JBI Collaborating Centre
Centre for Allied Health Evidence (CAHE)
University of South Australia
City East Campus
Centre for Allied Health Evidence
University of South Australia, Adelaide
Contact for review
Name: Dr. Saravana Kumar
Email: [email protected]
Name: Janine Margarita R. Dizon
Email: [email protected]
Name: Lucylynn Lizarando
Email: [email protected]
30th of September 2008
Expected completion date
31st of March 2009
Background and rationale for assessment
“Club foot”, also known as Congenital Talipes Equino Varus (CTEV), is a common congenital deformity of the foot. CTEV has an estimated birth prevalence of 1 per 1,000 live births with approximately half presentations bilateral in nature (1). CTEV results in an equine deformity characterised by ankle plantar flexion, subtalar inversion and adduction of the hind and forefoot. The foot itself is usually short and broad in appearance. The muscles of the lower leg are often smaller in diameter and do not fully develop. The incidence among different races ranges from 0.39 per 1000 among the Chinese population to 1.2 per 1000 among Caucasian to 6.8 per 1000 among Polynesians (2). Lochmiller 1998 recently reported a male-to-female ration of 2.5:1. and that 24.4% of affected individual have a family history of idiopathic talipes equino varus (3).
CTEV can be further classified into structural and postural. Structural CTEV is associated with genetic deformities such as neurological conditions (Edward's syndrome, Spina bifida, arthrogryposis and Cerebral Palsy) and connective tissue disorders (Larsen's Syndrome, diastrophic dwarfism). The deformity in these presentations are often more severe and require early surgical intervention. Postural CTEV on the other hand is thought to be the result of external influences which include increased intrauterine pressure and breach births and responds to both surgical and conservative procedures.
Over the last ten years, the treatment of this complex deformity has raised the interest of many health care professionals (especially physiotherapists and paediatric medical professionals). The treatment of CTEV can be challenging and when poorly treated, can result in ongoing disability and pain. Poor treatment can lead to secondary bone changes causing further deformity in the developing child.
Each presentation is different and generally management begins right after diagnosis. Intervention options are determined by child's age, overall health, medical history and severity of the presentation. The child's tolerance and parental preference are also influencing factors. Generally the aim of intervention is to correct the positional deformity and re-align the foot in an anatomically neutral position. There is a general consensus that initial treatment should begin with a conservative approach (4) before surgery is considered. The basic principles of conservative management are based on gentle manipulations followed by serial castings and bracing. The most common method is the Ponseti technique. This involves a gradual correction of the condition through passive mobilizations and a series of casting for about five to seven weeks. Achilles tenotomy may be performed before the last cast is applied and finally a brace is worn 23 hours a day for a period of up to three to four months (5,6). Another conservative management is the Kite technique which uses a forceful manipulation over a wooden wedge and a Thomas wrench. (7). The Kite technique corrects the each component of the deformity separately instead of simultaneously. Therefore, it takes months and several cast changes to slowly correct the condition and people have opted for other procedures (2).
Surgical approaches are also considered for CTEV. Surgery, however, is delayed until the child has reached six months. During surgery, soft tissue releases for tendons and ligaments, osteotomies and arthrodeses, and tendon transfers may be undertaken. Typically, corrections are held in place with surgical wires and/or pins and are later removed, approximately four to six weeks after surgery. However, as with any surgery there are associated risks of infection, adverse reactions to anesthetic and excessive bleeding. Post surgery, there are risks of vasular insufficency, infection, stiffness and excessive scarring as well as pain (8) For these reasons, the non surgical management has gained popularity amongst parents of children with CTEV, who prefer the conservative technique over the surgical approach (5).
It is in this context that we aim to establish the best available evidence for the effectiveness of the most common conservative intervention (Ponseti method) in the management of CTEV, which leads us to the objective of this review.
- The general objective of this study is to assess the effectiveness of Ponseti method in the management of congenital talipes equino varus (club foot)
- What is the evidence of effectiveness of the Ponseti method versus other conservative treatments in the management of congenital talipes equinovarus (club foot)?
Criteria for considering studies for this review
Types of studies
To determine evidence of the effectiveness of Ponseti method versus other conservative treatments in the management of congenital talipes equinovarus, randomized controlled clinical trials (RCTs) are the study design of choice. Clinical controlled trials (CCTs) and quasi experimental trials will be considered in the absence of RCTs.
Types of participants
This review will include any study using the Ponseti method to children 0-2 years old with idiopathic clubfoot born full term. Children with co-existing pathologies and those who underwent surgical procedures prior to commencing of Ponseti treatment will be excluded.
