Back to resultsSafety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
Primary Purpose
Metatarsus Adductus, Metatarsus Varus
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
UNFO-s
cast
Sponsored by
About this trial
This is an interventional treatment trial for Metatarsus Adductus focused on measuring MTA, metatarsus, Metatarsus Adductus, also known as Metatarsus Varus
Eligibility Criteria
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.
Sites / Locations
- Soroka MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
casting
UNFO-s
Arm Description
subjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit.
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
Outcomes
Primary Outcome Measures
Healing of the MTA
Healing of the MTA: straightening of the foot with apprx. 10% overcorrection
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01600183
Brief Title
Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
Official Title
Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unfo Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsus Adductus, Metatarsus Varus
Keywords
MTA, metatarsus, Metatarsus Adductus, also known as Metatarsus Varus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
casting
Arm Type
Active Comparator
Arm Description
subjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit.
Arm Title
UNFO-s
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
UNFO-s
Intervention Description
The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants
Intervention Type
Procedure
Intervention Name(s)
cast
Intervention Description
casting of the infant legs
Primary Outcome Measure Information:
Title
Healing of the MTA
Description
Healing of the MTA: straightening of the foot with apprx. 10% overcorrection
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
safety of the UNFO-s device
Description
Safety is defined as absence of serious complications associated with the use of the investigational device within 2 month of the last visit.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Atar, Prof
Phone
972-506264277
Email
dan_atar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Atar, Prof
Organizational Affiliation
Soroka MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka MC
City
Beer Sheva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Atar, Prof
Phone
972-50-6264277
Email
dan_atar@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
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