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RECRUITING
NCT06658379

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

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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