About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
University Hospital UniversityCentre for Orthopaedics and Trauma Surgery Dresden Charité Universitätsmedizin Berlin Centre for Musculoskeletal Surgery Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg Clinic Trauma Hospital Berlin Berlin Vivantes Hospital Spandau Berlin Clinic University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig
Trial design
Cohort
Prospective
Treatments tested in this trial
CD8+TEMRA
Diagnostic test
Treatment groups
Trial outcomes
Primary outcomes
Clinical assessement of the fracture consolidation at first study endpoint based on radiological images
Clinical assessement of the fracture consolidation (yes/no) based on radiological images at primary end point
Secondary outcomes
clinical assessement of the fracture consolidation at second study endpoint based on radiological images
fracture consolidation (yes/no) after 36 weeks post surgery based on radiological images.
Other outcomes
Ability to work
Period of return to work in days
Proportion of subjects with an additional intervention independent of a surgical or non-surgical treatment to foster the fracture healing process
Number of surgically invasive and non-invasive measures
Duration of Physiotherapy
Duration of physiotherapy sessions (units) done with a professional post-surgery.
Weight bearing and fracture healing
Time to complete full weight bearing post surgery (weeks).
Sponsors and contacts
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Charite University, Berlin, Germany
Lead sponsor
Unfallkrankenhaus Berlin
Collaborator
Vivantes Klinikum Spandau
Collaborator
University Hospital Dresden
Collaborator
Universitaetsklinikum Muenster
Collaborator
Leipzig University Hospital
Collaborator
Jena University Hospital
Collaborator
Beckman Coulter, Inc.
Collaborator
Federal Ministry of Education and Reserach (BMBF)
Collaborator