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

Zimmer Biomet3 sites in 1 country33 target enrollmentNovember 2007

ConditionsFemur Fracture

Overview

Phase: N/A
Intervention: Not specified
Conditions: Femur Fracture
Sponsor: Zimmer Biomet
Enrollment: 33
Locations: 3
Primary Endpoint: limb alignment
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

November 2013

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject, representative willing to sign informed consent.
•Ability and willingness of the subject to follow postoperative care instructions until healing is complete
•Subject age must be between 8-16 inclusive.
•Subjects with a minimal canal diameter of 9mm or greater
•And any of the following fracture types
•Non-comminuted and comminuted mid-shaft fractures
•Distal third fractures 4 cm above the distal physis
•Fractures that are open or closed
•Subtrochanteric fractures

Exclusion Criteria

•A subject has a bone or soft tissue infection.
•Subject has a systemic infection.
•Subject has a distal (supracondylar) fracture.
•Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
•Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
•Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
•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.