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Clinical evaluation of an original orthosis to prevent clubfoot recurrence idiopathic congenital treated with the Ponseti method

Grant number: 21/03264-5
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Effective date (Start): June 01, 2021
Effective date (End): May 31, 2022
Field of knowledge:Health Sciences - Medicine
Principal Investigator:José Batista Volpon
Grantee:Fábio David da Silva
Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil


Background: Idiopathic clubfoot is the most common congenital deformity of the feet. It should be treated early in the newborn with manipulations and successive plastered immobilizations, followed by percutaneous tenotomy of the tendon of Achilles (Ponseti Method). Then, there is a need to use an orthosis to decrease the recurrence rate. Classically, Denis Browne's orthosis is recommended to be used for 23 hours a day until ambulation, and night use after the start of the march, until the age of four. However, adherence to this type of orthosis is very low, due to the rejection of the child, who usually removes the orthosis at night, and parental withdrawal. The orthosis in question uses two orthopedic boots connected by a metal bar, which causes discomfort, great restriction of movement, and prevents the crawl. As a result, some suropodalic orthoses have been developed to replace the Denis-Browne orthosis. However, there are still doubts as to its efficiency and what is the ideal model. However, this type of orthosis has the advantage of being used only on the affected limb, and let the lower limbs free from each other, which, theoretically, it would increase treatment adherence. Based on existing orthoses we developed a new model with special supports, simpler, lighter, and less bulky, and causes less discomfort to the child. This orthosis has already been used in a pilot group of patients with encouraging results. However, in the literature, we found comparative studies of new orthosis models with the classic Denis Browne. Objective: to compare the performance of the orthosis developed by us in relation to the Denis-Browne orthosis, regarding the ability to maintain correction and adherence to treatment. Material and methods: clinical trial, randomized and simple-blind, where after the correction of the deformity by the Ponseti technique it will be applied randomly the classic orthosis, or the one developed by us. A total of 139 feet were randomized and intended for treatment with one of these orthoses; the children with bilateral involvement will use the same orthosis on each of the feet, separately. The subjects were initially followed up every two months until they were one year old and every three months until the end of the fourth year. Epidemiological data will be obtained and the maintenance of the correction will be assessed by the Pirani scale, questionnaires, and radiographs. Family adherence to treatment will also be assessed by the incidence of abandonment the use of the orthosis. (AU)

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