Status:
COMPLETED
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
Lead Sponsor:
Zimmer Biomet
Conditions:
Femur Fracture
Eligibility:
All Genders
8-16 years
Brief 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.
Eligibility Criteria
Inclusion
- Subject, representative willing to sign informed consent.
- Ability and willingness of the subject to follow postoperative care instructions until healing is complete
- Subject age must be between 8-16 inclusive.
- Subjects with a minimal canal diameter of 9mm or greater
- And any of the following fracture types
- Non-comminuted and comminuted mid-shaft fractures
- Distal third fractures 4 cm above the distal physis
- Fractures that are open or closed
- Subtrochanteric fractures
Exclusion
- A subject has a bone or soft tissue infection.
- Subject has a systemic infection.
- Subject has a distal (supracondylar) fracture.
- Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
- Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
- Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00725894
Start Date
November 1 2007
End Date
November 1 2013
Last Update
June 21 2017
Active Locations (3)
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1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
2
Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic
Orlando, Florida, United States, 32806
3
Orthopedic Clinical Research
Charlotte, North Carolina, United States, 28204