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Sonication of Syndesmotic Screws

Sonication of Syndesmotic Screws

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03308617
Enrollment
90
Registered
2017-10-12
Start date
2017-04-01
Completion date
2020-06-01
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periimplant Infection

Keywords

sonication

Brief summary

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?

Detailed description

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.

Interventions

None listed

Sponsors

Jena University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients with syndesmotic screw removal after open reduction and internal fixation with plates and additional syndesmotic screw of ankle fractures (Weber B or C) in our department.

Exclusion criteria

* Patients with immunosuppressive diseases or therapies, * Pregnant women * Patients with pre-operations on the same ankle-joint * Patients with initial surgery for fracture fixation in other hospitals.

Design outcomes

Primary

MeasureTime frame
Detection rate of syndesmotic screw contamination using a sonication procedure compared to standard wound swabssix weeks

Secondary

MeasureTime frame
Clinical manifestation of infections by contaminated fracture fixation implantssix months

Countries

Germany

Contacts

Primary ContactMonique Kribus, Dr. med.
monique.kribus@med.uni-jena.de0049-3641-9322801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026