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

Zimmer Biomet

Status: Completed

Conditions: Femur Fracture

Treatments: Device: Pediatric Locking Nail

Study type: Observational

Funder types: Industry

Identifiers

NCT00725894

CS-010

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

33 participants in 1 patient group

1

Description:

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

Treatment:

Device: Pediatric Locking Nail