MaNGA – Methods against Non-Union: from Grassroots to clinical Application, subproject “Determination of local vascularization for diagnosis of (low-grade) infected non-union”

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038073

Enrollment

100

Registered

2026-01-08

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

M84.16

Interventions

Group 1: Patients with tibial non-union Study-Related Measures/Examinations: - Preoperative collection of peripheral blood - Intraoperative collection of tissue samples from the non-union zone - Exam

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - radiologically confirmed tibial non-union with no prospect of bone consolidation without further surgical intervention - planned surgical non-union revision with implant removal or replacement - the patient's non-union zone was examined using CEUS - written consent

Exclusion criteria

Exclusion criteria: - antibiotic therapy within the last 14 days prior to revision surgery - pregnancy

Design outcomes

Primary

Measure	Time frame
CEUS determined hypervascularization in the nonunion zone. Sensitivity and specificity of the extent of immunohistologically determined vascularisation in non-union tissue obtained intraoperatively for diagnosing infection in non-union. Sensitivity and specificity of preoperative systemic concentrations of angiogenesis and vascularisation markers, and their combination, in peripheral serum blood samples for the diagnosis of infection in non-union.	—

Measure

Time frame

CEUS determined hypervascularization in the nonunion zone. Sensitivity and specificity of the extent of immunohistologically determined vascularisation in non-union tissue obtained intraoperatively for diagnosing infection in non-union. Sensitivity and specificity of preoperative systemic concentrations of angiogenesis and vascularisation markers, and their combination, in peripheral serum blood samples for the diagnosis of infection in non-union.

—

Secondary

Measure	Time frame
Sensitivity and specificity of the preoperative CEUS-determined perfusion rate in the nonunion zone for diagnosing infection in nonunion. Correlation of the perfusion rate, as determined by CEUS, with the extent of vascularization in non-union tissue, as determined by immunohistochemistry, and with the concentrations of systemic angiogenesis and vascularization markers in serum. Correlation of the perfusion rate, as determined by CEUS, with membrane filtration of sonication fluid and the corresponding colony-forming unit (CFU) cut-off. Sensitivity and specificity of the proportion of CD38-positive regulatory T cells in peripheral blood for diagnosing infection in non-union.	—

Measure

Time frame

Sensitivity and specificity of the preoperative CEUS-determined perfusion rate in the nonunion zone for diagnosing infection in nonunion. Correlation of the perfusion rate, as determined by CEUS, with the extent of vascularization in non-union tissue, as determined by immunohistochemistry, and with the concentrations of systemic angiogenesis and vascularization markers in serum. Correlation of the perfusion rate, as determined by CEUS, with membrane filtration of sonication fluid and the corresponding colony-forming unit (CFU) cut-off. Sensitivity and specificity of the proportion of CD38-positive regulatory T cells in peripheral blood for diagnosing infection in non-union.

—

Countries

Germany

Contacts

Public ContactKatharina Trenkwalder

BG Unfallklinik Murnau Institut für Biomechanik

katharina.trenkwalder@bgu-murnau.de+49 8841 48 3059

Outcome results

None listed

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