The purpose of this review was to assess treatments for congenital talipes equinovarus (clubfoot).
Clubfoot is a condition, present at birth, in which the foot is in an inturned position. There is no known cause. 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). Treatment aims to put the foot back into a normal position and to be pain-free throughout life.
Treatment can be non-surgical, surgical or both. Non-surgical treatment (for example, casting or stretches) gently stretches the foot into a normal position. Surgery may involve the muscles, tendons, ligaments or joints. Kite and Ponseti techniques both involve prolonged joint manipulation and serial casting to correct foot alignment. The Ponseti technique involves manipulation (of the ankle joint) and usually Achilles tendon surgery, while Kite is a technique involving manipulation of the foot.
From our searches we found 21 trials with 905 participants. All trials had problems of design or conduct that might have affected the results. Treatments were studied at birth (14 trials, 560 participants), during relapse (four trials, 181 participants), or at an unknown time (three trials, 153 participants). We required studies to have used 'validated' measures (i.e. shown to be reliable, consistent, and sensitive to change). Many trials did not take bilateral cases (children with two affected feet) into account during randomisation and statistical analysis. For these reasons, we were unable to include much of the data from the trials in the review.
Results and certainty of the evidence
Our main measure of the success of treatment was function (how well the foot worked in everyday life). Two trials reported on function but data were not available to re-analyse.
Three trials that compared Ponseti with other casting techniques in children treated at birth provided data that we could analyse on foot alignment. One found that foot position may be better after Ponseti plaster casting than after Kite plaster casting. In the second trial, the evidence was uncertain whether foot position was better after Ponseti plaster casting than after a traditional technique (another type of plaster casting). One trial found that weekly Ponseti casting may be as good as Ponseti plaster casting three times a week (accelerated Ponseti). This trial did not state at which stage the treatment was done. A third trial found that the Ponseti technique may have similar results when using plaster of Paris or semi-rigid fibreglass.
No trial assessed the quality of walking using a validated assessment. Two trials reported on the primary outcome of function using validated scales, but raw data were not available for analysis and the trials did not provide quality-of-life data that were suitable for reporting in the review.
We found no trials in relapsed or neglected clubfoot.
A trial in which the type of presentation was not reported found that there may be no important difference between an accelerated Ponseti or standard Ponseti treatment in foot alignment.
Relapse following the Kite technique more often required major surgery than relapse following the Ponseti technique. Data were not available to assess the results for adding botulinum toxin A, which temporarily weakens injected muscles, to the Ponseti treatment, using different types of plaster casts in the Ponseti treatment, different foot surgeries, or the treatment of relapsed or neglected clubfoot. Most trials did not report on harmful effects. When reported, harmful effects during plaster casting included casts slipping, plaster sores, and skin irritation. Harmful effects of infection and skin grafting were reported after surgery.
The searches for the review are up to date to May 2019.
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.
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.
To assess the effects of any intervention for any type of CTEV in people of any age.
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.
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.
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,
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.