Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Femur Fracture
Intervention: Pediatric Locking Nail (Device)
Phase: N/A
Status: Recruiting
Sponsored by: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing Official(s) and/or principal investigator(s):
John Evangelista, MD, Study Chair, Affiliation: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Overall contact:
John Evangelista, MD, Phone: 973-299-9300, Ext: 3930, Email: john.evangelista@ebimed.com
Summary
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.
Clinical Details
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
Study design: Cohort, Prospective
Primary outcome: limb alignment
Secondary outcome: length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications
Eligibility
Minimum age: 8 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subject, representative willing to sign informed consent.
2. Ability and willingness of the subject to follow postoperative care instructions
until healing is complete
3. Subject age must be between 8-16 inclusive.
4. Subjects with a minimal canal diameter of 9mm or greater
And any of the following fracture types
1. Non-comminuted and comminuted mid-shaft fractures
2. Distal third fractures 4 cm above the distal physis
3. Fractures that are open or closed
4. Subtrochanteric fractures
Exclusion Criteria:
1. A subject has a bone or soft tissue infection.
2. Subject has a systemic infection.
3. Subject has a distal (supracondylar) fracture.
4. Subject with pathological bone (osteogenesis imperfecta and other conditions
resulting in abnormal bone quality).
5. Subjects with mental or neurological condition who are unwilling or incapable of
following postoperative care instructions.
6. Subject with conditions including blood supply limitation, and insufficient quantity
or quality of bone.
7. Foreign body sensitivity, where material sensitivity is suspected, testing is to be
completed prior to implantation of device if at all practical or the subject should
be excluded.
Locations and Contacts
John Evangelista, MD, Phone: 973-299-9300, Ext: 3930, Email: john.evangelista@ebimed.com
Orlando Regional Hospital Pediatric Orthopedics, Orlando, Florida 32806, United States; Recruiting
Brenda Ecker, Phone: 321-841-3040, Email: brenda.ecker@orhs.org
Kim Kimmell, Phone: 321-841-3040, Email: kim.kimmell@orhs.org
Jonathan Phillips, MD, Principal 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, Sub-Investigator
Orthopedic Clinical Research, Charlotte, North Carolina 28204, United States; Recruiting
Ada Mayfield, Phone: 704-355-6943, Email: ada.mayfield@carolinashealthcare.org
Susan Ward, Phone: 704-355-6943, Email: susan.ward@carolinashealthcare.org
Steven Frick, MD, Principal Investigator
J. Michael Wattenbarger, MD, Sub-Investigator
Virginia F Casey, MD, Sub-Investigator
D Christian Clark, MD, Sub-Investigator
Additional Information
Starting date: November 2007
Ending date: December 2013
Last updated: June 26, 2009
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