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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-5
SponsorThe General Authority for Teaching Hospitals and Institutes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 2 to 5 years.

Both sexes.

Relapsed cases.

Patients with idiopathic clubfoot.

Disqualifiers

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).

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Original Denis Browne splint

    Procedure/Surgery

    Patients who were managed with the original Denis Browne splint.

  • Modified Denis Browne splint

    Procedure/Surgery

    Patients who were managed with the modified Denis Browne splint.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group I1 intervention
Group B: Group II1 intervention

Trial outcomes

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).

Time frame
12 months post-procedure

Secondary outcomes

1

Efficacy in maintaining correction measured by the Pirani score

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.

Time frame
12 months post-procedure
2

Incidence of complications

Incidence of complications will be recorded.

Time frame
12 months post-procedure

Other outcomes

Sponsors and contacts

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