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 be pain-free throughout life.
Treatment can be non-surgical, surgical or both. Non-surgical treatment (for example plaster casting or stretches) gently stretch the foot into a normal position. Surgery may involve the muscles, tendons, ligaments or joints.
From our searches we found 14 trials with 607 participants. All trials had problems of design or conduct that might have affected the results. Treatments were studied at birth (eight trials, 326 participants), during relapse (four trials, 181 participants) or at an unknown time (two trials, 100 participants).
Results and quality of the evidence
Our main measure of the success of treatment was function (how well the foot worked in everyday life). Only one trial reported on function; however, data were not available to re-analyse. We analysed data from three trials. When treated at birth, foot position was better after Ponseti plaster casting than after Kite plaster casting. The quality of this evidence was low. When treated at birth, foot position was better after Ponseti plaster casting than after a traditional technique (another type of plaster casting). The quality of this evidence was very low. One trial found Ponseti plaster casting three times per week to be as good as weekly Ponseti casting. This trial did not state at which stage the treatment was done. The quality of this evidence was moderate. Relapse following 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 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.
Further well-designed trials are needed to confirm these findings and to decide which is the best treatment for each presentation.
The searches for the review are up to date to April 2013.
From the limited evidence available, the Ponseti technique produced significantly better short-term foot alignment compared to the Kite technique and compared to a traditional technique. The quality of this evidence was low to very low. An accelerated Ponseti technique may be as effective as a standard technique, according to moderate quality evidence. 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 lack of available raw data. Future randomised controlled trials should address these issues.
Congenital talipes equinovarus (CTEV), which is 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. The review was first published in 2012 and we reviewed new searches in 2013 (update published 2014).
To evaluate the effectiveness of interventions for CTEV.
On 29 April 2013, we searched CENTRAL (2013, Issue 3 in The Cochrane Library), MEDLINE (January 1966 to April 2013), EMBASE (January 1980 to April 2013), CINAHL Plus (January 1937 to April 2013), AMED (1985 to April 2013), and the Physiotherapy Evidence Database (PEDro to April 2013). We also searched for ongoing trials in the WHO International Clinical Trials Registry Platform (2006 to July 2013) and ClinicalTrials.gov (to November 2013). We checked the references of included studies. We searched NHSEED, DARE and HTA for information for inclusion in the Discussion.
Randomised controlled trials (RCTs) and quasi-RCTs evaluating interventions for CTEV. Participants were people of all ages with CTEV of either one or both feet.
Two authors independently assessed risk 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.
We identified 14 trials in which there were 607 participants; one of the trials was newly included at this 2014 update. The use of different outcome measures prevented pooling of data for meta-analysis even when interventions and participants were comparable. All trials displayed bias in four or more areas. One trial reported on the primary outcome of function, though raw data were not available to be analysed. We were able to analyse data on foot alignment (Pirani score), a secondary outcome, from three trials. Two of the trials involved participants at initial presentation. One 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 (95% confidence interval (CI) 0.98 to 1.32) lower than that of the Kite group. The second trial found the Ponseti technique to be superior to a traditional technique, with average total Pirani scores of the Ponseti participants 1.50 lower (95% CI 0.72 to 2.28) after serial casting and Achilles tenotomy. A trial in which the type of presentation was not reported found no difference between an accelerated Ponseti or standard Ponseti treatment. At the end of serial casting, the average total Pirani scores in the standard group were 0.31 lower (95% CI -0.40 to 1.02) than the accelerated group. Two trials in initial cases found relapse following Ponseti treatment was more likely to be corrected with further serial casting compared to the Kite groups which more often required major surgery (risk difference 25% and 50%). There is a lack of evidence for different plaster casting products, the addition of botulinum toxin A during the Ponseti technique, different types of major foot surgery, continuous passive motion treatment following major foot surgery, or treatment of relapsed or neglected cases of CTEV. Most trials did not report on adverse events. 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.