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

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.

Study Overview

• Status: Completed
• Conditions: Femur Fracture
• Intervention / Treatment: Device: Pediatric Locking Nail

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Childrens Hospital
  • Florida
    • Orlando, Florida, United States, 32806
      • Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Orthopedic Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
limb alignment	48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications	48 Months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Russell Schenck, PhD, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (Estimate): July 31, 2008

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: CS-010