Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
NCT ID: NCT01600183
Last Updated: 2012-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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casting
subjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit.
cast
casting of the infant legs
UNFO-s
subjects with MTA will be treated with the UNFO-s device for 12 weeks - will be worn day and night during first 6 weeks and only at night during next 6 weeks
UNFO-s
The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants
Interventions
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UNFO-s
The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants
cast
casting of the infant legs
Eligibility Criteria
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Inclusion Criteria
* Consenting parents
* Ages 1-4 months
Exclusion Criteria
* Neuromuscular disorders
* Any condition which in the opinion of the investigator renders the subject ineligible for study participation.
1 Month
4 Months
ALL
No
Sponsors
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Unfo Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Atar, Prof
Role: PRINCIPAL_INVESTIGATOR
Soroka MC
Locations
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Soroka MC
Beersheba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UNFO-12-SOR-CTIL
Identifier Type: -
Identifier Source: org_study_id
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