M84.1
Conditions
Interventions
Group 1: Part I:
(Filtration based) sonication of sterilized titanium probes, which are inoculated with a defined amount of bacteria (Staph.epidermidis, DSM No. 3269). 10 series of probes are contamin
Sponsors
BG Klinikum Duisburg
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part II: - non-union at least 6 months after trauma (study group), respectively uneventful fracture consolidation (control group) - planned revision – independent of the study (study group), respectively scheduled implant removal – independent of the study (control group) - written consent
Exclusion criteria
Exclusion criteria: Part II: - osteomyelitis - fistula, bare implants - pregnancy - malignant illness - chronic inflammatory disease - immuno-suppressive therapy - i.v. drug abuse - participation in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: Descriptive statistics with determination of sensitiviy and specifity, 95%-confidence interval Part II: Verification of the superiority of the (filtration based) sonication compared to conventional cultures in terms of detecting low grade infections in non-unions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part II: 1. Verification of the non-inferiority of the (filtration based) sonication compared to alternative diagnostic modalities, e.g. conventional cultures, fluid cultures after tissue homogenization, in terms of detecting low grade infections in non-unions. 2. Identification of the most sensitive diagnostic modality in terms of detecting low grade infections in non-unions. 3. Analysis of the bacteria entity and bacterial load in case of bacteria detection. | — |
Countries
Germany
Contacts
Public ContactRobin;Eva Otchwemah;Steinhausen
Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie am Klinikum Köln-Merheim, Lehrstuhl der Universität Witten/ Herdecke;BG Klinikum Duisburg
Outcome results
None listed