Detection of infected fracture non-unions with contrast enhanced ultrasound (CEUS), magnetic resonance imaging (DCE-MRI) and sonication - a prospective study

Recruiting

• Conditions: M84.1; M96.0; Nonunion of fracture [pseudarthrosis]; Pseudarthrosis after fusion or arthrodesis

• Registration Number: DRKS00011484
• Lead Sponsor: Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM) e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients with non-union fractures with suspected infection

Exclusion Criteria

- known intolerance for SonoVue
- severe heart failure (NYHA III/IV)
- myocardial infarction within the last 14 days
- severe respiratory diseases
- pregnancy and breastfeeding
- age under 18 years
- contraindication for DCE-MRI

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of infection-associated hyperperfusion with contrast-enhanced ultrasound and MRI during the week before surgery and sonication of the explant within 6 hours after explantation

Secondary Outcome Measures

Name	Time	Method
psychosocial outcome: SF-12; pain: visual analog scale prior to surgery, 12 weeks, 6 months, 12 months after surgery