Status:
UNKNOWN
MiracleFeet Foot Abduction Brace Sensor Trial
Lead Sponsor:
MiracleFeet
Collaborating Sponsors:
Bai Jerbai Wadia Hospital for Children, Mumbai, India
Metwiz Materials
Conditions:
Clubfoot
Telemedicine
Eligibility:
All Genders
3-1 years
Phase:
NA
Brief Summary
The aim of this study is to determine the effect of a new design of FAB type on compliance and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little literature exists on...
Detailed Description
Clubfoot is the most common birth defect affecting 1 in every 750 live births, that is about 200,000 babies each year globally (80% mainly in developing countries). An estimated average 1 million chil...
Eligibility Criteria
Inclusion
- Unilateral or bilateral cases of idiopathic clubfoot in children who have not yet started walking at first presentation, receiving a brace for the first time after successful correction with the Ponseti method of treatment, at the Bai Jerbai Wadia Hospital for Children over a period of 6 months.
Exclusion
- All children who are already walking at presentation; All children with previous treatment; All children who have used FAB previously; All children treated with surgery other than tenotomy; All children with syndromic or neuropathic cases of clubfoot; All children with atypical clubfoot.
Key Trial Info
Start Date :
June 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03249805
Start Date
June 7 2017
End Date
December 31 2018
Last Update
August 17 2018
Active Locations (1)
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1
Bai Jerbai Wadia Hospital for Children
Mumbai, Maharashtra, India, 400012