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The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric Locking Nail | Device | The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| limb alignment | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications | 48 Months |
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Inclusion Criteria:
And any of the following fracture types
Exclusion Criteria:
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Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred
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| Name | Affiliation | Role |
|---|---|---|
| Russell Schenck, PhD | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States | ||
| Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Orlando |
| Florida |
| 32806 |
| United States |
| Orthopedic Clinical Research | Charlotte | North Carolina | 28204 | United States |