Advanced Microperfusion Assessed Non-union Diagnostics with Ultrasound

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

• Registration Number: DRKS00012833
• Lead Sponsor: Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM) e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Study Completion: 2020-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Patient with non-union and indication for surgical treatment

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic quality of preoperative hyperperfusion in CEUS (Contrast-enhanced ultrasound) / DCE-MRI (dynamic contrast-enhanced MRI) for the detection of infected non-unions.<br><br>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 Outcome Measures

Name	Time	Method
- Psychosocial evaluation: SF-12, preoperatively as well as 12 weeks, 6 months and 12 months postoperatively<br>- Pain: Visual analog scale, preoperatively as well as 12 weeks, 6 months and 12 months postoperatively<br>