Periimplant Infection Clinical Trial
Official title:
Sonication of Syndesmotic Screws
Peri-implant infections are severe complications after internal fracture fixation surgery.
Detection of causative agents of orthopedic implant-associated infections (OIAI) is
demanding. Several authors reported increased identification rates of bacterial prevalence
using different sonication procedures compared to standard tissue cultures samples,
especially for low grade infections.
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?
In this prospective case study, the detection rates of different diagnostic tools for
peri-implant contaminations during removal of syndesmotic screws should be compared and the
clinical consequence of positive findings evaluated in follow up investigations up to 6
months.
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.
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