Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)

Unfo Ltd.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metatarsus Adductus Metatarsus Varus

Interventions

UNFO-sDEVICE

The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants

castPROCEDURE

casting of the infant legs

Eligibility

Sex: ALLMin age: 1 MonthMax age: 4 Months

Medical Language ↔ Plain English

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.

Locations (1)

Soroka MC

Beersheba, Israel

Outcomes

Primary Outcomes

Healing of the MTA

Healing of the MTA: straightening of the foot with apprx. 10% overcorrection

Time frame: 20 weeks

Secondary Outcomes

safety of the UNFO-s device

Safety is defined as absence of serious complications associated with the use of the investigational device within 2 month of the last visit.

Time frame: 7 months

Central Contacts

Dan Atar, Prof

CONTACT

972-506264277 dan_atar@yahoo.com

Data from ClinicalTrials.gov

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