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

The General Authority for Teaching Hospitals and Institutes

Status: Enrolling

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

Treatments: Procedure: Modified Denis Browne splint; Procedure: Original Denis Browne splint

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07125794

HAH00072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Group I

Description:

Patients who were managed with the original Denis Browne splint.

Treatment:

Procedure: Original Denis Browne splint

Group II

Description:

Patients who were managed with the modified Denis Browne splint.

Treatment:

Procedure: Modified Denis Browne splint