Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725894
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Femur Fracture Device: Pediatric Locking Nail

Layout table for study information
Study Type : Observational
Actual Enrollment : 33 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. limb alignment [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications [ Time Frame: 48 Months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725894

Layout table for location information
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
Zimmer Biomet
Layout table for investigator information
Study Director: Russell Schenck, PhD Zimmer Biomet

Layout table for additonal information
Responsible Party: Zimmer Biomet Identifier: NCT00725894     History of Changes
Other Study ID Numbers: CS-010
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries