Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00725894

Acronym

PLN

Enrollment

Registered

2008-07-31

Start date

2007-11-30

Completion date

2013-11-30

Last updated

2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture

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.

Interventions

DEVICEPediatric Locking Nail

The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 16 Years

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.

Design outcomes

Primary

Measure	Time frame
limb alignment	48 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026