Differentiation of aseptic and infectious pseudarthrosis using molecularbiological, histopathological and chemical criteria

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014657

Enrollment

120

Registered

2018-04-26

Start date

2019-01-16

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

Interventions

Group 1: Surgical Revision of a pseudarthrosis of femural or tibial shaft Group 2: Surgical removal of metallic implant after femur or Tibia fracture

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Study group: Pseudarthrosis located at the shaft of Long bones of lower extremity diagnosed by computertomography (no bone healing > 6 months) planned surgical Revision for Treatment of pseudarthrosis Control Group: normal bone healing after shaft fracture of Long bones of lower extremity planned implant removal

Exclusion criteria

Exclusion criteria: Pseudarthroses at several Body regions at the same time malignant Tumor autoimune disease immunosuppressive therapy floride infection of other origin pregnancy

Design outcomes

Primary

Measure	Time frame
C-reactive Protein (CRP) pre-operative	—

Secondary

Measure	Time frame
histologic and molecularbiologic results (histopathological Investigation of pseudarthrotic and periimplant tissue) Pattern of inflammatory and regulative cytokines (IL-1ß, IFN, TNFa, IL-6, IL-17) and presence of antimicrobial peptides Incompatibility of implant measured by Titanic sensibility test	—

Countries

Germany

Contacts

Public ContactSimon Hackl

BG Unfallklinik

simon.hackl@bgu-murnau.de08841/480

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 21, 2026