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Study identifier: NCT06658379 Synced from ClinicalTrials.gov · July 28, 2026
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Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture

Condition: Fracture Non Union · Fracture Healing · Long Bone Delayed-Union Fracture  ·  Sponsor: Charite University, Berlin, Germany

PhaseN/A
Planned participants640
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Simon Reinke, Phd  ·  +49 (0)30-450-659617  ·  simon.reinke@bih-charite.de

Sven Geißler, Phd  ·  +49(0)30450 559539  ·  sven.geissler@bih-charite.de

Always discuss trial participation with your own doctor first.

Locations (7)

Clinic for Trauma, Hand and Reconstructive Surgery University Hospital Münster (UKM)Münster, North Rhine-Westphalia, GermanyRecruiting
University Hospital University Centre for Orthopaedics and Trauma Surgery DresdenDresden, Saxony, GermanyRecruiting
University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery LeipzigLeipzig, Saxony, GermanyRecruiting
Unfallkrankenhaus BerlinBerlin, State of Berlin, GermanyRecruiting
Charité Universitätsmedizin Berlin, Centre for Musculoskeletal Surgery (CMSC)Berlin, State of Berlin, GermanyRecruiting
Vivantes Klinikum Spandau BerlinBerlin, State of Berlin, GermanyRecruiting
Clinic for Orthopaedics and Trauma Surgery Jena/EisenbergEisenberg, Thuringia, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT06658379