About this trial
This study aims to compare the effectiveness of the original Denis Brawn brace to its modification in managing relapsed idiopathic clubfoot in patients following Ponseti casting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 2 to 5 years.
Both sexes.
Relapsed cases.
Patients with idiopathic clubfoot.
Disqualifiers
Neurological or syndromic involvement.
Presenting with skin or soft-tissue lesions around the foot and ankle.
Inadequate documentation.
Soft-tissue surgery is needed (except tendo-achilles tenotomy).
Trial population
This retrospective study will be carried out on 60 patients with idiopathic clubfoot after approval from the institutional ethical committee.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Original Denis Browne splint
Procedure/SurgeryPatients who were managed with the original Denis Browne splint.
Modified Denis Browne splint
Procedure/SurgeryPatients who were managed with the modified Denis Browne splint.
Treatment groups
Trial outcomes
Primary outcomes
Parents' compliance
Parents' compliance will be classified into three grades as follows: * Grade 0: poor follow-up with a lack of commitment in bracing hours (bad compliance). * Grade 1: an intermittent follow-up with a good commitment in bracing hours (intermediate compliance). * Grade 2: a good follow-up with a strict commitment in bracing hours (good compliance).
Secondary outcomes
Efficacy in maintaining correction measured by the Pirani score
The Pirani scoring system is reliable, quick, and easy to use, and provides a good forecast about the likely treatment for an individual foot. It involves evaluating six clinical signs of contracture, with scores ranging from 0 to 1 for each sign, and a higher score indicating a more severe deformity. All the patients treated will undergo thorough evaluation to find out other systemic diseases, and grading of the feet as per the modified Pirani scoring system.
Incidence of complications
Incidence of complications will be recorded.
Sponsors and contacts
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