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Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
Sponsor: Charite University, Berlin, Germany
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
640
Start Date
2016-12
Completion Date
2025-06
Last Updated
2024-10-26
Healthy Volunteers
No
Conditions
Interventions
CD8+TEMRA
Locations (7)
Clinic for Trauma, Hand and Reconstructive Surgery University Hospital Münster (UKM)
Münster, North Rhine-Westphalia, Germany
University Hospital University Centre for Orthopaedics and Trauma Surgery Dresden
Dresden, Saxony, Germany
University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig
Leipzig, Saxony, Germany
Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany
Charité Universitätsmedizin Berlin, Centre for Musculoskeletal Surgery (CMSC)
Berlin, State of Berlin, Germany
Vivantes Klinikum Spandau Berlin
Berlin, State of Berlin, Germany
Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg
Eisenberg, Thuringia, Germany