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. 2020 May 15;5(5):CD008602.
doi: 10.1002/14651858.CD008602.pub4.

Interventions for congenital talipes equinovarus (clubfoot)

Affiliations

Interventions for congenital talipes equinovarus (clubfoot)

Shadi Bina et al. Cochrane Database Syst Rev. .

Abstract

Background: Congenital talipes equinovarus (CTEV), also known as clubfoot, is a common congenital orthopaedic condition characterised by an excessively turned-in foot (equinovarus) and high medial longitudinal arch (cavus). If left untreated it can result in long-term disability, deformity and pain. Interventions can be conservative (such as splinting or stretching) or surgical. Different treatments might be effective at different stages: at birth (initial presentation); when initial treatment does not work (resistant presentation); when the initial treatment works but the clubfoot returns (relapse/recurrent presentation); and when there has been no early treatment (neglected presentation). This is an update of a review first published in 2010 and last updated in 2014.

Objectives: To assess the effects of any intervention for any type of CTEV in people of any age.

Search methods: On 28 May 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL Plus, AMED and Physiotherapy Evidence Database. We also searched for ongoing trials in the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov (to May 2019). We checked the references of included studies.

Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs evaluating interventions for CTEV, including interventions compared to other interventions, sham intervention or no intervention. Participants were people of all ages with CTEV of either one or both feet.

Data collection and analysis: Two review authors independently assessed the risks of bias in included trials and extracted the data. We contacted authors of included trials for missing information. We collected adverse event information from trials when it was available. When required we attempted to obtain individual patient data (IPD) from trial authors for re-analysis. If unit-of-analysis issues were present and IPD unavailable we did not report summary data, MAIN RESULTS: We identified 21 trials with 905 participants; seven trials were newly included for this update. Fourteen trials assessed initial cases of CTEV (560 participants), four trials assessed resistant cases (181 participants) and three trials assessed cases of unknown timing (153 participants). The use of different outcome measures prevented pooling of data for meta-analysis, even when interventions and participants were comparable. All trials displayed high or unclear risks of bias in three or more domains. Twenty trials provided data. Two trials reported on the primary outcome of function using a validated scale, but the data were not suitable for inclusion because of unit-of-analysis issues, as raw data were not available for re-analysis. We were able to analyse data on foot alignment (Pirani score), a secondary outcome, from three trials in participants at initial presentation. The Pirani score is a scale ranging from zero to six, where a higher score indicates a more severe foot. At initial presentation, one trial reported that the Ponseti technique significantly improved foot alignment compared to the Kite technique. After 10 weeks of serial casting, the average total Pirani score of the Ponseti group was 1.15 points lower than that of the Kite group (mean difference (MD) -1.15, 95% confidence interval (CI) -1.32 to -0.98; 60 feet; low-certainty evidence). A second trial found the Ponseti technique to be superior to a traditional technique, with mean total Pirani scores of the Ponseti participants 1.50 points lower than after serial casting and Achilles tenotomy (MD -1.50, 95% CI -2.28 to -0.72; 28 participants; very low-certainty evidence). One trial found evidence that there may be no difference between casting materials in the Ponseti technique, with semi-rigid fibreglass producing average total Pirani scores 0.46 points higher than plaster of Paris at the end of serial casting (95% CI -0.07 to 0.99; 30 participants; low-certainty evidence). We found no trials in relapsed or neglected cases of CTEV. A trial in which the type of presentation was not reported showed no evidence of a difference between an accelerated Ponseti and a standard Ponseti treatment in foot alignment. At the end of serial casting, the average total Pirani score in the accelerated group was 0.31 points higher than the standard group (95% CI -0.40 to 1.02; 40 participants; low-certainty evidence). No trial assessed gait using a validated assessment. Health-related quality of life was reported in some trials but data were not available for re-analysis. There is a lack of evidence for the addition of botulinum toxin A during the Ponseti technique, different types of major foot surgery or continuous passive motion treatment following major foot surgery. Most trials did not report on adverse events. Two trials found that further serial casting was more likely to correct relapse after Ponseti treatment than after the Kite technique, which more often required major surgery (risk differences 25% and 50%). In trials evaluating serial casting techniques, adverse events included cast slippage (needing replacement), plaster sores (pressure areas), and skin irritation. Adverse events following surgical procedures included infection and the need for skin grafting.

