Metatarsus Adductus, Metatarsus Varus
Conditions
Keywords
MTA, metatarsus, Metatarsus Adductus, also known as Metatarsus Varus
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.
Interventions
DEVICEUNFO-s
The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants
PROCEDUREcast
casting of the infant legs
Sponsors
Unfo Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 4 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of the MTA | 20 weeks | Healing of the MTA: straightening of the foot with apprx. 10% overcorrection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of the UNFO-s device | 7 months | Safety is defined as absence of serious complications associated with the use of the investigational device within 2 month of the last visit. |
Countries
Israel
Contacts
Primary ContactDan Atar, Prof
Outcome results
None listed