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

NCT01600183 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Metatarsus Adductus
  • Metatarsus Varus

Interventions

DEVICE

UNFO-s

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

PROCEDURE

cast

casting of the infant legs

Sponsors & Collaborators

  • Unfo Ltd.

    lead INDUSTRY

Principal Investigators

  • Dan Atar, Prof · Soroka MC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600183 on ClinicalTrials.gov