Autoimmunity
Conditions
Keywords
trauma, immunological reaction to trauma, pertrochanteric femoral fracture, antinuclear antibodies, activation of innate immunity, adaptive immunity
Brief summary
To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.
Detailed description
This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.
Interventions
DIAGNOSTIC_TESTComparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.
To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pertrochanteric femoral fracture (≤7 days) * planned gamma nail osteosynthesis * ability to give written informed consent
Exclusion criteria
* Severe hepatic and renal failure * current active oncological disease * current immunosuppressive or biological therapy * known systemic autoimmune disease * foreseeable lack of complete follow-up (e.g. due to generally poor health) * cognitive impairment (delirium, dementia, alteration of consciousness) * insufficient knowledge of project language * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ANA | Preoperative (1-2 days preoperative) and 12 weeks postoperative | Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA) | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative | serum level of Anti-dsDNA (U/ml) |
| Change in Antibody level against Anti-Cardiolipin | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative | serum level of Anti-Cardiolipin (U/ml) |
| Change in Antibody level against complement component C1q (Anti-C1q) | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative | serum level of C1q (U/ml) |
| Change in ANA | 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative | Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy) |
| Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells | Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative | Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells (cells/ml) |
| Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII) | Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative | Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII) |
| Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro) | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative | serum level of Anti-SSA/Ro (U/ml) |
Countries
Switzerland
Outcome results
None listed