Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
PLN
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
1 other identifier
observational
33
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2007
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 29, 2008
CompletedFirst Posted
Study publicly available on registry
July 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJune 21, 2017
June 1, 2017
5.5 years
July 29, 2008
June 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
limb alignment
48 months
Secondary Outcomes (1)
length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications
48 Months
Study Arms (1)
1
The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children
Interventions
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
Eligibility Criteria
Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (3)
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic
Orlando, Florida, 32806, United States
Orthopedic Clinical Research
Charlotte, North Carolina, 28204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Russell Schenck, PhD
Zimmer Biomet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2008
First Posted
July 31, 2008
Study Start
November 1, 2007
Primary Completion
May 1, 2013
Study Completion
November 1, 2013
Last Updated
June 21, 2017
Record last verified: 2017-06