Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Original Denis Browne splint, Modified Denis Browne splint.
- Who it may be relevant to
- Registry conditions: Denis Brawn Brace, Modification, Management, Idiopathic Clubfoot. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.
Overview
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.
Detailed description
Clubfoot is an intricate deformity of the ankle and foot involving bony malalignment, adduction of the forefoot, and hindfoot varus, cavus, and equinus caused by contracture of soft tissues.
Lack of compliance causes the majority of relapse, as the child may have problems sleeping and wearing the Dennis Brown Splint; that is why parental counseling is vital and very much important in this regard.
Bracing plays a vital role in the maintenance of corrected club foot and allows the foot to achieve normal position after tenotomy, followed by serial casting. Bracing holds the foot not in a corrected but in an overcorrected position so that the normal position of the foot could be achieved after the correction. Without bracing, it is almost impossible for the physician or the surgeon to maintain the correction.
Interventions
- Procedure Original Denis Browne splint
Patients who were managed with the original Denis Browne splint. - Procedure Modified Denis Browne splint
Patients who were managed with the modified Denis Browne splint.
Primary outcome measures
- Parents' compliance [Time frame: 12 months post-procedure]
Secondary outcome measures (2)
- Efficacy in maintaining correction measured by the Pirani score [Time frame: 12 months post-procedure]
- Incidence of complications [Time frame: 12 months post-procedure]
Eligibility criteria
Inclusion criteria
- Age from 2 to 5 years.
- Both sexes.
- Relapsed cases.
- Patients with idiopathic clubfoot.
Exclusion criteria
- 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).
- Irregular plaster casting schedule.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- General Authority for Teaching Hospitals and Institutes — Cairo
Identifiers
NCT: NCT07125794 · HAH00072