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

NCT ID: NCT07125794

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-05-01

Brief Summary

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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

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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.

Conditions

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Denis Brawn Brace Modification Management Idiopathic Clubfoot Ponseti Casting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group I

Patients who were managed with the original Denis Browne splint.

Original Denis Browne splint

Intervention Type PROCEDURE

Patients who were managed with the original Denis Browne splint.

Group II

Patients who were managed with the modified Denis Browne splint.

Modified Denis Browne splint

Intervention Type PROCEDURE

Patients who were managed with the modified Denis Browne splint.

Interventions

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Original Denis Browne splint

Patients who were managed with the original Denis Browne splint.

Intervention Type PROCEDURE

Modified Denis Browne splint

Patients who were managed with the modified Denis Browne splint.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The General Authority for Teaching Hospitals and Institutes

NETWORK

Sponsor Role lead

Responsible Party

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Mahmoud Mohamed Abdallah

Orthopedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Authority for Teaching Hospitals and Institutes

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud M Abdallah, MD

Role: CONTACT

00201006194146

Facility Contacts

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Mahmoud M Abdallah, MD

Role: primary

00201006194146

Other Identifiers

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HAH00072

Identifier Type: -

Identifier Source: org_study_id

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