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NCT Number: NCT07125794

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

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.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Authority for Teaching Hospitals and Institutes

Cairo, Egypt

Location status: Recruiting

Location contact

Mahmoud M Abdallah, MD

CONTACT

[email protected]

00201006194146

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Original Denis Browne splint

Procedure

Patients who were managed with the original Denis Browne splint.

Modified Denis Browne splint

Procedure

Patients who were managed with the modified Denis Browne splint.

Primary outcomes

  1. Parents' compliance

    Time frame: 12 months post-procedure

    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

  1. Efficacy in maintaining correction measured by the Pirani score

    Time frame: 12 months post-procedure

    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.

  2. Incidence of complications

    Time frame: 12 months post-procedure

    Incidence of complications will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud M Abdallah, MD

CONTACT

[email protected]

00201006194146

Sponsors and collaborators

Lead sponsor

The General Authority for Teaching Hospitals and Institutes

Network

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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