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

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.

Conditions

• Fracture Non Union
• Fracture Healing
• Long Bone Delayed-Union Fracture
• Humerus Shaft Fracture
• Forearm Fracture
• Femoral Neck Fractures
• Femur Distal Fracture
• Pertrochanteric Fracture of Femur
• Femoral Shaft Fracture
• Proximal Tibia Fracture
• Tibial Shaft Fracture
• Distal Tibia Fracture

Interventions

DIAGNOSTIC_TEST

CD8+TEMRA

Sponsors & Collaborators

• Unfallkrankenhaus Berlin

  collaborator OTHER

• Vivantes Klinikum Spandau

  collaborator UNKNOWN

• University Hospital Dresden

  collaborator OTHER

• Universitaetsklinikum Muenster

  collaborator UNKNOWN

• Leipzig University Hospital

  collaborator UNKNOWN

• Jena University Hospital

  collaborator OTHER

• Beckman Coulter, Inc.

  collaborator INDUSTRY

• Federal Ministry of Education and Reserach (BMBF)

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Simon Reinke, Phd · Charité Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT)

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2025-04-30

Completion

2025-06-30

Countries

• Germany

Study Locations