Systematic investigation and comparison of diagnostic modalities in implant associated infections and infected non unions

Not Applicable

Completed

• Conditions: M84.1; Nonunion of fracture [pseudarthrosis]

• Registration Number: DRKS00014014
• Lead Sponsor: BG Klinikum Duisburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Study Completion: 2021-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

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

Part II:
- osteomyelitis
- fistula, bare implants
- pregnancy
- malignant illness
- chronic inflammatory disease
- immuno-suppressive therapy
- i.v. drug abuse
- participation in other studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part I:<br>Descriptive statistics with determination of sensitiviy and specifity, 95%-confidence interval<br>Part II:<br>Verification of the superiority of the (filtration based) sonication compared to conventional cultures in terms of detecting low grade infections in non-unions.<br>

Secondary Outcome Measures

Name	Time	Method
Part II:<br>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.<br>2. Identification of the most sensitive diagnostic modality in terms of detecting low grade infections in non-unions.<br>3. Analysis of the bacteria entity and bacterial load in case of bacteria detection.<br>