expanding the cohort to a larger number before resubmitting the paper. The authors should also consider limiting the age range of children included
In order to avoid bias from parental preference (or other influencing factors) regarding the usage of GA, a prospective randomized study should be considered by the authors

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

No

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Orthopedic surgery

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

11 Views

13 Jun 2022 | for Version 1

Kelly Gray, Faculty of Medicine, Health and Human Sciences, Department of Health Professions, Macquarie University, Sydney, NSW, Australia

11 Views Cite this report Responses(0)

Not Approved

Thank you for the opportunity to review this study - it describes the use of oral GA to support the use of Ponseti casting in those with neglected clubfoot.

This is a challenging piece to review, because the use of general anaesthetics and potential side effects must be weighed against the benefits of the outcomes. With the information provided it is difficult to undertake a sound ethical analysis. Furthermore, there are study design considerations which are required to strengthen this work.

Firstly, the use of the Pirani score is challenging. While the Pirani score is widely used in the very young population, it is unable to provide the full picture of correction in an older population. The use of dorsiflexion and abduction, the Dimeglio Scale and/or QOL measured with a scale such as the Clubfoot DSI, can provide a clearer picture of the correction/function of the foot of the older child. While I can appreciate the difference in the Pirani score outcomes between the two groups, I am unable to determine whether the foot is functionally significantly better to justify the use of GA.

Secondly, a revision of the study design would increase confidence in results. Specifically:

Individuals would benefit from being matched in each group. This may be for severity, age, unilateral/bilateral and gender to allow comparability between groups. Group B had individuals with a Pirani score of 6 in 3/4 combined age groups, while the GA group had this in the >15 yr age group only. In the 11-15 year age group, Gp B had all participants with a Pirani of 4 while the GA group have individuals with a Pirani of 2 and 3.
The combining of unilateral and bilateral cases as individual feet can violate the assumption of independence. In bilateral cases, right and left feet may be affected by the same forces from the one individual - for example meaning that if one is less prone to correction, the other foot is likely to be the same. This violation can be overcome in a number of ways - statistical advice can support here.
The follow-up time of one month is unlikely to capture the potential for recurrence. While it may be assumed that a foot with better foot alignment is less likely to recur (or at least may take a longer period of time to recur) - this is challenging to definitively conclude within the follow-up period utilised.

Finally, the ethical argument of utilising GA for each cast change may be more justified in this case than others. Firstly, the use of regular oral GA needs to be weighed against the use of a single potentially more invasive GA for tenotomy. The authors noted that Group B required tenotomies - in centres this may be justified as a lesser risk than regular GA - however, in this setting this may be more justified and should be explored. Secondly, the argument to complete casting in a more timely manner may be justified in some settings. For example, Harnett et al. in 2011 justified the use of an accelerated Ponseti technique to reduce casting time in those from rural and remote settings for those who could not afford to be away from home or work for extended periods. The justification of completing casting faster to outweigh the risk of GA here requires further exploring.

Thank you again for the opportunity to review this paper. Further consideration of the outcome measures used, the study design and ethical justification for the use of GA in this setting would greatly improve this work.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Research expertise: congenital talipes equinovarus

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

Respond to this report

Responses (0)

[1] 1. Malhotra R, Mohapatra A, Arora G, et al.: Ponseti technique for the management of congenital talipes equinovarus in a rural set-up in india: Experience of 356 patients. Children. 2018; 5(4): 1–13. PubMed Abstract | Publisher Full Text

[2] 2. Dobbs MB, Rudzki JR, Purcell DB, et al.: Factors Predictive of Outcome after Use of the Ponseti Method for the Treatment of Idiopathic Clubfeet. J Bone Jt Surg - Ser A. 2004; 86(1): 22–27. PubMed Abstract | Publisher Full Text

[3] 3. Lynn Staheli M: Clubfoot: Ponseti Management [3rd Edition] - help_cfponseti.pdf.2009; 32. Reference Source

[4] 4. Maranho DAC, Volpon JB: Congenital clubfoot. Acta Ortopédica Bras. 2011; 19(3): 163–169. Publisher Full Text

[5] 5. Ganesan B, Luximon A, Al-Jumaily A, et al.: Ponseti method in the management of clubfoot under 2 years of age: A systematic review. PLoS One. 2017; 12(6): e0178299–e0178218. PubMed Abstract | Publisher Full Text

[6] 6. Penny JN: The neglected clubfoot. Tech Orthop. 2005; 20(2): 153–166. Publisher Full Text

[7] 7. Eidelman M, Kotlarsky P, Herzenberg JE: Treatment of relapsed, residual and neglected clubfoot: Adjunctive surgery. J Child Orthop. 2019; 13(3): 293–303. PubMed Abstract | Publisher Full Text

[8] 8. Alves C, Batlle AE, Rodriguez MV: Neglected clubfoot treated by serial casting: a narrative review on how possibility takes over disability. Ann Transl Med. 2021; 9(13): 1103–1103. PubMed Abstract | Publisher Full Text

[9] 9. Van Bosse HJP: Treatment of the Neglected and Relapsed Clubfoot. Clin Podiatr Med Surg. 2013; 30(4): 513–530. PubMed Abstract | Publisher Full Text

[10] 10. Haje DP: Neglected Idiopathic Clubfoot Successfully Treated by the Ponseti Method: A Case Report of an Adult Patient who Started Treatment at 26 Years of Age. J Orthop Case Rep. 2020; 10(4): 74–77. PubMed Abstract | Publisher Full Text

[11] 11. Rasit A, Azani H, Zabidah P, et al.: Clubfoot: The Treatment Outcome Using Quantitative Assessment of Deformity. Malaysian Orthop J. 2012; 6(4): 2–5. PubMed Abstract | Publisher Full Text

[12] 12. Lindahl O: Congenital clubfoot: Fundamentals oftreatment IGNACIO V. PONSETI. Sven läkartidningen. 1963; 60: 441–459.

