M84.1 M96.0
Conditions
Interventions
Group 1: CEUS (Contrast-enhanced ultrasound) and DCE MRI (dynamic contrast-enhanced MRI) in patients with a non-union and positive result of microbiological testing of non-union tissue samples acquire
Sponsors
Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM) e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patient with non-union and indication for surgical treatment
Exclusion criteria
Exclusion criteria: - congenital pseudarthrosis - severe heart failure (NYHA III/IV) - myocardial infarction within the last 14 days - severe respiratory diseases - pregnancy and breastfeeding - known intolerance for SonoVue - Missing informed consent form - contraindication for DCE-MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic quality of preoperative hyperperfusion in CEUS (Contrast-enhanced ultrasound) / DCE-MRI (dynamic contrast-enhanced MRI) for the detection of infected non-unions. A prospective study-design including preoperative and 12-week-followup CEUS examinations as well as preoperative and 12-week, 6-months, and 12 months-followup DCE-MRI examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Psychosocial evaluation: SF-12, preoperatively as well as 12 weeks, 6 months and 12 months postoperatively - Pain: Visual analog scale, preoperatively as well as 12 weeks, 6 months and 12 months postoperatively | — |
Countries
Germany
Contacts
Public ContactChristian Alexander Fischer
Universität Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
Outcome results
None listed