Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pediatric Locking Nail for the Treatment of Femoral Fractures in Children (PLN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00725894
First received: July 29, 2008
Last updated: November 15, 2013
Last verified: November 2013
  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: Observational Model: Cohort
Time Perspective: 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 ]

Enrollment: 33
Study Start Date: November 2007
Study Completion Date: November 2013
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
United States, Florida
Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic
Orlando, Florida, United States, 32806
United States, North Carolina
Orthopedic Clinical Research
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell Schenck, PhD Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00725894     History of Changes
Other Study ID Numbers: CS-010
Study First Received: July 29, 2008
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014