Original Denis Browne brace versus modified Denis Browne brace for relapsed idiopathic clubfoot after Ponseti casting
Official title: The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.
Run by The General Authority for Teaching Hospitals and Institutes · NCT07125794 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 2 Years to 5 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The General Authority for Teaching Hospitals and Institutes Research network |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT07125794 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.