Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

Femur Fracture Clinical Trial

— PLN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725894
• Other study ID #: CS-010
• Status: Completed
• Phase: N/A
• First received: July 29, 2008
• Last updated: June 19, 2017
• Start date: November 2007
• Est. completion date: November 2013

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Device:
• Pediatric Locking Nail
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.

Locations

Country	Name	City	State
United States	Orthopedic Clinical Research	Charlotte	North Carolina
United States	Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic	Orlando	Florida
United States	Phoenix Childrens Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	limb alignment		48 months
Secondary	length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications		48 Months