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Pediatric Locking Nail for the Treatment of Femoral Fractures in Children (PLN)
This study is currently recruiting participants.
Verified by Biomet, Inc., February 2010
First Received: July 29, 2008   Last Updated: February 2, 2010   History of Changes
Sponsor: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Information provided by: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00725894
  Purpose

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.


Condition Intervention
Femur Fracture
Device: Pediatric Locking Nail

Study Type: Observational
Study Design: Cohort, Prospective
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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • limb alignment [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children
Device: Pediatric Locking Nail
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725894

Contacts
Contact: John Evangelista, MD 973-299-9300 ext 3930 john.evangelista@ebimed.com

Locations
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Velva Woodward     602-546-1780     vwoodward@phoenixchildrens.com    
Principal Investigator: Lee Segal, MD            
United States, Florida
Orlando Regional Hospital Pediatric Orthopedics Recruiting
Orlando, Florida, United States, 32806
Contact: Brenda Ecker     321-841-3040     brenda.ecker@orhs.org    
Contact: Kim Kimmell     321-841-3040     kim.kimmell@orhs.org    
Principal Investigator: Jonathan Phillips, MD            
Sub-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            
United States, North Carolina
Orthopedic Clinical Research Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Ada Mayfield     704-355-6943     ada.mayfield@carolinashealthcare.org    
Contact: Susan Ward     704-355-6943     susan.ward@carolinashealthcare.org    
Principal Investigator: Steven Frick, MD            
Sub-Investigator: J. Michael Wattenbarger, MD            
Sub-Investigator: Virginia F Casey, MD            
Sub-Investigator: D Christian Clark, MD            
Sponsors and Collaborators
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Investigators
Study Chair: John Evangelista, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

No publications provided

Responsible Party: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing ( Betsy Lowry, Supervisor Clinical Data, CRA )
Study ID Numbers: CS-010
Study First Received: July 29, 2008
Last Updated: February 2, 2010
ClinicalTrials.gov Identifier: NCT00725894     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on February 08, 2010