Sonication of Syndesmotic Screws

October 11, 2017 updated by: Jena University Hospital

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?

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thüringen
      • Jena, Thüringen, Germany, 07740
        • Recruiting
        • Department of Trauma-, Hand- and Reconstructive Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with operatively treated ankle fractures.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate of syndesmotic screw contamination using a sonication procedure compared to standard wound swabs
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical manifestation of infections by contaminated fracture fixation implants
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Investigators

  • Principal Investigator: Florian Gras, PD Dr. med., Department of Trauma-, Hand- and Reconstructive Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JenaUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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