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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line. | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ANA | 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 | Preoperative (1-2 days preoperative) and 12 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ANA | Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy) | 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative |
| Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute pertrochanteric fracture in whom an operation (gamma-nail osteosynthesis) is planned at the University Hospital Basel.
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| Name | Affiliation | Role |
|---|---|---|
| Eliska Potlukova, PhD | Klinik für Innere Medizin, Universitätsspital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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serum samples of each subject in a form of biobank (TATA-Biobank) in order to allow future analyses (e.g. emerging biomarkers in relation to trauma).
serum level of Anti-dsDNA (U/ml) |
| Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative |
| Change in Antibody level against Anti-Cardiolipin | serum level of Anti-Cardiolipin (U/ml) | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative |
| Change in Antibody level against complement component C1q (Anti-C1q) | serum level of C1q (U/ml) | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative |
| Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro) | serum level of Anti-SSA/Ro (U/ml) | Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months 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 | 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) | 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 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 |