Authors' conclusions: From the evidence available, the Ponseti technique may produce significantly better short-term foot alignment compared to the Kite technique. The certainty of evidence is too low for us to draw conclusions about the Ponseti technique compared to a traditional technique. An accelerated Ponseti technique may be as effective as a standard technique, but results are based on a single small comparative trial. When using the Ponseti technique semi-rigid fibreglass casting may be as effective as plaster of Paris. Relapse following the Kite technique more often led to major surgery compared to relapse following the Ponseti technique. We could draw no conclusions from other included trials because of the limited use of validated outcome measures and the unavailability of raw data. Future RCTs should address these issues.

PubMed Disclaimer

Conflict of interest statement

SB: none known.

VP: has received consultancy fees, research grants and conference financial support for various activities unrelated to this study.

EHB: none known.

JB: Joshua Burns' research and clinical activities are funded by the Australian Department of Health (Medical Research Future Fund), US National Institutes of Health, Charcot‐Marie Tooth Association of Australia, Charcot‐Marie Tooth Association (USA), Diabetes Australia, Elizabeth Lottie May Rosenthal Bone Bequest, Perpetual Limited, Humpty Dumpty Foundation. Consultancies: Acceleron Pharma (Sept 2016).

KG: none known.

Figures

1
1
Flow diagram illustrating the study selection process.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study. Green = low risk of bias; yellow = unclear risk of bias; red = high risk of bias.
3
3
Forest plot of comparison: 1 Kite versus Ponseti technique for treatment of initial CTEV. Pirani score after 10 weeks of serial casting.
4
4
Forest plot of comparison: 2 Ponseti versus traditional treatment (plaster casting and surgery) for treatment of initial CTEV. Pirani score at end of initial Ponseti (serial plaster casting and tenotomy) and traditional treatment (serial plaster casting only).
5
5
Forest plot of comparison: 4 Comparison of plaster of paris and semi rigid casting at initial presentation, outcome: 4.1 Pirani score at end of casting in those awaiting tenotomy.
6
6
Forest plot of comparison: 3 Accelerated Ponseti technique versus standard Ponseti technique at unknown intervention timepoint, outcome: 3.1 Foot alignment: Pirani score at the end of serial plaster casting.
1.1
1.1. Analysis
Comparison 1: Ponseti versus Kite technique for treatment of initial CTEV, Outcome 1: Foot alignment: Pirani score at 10 weeks
2.1
2.1. Analysis
Comparison 2: Ponseti versus traditional treatment (plaster casting and surgery) for treatment of initial CTEV, Outcome 1: Foot alignment: Pirani score at end of serial plaster casting
3.1
3.1. Analysis
Comparison 3: Ponseti technique. Comparison of semi‐rigid fibreglass and plaster of Paris., Outcome 1: Foot alignment: Pirani score at end of casting in those awaiting tenotomy
4.1
4.1. Analysis
Comparison 4: Accelerated Ponseti technique versus standard Ponseti technique, Outcome 1: Foot alignment: Pirani score at the end of serial plaster casting

Update of

References

References to studies included in this review

Chen 2015 {published data only}
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Narang 2011 {published data only}
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Nilgün 2011 {published data only}
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Ponseti 2006 {published data only}
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Richards 2008 {published data only}
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References to ongoing studies

Madhuri 2018 {published data only}
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NCT03249805 {unpublished data only}
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References to other published versions of this review

Gray 2010
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Gray 2014
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