Original Denis Browne brace versus modified Denis Browne brace for relapsed idiopathic clubfoot after Ponseti casting
The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.
This project tests whether a modified Denis Browne brace works better than the original Denis Browne brace for 2- to 5-year-old children with relapsed idiopathic clubfoot after Ponseti casting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | The General Authority for Teaching Hospitals and Institutes Research network |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07125794 on ClinicalTrials.gov |
What this trial studies
This observational comparison enrolls children aged 2–5 years who have relapsed idiopathic clubfoot after Ponseti casting and assigns them to use either the original Denis Browne brace or a modified Denis Browne brace. Researchers will follow patients over time to monitor recurrence, compliance with bracing, and any skin or soft-tissue problems. Outcomes will be compared between groups to see if the modification changes relapse rates or improves tolerability. Standard exclusions include syndromic/neurologic cases, active skin lesions, need for additional soft-tissue surgery (other than tendo‑achilles tenotomy), and inadequate prior casting documentation.
Who should consider this trial
Good fit: Children aged 2 to 5 years with relapsed idiopathic clubfoot after Ponseti casting who do not have neurological or syndromic involvement and who can adhere to a bracing schedule are ideal candidates.
Not a fit: Children with syndromic or neurologic clubfoot, active skin or soft-tissue lesions around the foot and ankle, those requiring additional soft-tissue surgery beyond tendo‑achilles tenotomy, or with inadequate prior casting documentation are unlikely to benefit from the bracing comparison.
Why it matters
Potential benefit: If successful, the modified brace could reduce relapse rates and improve comfort and compliance, lowering the need for repeat casting or further surgery.
How similar studies have performed: Bracing with the Denis Browne splint is an established method to prevent relapse after Ponseti correction, but direct comparative evidence on specific brace modifications is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- General Authority for Teaching Hospitals and Institutes — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud M Abdallah, MD
- Email: Mma-ortho@hotmail.com
- Phone: 00201006194146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.