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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UNKNOWN
90 participants
OBSERVATIONAL
2017-04-01
2020-06-01
Brief Summary
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On the author hand, contamination of implants without clinical signs of infection is reported in up to 30% during implant removals after uneventful fracture healing. The raised general questions are: 1.) Is a positive microbiological finding the result of contamination during the index surgery or during implant removal? 2.) Does contaminated implants without clinical or serological signs of infection have a pathological value?
Detailed Description
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Patients with ankle fractures (Weber B and C) treated operatively in our department by open reduction and internal fixation with plates and additional syndesmotic screw should be included. After patients´ informed consent, several microbiological samples should be taken for further microbiological analysis during the standard syndesmotic screw removal 6-8 weeks after the index surgery. At follow up of two weeks after screw removal a clinical examination and serological analysis for infection will be performed. The endpoint of study is fracture healing at six months.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
* Patients with pre-operations on the same ankle-joint
* Patients with initial surgery for fracture fixation in other hospitals.
18 Years
ALL
No
Sponsors
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Jena University Hospital
OTHER
Responsible Party
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Principal Investigators
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Florian Gras, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Trauma-, Hand- and Reconstructive Surgery
Locations
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Department of Trauma-, Hand- and Reconstructive Surgery
Jena, Thuringia, Germany
Countries
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Central Contacts
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Facility Contacts
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Florian Gras, PD Dr. med.
Role: primary
Other Identifiers
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JenaUC
Identifier Type: -
Identifier Source: org_study_id