Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

Completed

Conditions studied: Femur Fracture

In brief

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.

Key facts

Study ID

NCT00725894

Run by

Zimmer Biomet

People needed

33

Starts

2007-11-01

Expected to finish

2013-11-01

Last updated by the study team

2017-06-21

Who can join

Age: 8 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic — Orlando, Florida, United States
• Orthopedic Clinical Research — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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