Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
NCT ID: NCT00725894
Last Updated: 2017-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2007-11-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children
Pediatric Locking Nail
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
Interventions
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Pediatric Locking Nail
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
Eligibility Criteria
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Inclusion Criteria
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
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.
8 Years
16 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Russell Schenck, PhD
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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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
Countries
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Other Identifiers
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CS-010
Identifier Type: -
Identifier Source: org_study_id
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