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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011484

Enrollment

Registered

2017-01-02

Start date

2017-01-10

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

M84.1 M96.0

Interventions

Group 1: Patients with non-unions and diagnosed infection via sonication, i.e. detection of bacterial growth in microbiological analysis following sonication of explanted material Group 2: Patients w

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients with non-union fractures with suspected infection

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactChristian Alexander Fischer

Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie

christian.fischer@med.uni-heidelberg.de062215635366

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026