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Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting

The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07125794
Enrollment
60
Registered
2025-08-15
Start date
2025-05-01
Completion date
2026-05-01
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Denis Brawn Brace, Idiopathic Clubfoot, Management, Modification, Ponseti Casting

Brief summary

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

PROCEDUREOriginal Denis Browne splint

Patients who were managed with the original Denis Browne splint.

PROCEDUREModified Denis Browne splint

Patients who were managed with the modified Denis Browne splint.

Sponsors

The General Authority for Teaching Hospitals and Institutes
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Parents' compliance12 months post-procedureParents' 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

MeasureTime frameDescription
Efficacy in maintaining correction measured by the Pirani score12 months post-procedureThe 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 complications12 months post-procedureIncidence of complications will be recorded.

Countries

Egypt

Contacts

Primary ContactMahmoud M Abdallah, MD
Mma-ortho@hotmail.com00201006194146

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026