Denis Brawn BraceNCT07125794
Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting
An observational study of Denis Brawn Brace and Modification, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Denis Brawn Brace, Modification, Management
- What is being tested?
- Original Denis Browne splint and Modified Denis Browne splint
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: This retrospective study will be carried out on 60 patients with idiopathic clubfoot after approval from the institutional ethical committee.
Who may be able to join
- Age from 2 to 5 years.
- Both sexes.
- Relapsed cases.
- Patients with idiopathic clubfoot.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
General Authority for Teaching Hospitals and Institutes
Cairo
Mahmoud M Abdallah, MD, 00201006194146, Mma-ortho@hotmail.com
About this study
Official title: The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.
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.
Read the detailed 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.
- Being tested
- Original Denis Browne splint, Modified Denis Browne splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original Denis Browne splintProcedure or surgery
Patients who were managed with the original Denis Browne splint.
Modified Denis Browne splintProcedure or surgery
Patients who were managed with the modified Denis Browne splint.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients who were managed with the original Denis Browne splint. Receives: Procedure: Original Denis Browne splint | |
| Group II | Patients who were managed with the modified Denis Browne splint. Receives: Procedure: Modified Denis Browne splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post-procedure
Secondary outcomes (2)
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.
Measured: 12 months post-procedure
Incidence of complications
Incidence of complications will be recorded.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denis Brawn BraceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Mahmoud Mohamed Abdallah, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125794
- Sponsor's protocol ID
- HAH00072
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT07125794
- Acronym / sponsor ID
- HAH00072
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Original Denis Browne splintPatients who were managed with the original Denis Browne splint. |
| Group II | – | Procedure: Modified Denis Browne splintPatients who were managed with the modified Denis Browne splint. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This retrospective study will be carried out on 60 patients with idiopathic clubfoot after approval from the institutional ethical committee.
Key inclusion criteria (4 listed)
- Age from 2 to 5 years.
- Both sexes.
- Relapsed cases.
- Patients with idiopathic clubfoot.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Original Denis Browne splintPatients who were managed with the original Denis Browne splint. | Procedure or surgery | Group I |
| Modified Denis Browne splintPatients who were managed with the modified Denis Browne splint. | Procedure or surgery | Group II |
Primary outcome
Parents' compliance
Time frame: 12 months post-procedure
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).
2 secondary outcomes
Efficacy in maintaining correction measured by the Pirani score
Time frame: 12 months post-procedure
Incidence of complications
Time frame: 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Denis Brawn Brace and Modification, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud M Abdallah, MD (00201006194146, Mma-ortho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' compliance (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.