Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCharite University, Berlin, Germany

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

Qualifiers

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 design

Treatments tested in this trial

  • CD8+TEMRA

Treatment groups

640 Participants
are divided into 1 treatment group

Sponsors and collaborators

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