Phase
Condition
Osteoporosis
Treatment
Fracture fixation via Intramedullary Nailing
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients 18 years or older.
Patient must have a signed EC approved informed consent.
Patient must have a monolateral or bilateral trochanteric, sub-trochanteric, orshaft fracture requiring surgical intervention or osteotomy and be eligible forfixation by intramedullary nailing.
Patient has been or is scheduled to be treated with the ZNN Bactiguard SystemCephalomedullary Nail.
Patient must be able and willing to complete the protocol required follow-up.
Patients capable of understanding the surgeon's explanations and following hisinstructions.
Exclusion
Exclusion Criteria:
Skeletally immature patients
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, subject with alcohol/drugaddiction, known to be pregnant or breastfeeding).
Patient anticipated to be non-compliant and/or likely to have problems complyingwith the follow-up program (e.g. patient with no fixed address, long-distance, plansto move during course of study).
Study Design
Study Description
Connect with a study center
Centre Hospitalier de Douai
Douai, 59507
FranceSite Not Available
Hospital Rio Hortega
Valladolid, Castilla-La Mancha 47012
SpainActive - Recruiting
Hospital Clinico de Valencia
Valencia, 46010
SpainActive - Recruiting
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