Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
Trial Parameters
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Brief Summary
In approx. 10-15% of all fracture patients, there is a prolonged healing time or even a complete absence of fracture healing (non-union). As a result, these patients require further surgical interventions, combined with renewed or prolonged hospitalisation/rehabilitation and incapacity to work. To summarise, this therefore represents a serious socio-economic problem. At present, there is no prognostic method for the early prediction of patients at risk of a disturbed healing process. However, if these patients are successfully stratified, there are already a variety of therapeutic strategies available to additionally stimulate fracture healing. Therefore, the aim is to conduct a prospective clinical study to validate CD8+ TEMRA cells as a prognostic marker of impaired fracture healing. The investigators assume that preoperative CD8+ TEMRA cell expression represents a prognostic biomarker with high diagnostic precision for differentiating between a) normal healing patients, b) delayed healing patients and c) pseudarthrosis patients. Furthermore, the sensitivity and specificity should be high enough, health-economically significant and realisable in clinical routine.
Eligibility Criteria
Inclusion Criteria: * male or female subjects * subjects \> 18 to 80 years of age at the time of screening * closed fractures * fractures of the humerus-shaft, forearm-shaft, femur and tibia * Subjects suffering monotrauma or comparable with monotrauma, due to comparable post-surgery mobilisation * osteosynthesis * subject has signed an informed consent form * legal capacity Exclusion Criteria: * cancer related fractures * periprosthetic fractures * known active Hepatitis B virus or Hepatitis C virus infection at screening * known human immunodeficiency virus (HIV) infection, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease * active malignancy or history of malignancy within 5 years prior to screening * known diagnosis of moderate to severe dementia based on subject's medical history or severe psychiatric disorder * known history of drug or alcohol abuse in the past 12 months, based on self-report or medical r