Sonication of Syndesmotic Screws

Periimplant Infection Clinical Trial

Official title:

Sonication of Syndesmotic Screws

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03308617
• Other study ID #: JenaUC
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2017
• Last updated: October 11, 2017
• Start date: April 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2017
• Source: Jena University Hospital
• Contact: Monique Kribus, Dr. med.
• Phone: 0049-3641-9322801
• Email: monique.kribus[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periimplant Infection

Locations

Country	Name	City	State
Germany	Department of Trauma-, Hand- and Reconstructive Surgery	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of syndesmotic screw contamination using a sonication procedure compared to standard wound swabs		six weeks
Secondary	Clinical manifestation of infections by contaminated fracture fixation implants		six months