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

Metatarsus Adductus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01600183
• Other study ID #: UNFO-12-SOR-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 14, 2012
• Last updated: May 15, 2012
• Start date: August 2012

Study information

• Verified date: May 2012
• Source: Unfo Ltd.
• Contact: Dan Atar, Prof
• Phone: 972-506264277
• Email: dan_atar[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 4 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metatarsus Adductus
• Metatarsus Varus

Intervention

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

Locations

Country	Name	City	State
Israel	Soroka MC	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Unfo Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of the MTA	Healing of the MTA: straightening of the foot with apprx. 10% overcorrection	20 weeks	No
Secondary	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.	7 months	Yes