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

Unfo Ltd.

Status: Unknown

Conditions: Metatarsus Adductus; Metatarsus Varus

Treatments: Procedure: cast; Device: UNFO-s

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600183

UNFO-12-SOR-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 4 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

casting

Active Comparator group

Description:

subjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit.

Treatment:

Procedure: cast

UNFO-s

Experimental group

Description:

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

Treatment:

Device: UNFO-s