Types of interventions
The Ponseti method is a very well defined technique involving a number of manipulations and serial application of casts which gradually corrects plantar flexion of the ankle, inversion of the heel and the adduction of the hind and forefoot. This review will consider studies that include the Ponseti technique as an intervention.
Correction of the position of the foot measured by: range of motion, time required for correction (weeks), number of relapses, number of children sent for extensive surgery.
Search strategy for identification of studies
Both published and unpublished English language studies will be sought. Assessment for inclusion of foreign language publications will be based on the English language extract, and if considered appropriate, an English translation of the study will be sought.
Bibliographic databases and Key words
The following keywords will be used to search for studies to be included in this review
Databases will be searched for all the years available as indicated below. Studies identified during the database searches will be assessed for relevance from a review of the title, abstract and descriptors of the study. A full text report will be obtained for all studies deemed to be relevant. The databases that will be searched include:
In order to minimize publication bias, unpublished studies will also be identified using Dissertations Abstracts International and Proceedings First.
The reference lists of all identified publications (both included and excluded), will be searched for additional studies. Hand searching of relevant conference proceedings will also be included.
Content experts will be contacted in order to obtain additional references, unpublished trials and ongoing trials.
Methods of the review
The evidence of the retrieved studies will be assessed using the JBI levels of evidence (Table 1)
Assessment of methodological quality
Two independent reviewers will critically appraise each study. A third reviewer will be consulted if there is disagreement between reviewers. The ‘JBI Critical Appraisal of Evidence Effectiveness’ will be used to critically appraise each study (Appendix 1). The JBI tool consists of eleven items, each requiring a dichotomous yes/no response, with a yes response being allocated one point, and a no/unclear response being allocated zero points. Studies scoring six or above on the JBI critical appraisal tool will be categorized as good quality.
Data will be extracted independently by two reviewers using the ‘JBI data extraction tool’ (Appendix 2). A third reviewer (Dr. Saravana Kumar) will be asked to adjudicate if the initial reviewers disagree. Data to be collected will include type of design; details of randomisation (if used), study population, intervention, control, outcomes, and quality and result of study analysis. When necessary, we will attempt to contact the researchers of a study to obtain missing information.
Data will be summarised statistically if they are sufficiently similar and if they are of adequate quality. If two or more studies are comparable in terms of extract dose and formulation, patient demographics, and disease activity, data will be pooled in meta-analysis using Review Manager (Revman) software. Weighted mean differences and 95% confidence intervals (CI) will be calculated for continuous data to analyse the size of the effects of the interventions. For dichotomous data, the effect sizes will be expressed in terms of relative risks and 95% CI.
Statistical heterogeneity between trials will be assessed using chi-square analysis. In the presence of significant heterogeneity (p < 0.05), a random effects meta-analysis will be used. Causes of heterogeneity will be explored by conducting subgroup and sensitivity analyses. If the statistical pooling of results is inappropriate, the findings will be summarised in narrative form.
For tracking purposes, all articles obtained for the review will be recorded on a data storage form (Appendix 3), which will provide details about the article's authors, title and source, which database the article was retrieved from, and the location where the article is being stored.
Potential conflict of interest
1. Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of Ponseti method for treatment of idiopathic clubfeet. J Bone Joint Surg [Am] 2004;86-A(1):22-27.
2. Cummings JR, Davidson RS, Armstrong PF, Lehman, W. Congenital clubfoot. J Bone Joint Surg [Am] 2002;84(2):290-308.
3. Lochmiller C, Johnston D, Scott A, Risman M, Hecht J. Genetic Epidemiology study of idiopathic talipes equinovarus. Am J Med Genet 1998;79:90-96.
4. Morcuende JA, Dolan LA, Dietz FR, Ponseti, I.V. Radical reduction in the rate of extensive corrective surgery for clubfoot using Ponseti method. Pediatrics 2004;113:376-380.
5. Ponseti IV. Congenital clubfoot: fundamentals of treatment. Oxford: Oxford University press; 1996.
6. Judd J. Congenital Talipes Equino-Varus: Evidence for using the Ponseti Method of Treatment. J Orthop Nurs 2004;8:160-163.
7. Kite JH. Non operative treatment of congenital clubfeet: A Review of one hundred cases. Southern Medical Journal 1930; 23(4):337
8. Docker C, Lewthwaite S, Kiely N. Ponseti treatment in the management of clubfoot deformity-a continuing role for paediatric orthopaedic services in secondary care centres. Ann R Coll Surg Engl 2007;89:510-512.
APPENDIX 1 JBI Critical appraisal of evidence of effectiveness
APPENDIX 2 JBI Data extraction sheet
APPENDIX 3 Data Storage Form