[13] 13. Al-Mohrej OA, Alshaalan FN, Alhussainan TS: Is the modified Ponseti method effective in treating atypical and complex clubfoot? A systematic review. Int. Orthop. 2021; 45(10): 2589–2597. PubMed Abstract | Publisher Full Text

[14] 14. Jayasomeswar DN, Kumar DDM, Babu DBK: The outcome of Ponseti technique for idiopathic clubfoot. Int J Orthop Sci. 2019; 5(2): 774–777. Publisher Full Text

[15] 15. Ippolito E, Farsetti P, Caterini R, et al.: Long-term comparative results in patients with congenital clubfoot treated with two different protocols. J Bone Joint Surg Am. 2003; 85(7): 1286–1294. PubMed Abstract | Publisher Full Text

[16] 16. Hayes CB, Murr KA, Muchow RD, et al.: Pain and overcorrection in clubfeet treated by Ponseti method. J Pediatr Orthop Part B. 2018; 27(1): 52–55. PubMed Abstract | Publisher Full Text

[17] 17. Khan SA, Kumar A: Ponseti’s manipulation in neglected clubfoot in children more than 7 years of age: A prospective evaluation of 25 feet with long-term follow-up. J Pediatr Orthop Part B. 2010; 19(5): 385–389. PubMed Abstract | Publisher Full Text

[18] 18. Sheta RA, El-Sayed M: Is the Denis Browne Splint a Myth? A Long-Term Prospective Cohort Study in Clubfoot Management using Denis Browne Splint Versus Daily Exercise Protocol. J Foot Ankle Surg. 2020; 59(2): 314–322. PubMed Abstract | Publisher Full Text

[19] 19. Colburn M, Williams M: Evaluation of the treatment of idiopathic clubfoot by using the Ponseti method. J Foot Ankle Surg. 2003; 42(5): 259–267. Publisher Full Text

[20] 20. Saif Ullah M, Ferdous KMN, Shahjahan M, et al.: Management of Congenital Talipes Equino Varus (CTEV) by Ponseti Casting Technique in Neonates: Our Experience. J Neonatal Surg. 2013; 2(2): 17. PubMed Abstract | Publisher Full Text | Free Full Text

[21] 21. Hallaj-Moghaddam M, Moradi A, Ebrahimzadeh MH, et al.: Ponseti Casting for Severe Club Foot Deformity: Are Clinical Outcomes Promising?. Adv Orthop. 2015; 2015: 1–5. PubMed Abstract | Publisher Full Text

[22] 22. Pavone V, Testa G, Costarella L, et al.: Congenital idiopathic talipes equinovarus: an evaluation in infants treated by the Ponseti method. Eur Rev Med Pharmacol Sci. 2013; 17(19): 2675–2679. PubMed Abstract

[23] 23. Peterson N, Prior C: Correction of the Neglected Clubfoot in the Adolescent and Adult Patient. Foot Ankle Clin. 2020; 25(2): 205–220. PubMed Abstract | Publisher Full Text

[24] 24. Radler C: The Ponseti method for the treatment of congenital club foot: Review of the current literature and treatment recommendations. Int Orthop. 2013; 37(9): 1747–1753. PubMed Abstract | Publisher Full Text

[25] 25. Wu JP: Pediatric Anesthesia Concerns and Management for Orthopedic Procedures. Pediatr Clin N Am. 2020; 67(1): 71–84. PubMed Abstract | Publisher Full Text

[26] 26. Parada CSA, Baird GO, Auffant RA, et al.: Safety of percutaneous tendoachilles tenotomy performed under general anesthesia on infants with idiopathic clubfoot. J Pediatr Orthop. 2009; 29(8): 916–919. PubMed Abstract | Publisher Full Text

[27] 27. Alsuhebani M, Martin DP, Relland LM, et al.: Spinal anesthesia instead of general anesthesia for infants undergoing tendon Achilles lengthening. Local Reg Anesth. 2018; Volume 11: 25–29. PubMed Abstract | Publisher Full Text

[28] 28. Sananta P, Dradjat RS, Saputra TMD, et al.: Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus.Publisher Full Text

Ponseti method under general anesthesia is an effective method of treatment for neglected congenital talipes equino varus: a cohort study.

Abstract

Keywords

Introduction

Methods

Ethical considerations

Study design

Eligibility criteria

Outcome measures

Figure 1. Clinical picture before Ponseti cast with general anasthesia.

Figure 2. Clinical picture after Ponseti cast with general anasthesia.

Statistical analysis

Results

Description of patient

Table 1. Distribution of patients.

Pirani score with GA and without GA

Table 2. Difference Pirani score between using general anesthesia (GA) and without GA.

Discussion

Conclusion

Data availability

Underlying data

References

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