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| Sponsor: | EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing |
|---|---|
| Information provided by: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00725894 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Femur Fracture |
Device: Pediatric Locking Nail |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children
|
Device: Pediatric Locking Nail
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
|
Eligibility| Ages Eligible for Study: | 8 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred
Inclusion Criteria:
And any of the following fracture types
Exclusion Criteria:
Contacts and Locations| Contact: John Evangelista, MD | 973-299-9300 ext 3930 | john.evangelista@ebimed.com |
| United States, Arizona | |
| Phoenix Childrens Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Velva Woodward 602-546-1780 vwoodward@phoenixchildrens.com | |
| Principal Investigator: Lee Segal, MD | |
| United States, Florida | |
| Orlando Regional Hospital Pediatric Orthopedics | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Brenda Ecker 321-841-3040 brenda.ecker@orhs.org | |
| Contact: Kim Kimmell 321-841-3040 kim.kimmell@orhs.org | |
| Principal Investigator: Jonathan Phillips, MD | |
| Sub-Investigator: Mark Birnham, MD | |
| Sub-Investigator: Jay Albright, MD | |
| Sub-Investigator: Charles T Price, MD | |
| Sub-Investigator: Jose Herrera-Soto, MD | |
| Sub-Investigator: D. Raymond Knapp, MD | |
| United States, North Carolina | |
| Orthopedic Clinical Research | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Ada Mayfield 704-355-6943 ada.mayfield@carolinashealthcare.org | |
| Contact: Susan Ward 704-355-6943 susan.ward@carolinashealthcare.org | |
| Principal Investigator: Steven Frick, MD | |
| Sub-Investigator: J. Michael Wattenbarger, MD | |
| Sub-Investigator: Virginia F Casey, MD | |
| Sub-Investigator: D Christian Clark, MD | |
| Study Chair: | John Evangelista, MD | EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing |
More Information
| Responsible Party: | EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing ( Betsy Lowry, Supervisor Clinical Data, CRA ) |
| Study ID Numbers: | CS-010 |
| Study First Received: | July 29, 2008 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00725894 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Femoral Fractures Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries |