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

NCT07125794 | Recruiting

• 1 other identifier: HAH00072
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months post-procedure

Secondary Outcomes (2)

• Efficacy in maintaining correction measured by the Pirani score

  12 months post-procedure

• Incidence of complications

  12 months post-procedure

Study Arms (2)

Group I

Patients who were managed with the original Denis Browne splint.

Procedure: Original Denis Browne splint

Group II

Patients who were managed with the modified Denis Browne splint.

Procedure: Modified Denis Browne splint

Interventions

Original Denis Browne splint PROCEDURE

Patients who were managed with the original Denis Browne splint.

Group I

Modified Denis Browne splint PROCEDURE

Patients who were managed with the modified Denis Browne splint.

Group II

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will be carried out on 60 patients with idiopathic clubfoot after approval from the institutional ethical committee.

You may qualify if:

• Age from 2 to 5 years.
• Both sexes.
• Relapsed cases.
• Patients with idiopathic clubfoot.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The General Authority for Teaching Hospitals and Institutes: lead

Study Sites (1)

General Authority for Teaching Hospitals and Institutes

Cairo, Egypt

RECRUITING

Central Study Contacts

Mahmoud M Abdallah, MD

CONTACT

00201006194146; Mma-ortho@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgery

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 15, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)