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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| casting | Active Comparator | subjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNFO-s | Device | The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing of the MTA | Healing of the MTA: straightening of the foot with apprx. 10% overcorrection | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Atar, Prof | Contact | 972-506264277 | dan_atar@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Atar, Prof | Soroka MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka MC | Beersheba | Israel |
|
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| ID | Term |
|---|---|
| D000070592 | Metatarsus Varus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C119975 | POLR1G protein, human |
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| cast | Procedure | casting of the infant legs |
|