UnknownNot Applicable

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

Israel50 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range1 Month – 4 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Healing of the MTA

Timeframe: 20 weeks

Trial details

NCT IDNCT01600183

SponsorUnfo Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

Contact for this trial

Dan Atar, Prof

972-506264277 dan_atar@yahoo.com

View on ClinicalTrials.gov More Metatarsus Adductus trials