Phase
Condition
N/ATreatment
ZNN Bactiguard Retrograde Femoral Nail
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must be 18 years or older.
Patient must have a femoral fracture (open, closed, monolateral or bilateral)requiring surgical intervention and be eligible for fixation by intramedullarynailing. Patients with delayed treatment (initial treatment by external fixation dueto swelling / high energy trauma followed by definitive treatment by intramedullarynail) can also be included.
Patient has been or is scheduled to be treated with the ZNN Bactiguard SystemRetrograde Femoral Nail.
Patient must be able and willing to complete the protocol required follow-up.
Patient must have a signed EC approved consent.
Patients capable of understanding the surgeon's explanations and following hisinstructions.
Exclusion
Exclusion Criteria:
Skeletally immature patients
A medullary canal obliterated by a previous fracture or tumor
Bone shaft having excessive bow or a deformity
Lack of bone substance or bone quality, which makes stable seating of the implantimpossible
All concomitant diseases that can impair the operation, functioning or the successof the implant
Insufficient blood circulation
Infection
Patient is unwilling or unable to give consent.
Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand what participation to the study entails, alcohol/drug addiction, known tobe pregnant or breast feeding).
Patient anticipated to be non-compliant and/or likely to have problems withmaintaining follow-up program (e.g. patient with no fixed address, long distance,plans to move during course of study).
Not expected to survive the duration of the follow-up program
Study Design
Study Description
Connect with a study center
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz De Tenerife, Tenerife 38010
SpainSite Not Available
Leeds General Infirmary
Leeds, LS1 3EX
United KingdomActive - Recruiting
Manchester Royal Infirmary
Manchester,
United KingdomActive - Recruiting
Stepping Hill Hospital
Stockport,
United KingdomSite Not Available
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