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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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This is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard casting or using the UNFO-s device for total time of 20 weeks.

Detailed Description

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Conditions

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Metatarsus Adductus Metatarsus Varus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

cast

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

UNFO-s

Intervention Type DEVICE

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

Intervention Type DEVICE

cast

casting of the infant legs

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects with an acute MTA that did not receive any treatment for this condition
* Consenting parents
* Ages 1-4 months

Exclusion Criteria

* Participation in another clinical trial.
* Neuromuscular disorders
* Any condition which in the opinion of the investigator renders the subject ineligible for study participation.
Minimum Eligible Age

1 Month

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unfo Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Atar, Prof

Role: PRINCIPAL_INVESTIGATOR

Soroka MC

Locations

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Soroka MC

Beersheba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Dan Atar, Prof

Role: CONTACT

972-506264277

Facility Contacts

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Dan Atar, Prof

Role: primary

972-50-6264277

Other Identifiers

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UNFO-12-SOR-CTIL

Identifier Type: -

Identifier Source: org_study_id

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