CompletedNot Applicable

Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

United States33 participantsStarted 2007-11

Plain-language 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.

Who can participate

Age range8 Years – 16 Years

SexALL

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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
✓. 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.

What they're measuring

limb alignment

Timeframe: 48 months

Trial details

NCT IDNCT00725894

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Femur Fracture trials