Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

Completed

• Conditions: Femur Fracture
• Interventions: Device: Pediatric Locking Nail

• Registration Number: NCT00725894
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-07-31
• Primary Completion: 2013-05
• Study Completion: 2013-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Pediatric Locking Nail	The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children

Primary Outcome Measures

Name	Time	Method
limb alignment	48 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic; 🇺🇸 Orlando, Florida, United States

Orthopedic Clinical Research; 🇺🇸 Charlotte, North Carolina, United States

Phoenix Childrens Hospital; 🇺🇸 Phoenix, Arizona, United States