NCT01600183

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

May 14, 2012

Last Update Submit

May 15, 2012

Conditions

Metatarsus AdductusMetatarsus Varus

Keywords

MTAmetatarsusMetatarsus Adductus, also known as Metatarsus Varus

Outcome Measures

Primary Outcomes (1)

  • Healing of the MTA

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

    20 weeks

Secondary Outcomes (1)

  • safety of the UNFO-s device

    7 months

Study Arms (2)

casting

ACTIVE COMPARATOR

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

Procedure: cast

UNFO-s

EXPERIMENTAL

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

Device: UNFO-s

Interventions

UNFO-sDEVICE

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

UNFO-s
castPROCEDURE

casting of the infant legs

casting

Eligibility Criteria

Age1 Month - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects with an acute MTA that did not receive any treatment for this condition
  • Consenting parents
  • Ages 1-4 months

You may not qualify if:

  • Participation in another clinical trial.
  • Neuromuscular disorders
  • Any condition which in the opinion of the investigator renders the subject ineligible for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka MC

Beersheba, Israel

Location

MeSH Terms

Conditions

Metatarsus Varus

Interventions

POLR1G protein, human

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Dan Atar, Prof

    Soroka MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Atar, Prof

CONTACT

972-506264277dan_atar@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

IL(1)