Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-10-23
2027-12-31
Brief Summary
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Detailed Description
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The primary endpoint is the assessment of performance by analyzing fracture healing.
The secondary endpoints are the assessment of safety, clinical benefit and post-op fracture related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ZNN Bactiguard Retrograde Femoral Nail
Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture.
ZNN Bactiguard Retrograde Femoral Nail
Femoral fracture internal fixation.
Interventions
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ZNN Bactiguard Retrograde Femoral Nail
Femoral fracture internal fixation.
Eligibility Criteria
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Inclusion Criteria
* Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
* Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde 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 his instructions.
Exclusion Criteria
* 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 implant impossible
* All concomitant diseases that can impair the operation, functioning or the success of the implant
* Insufficient blood circulation
* Infection
* Patient is unwilling or unable to give consent.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding).
* Patient anticipated to be non-compliant and/or likely to have problems with maintaining 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
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Locations
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Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Leeds General Infirmary
Leeds, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CME2021-40T
Identifier Type: -
Identifier Source: org_study_id