RecruitingNCT06658379

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


Sponsor

Charite University, Berlin, Germany

Enrollment

640 participants

Start Date

Dec 1, 2016

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying CD8+TEMRA for people with distal tibia fracture, femoral neck fractures, and other related conditions. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCD8+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

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NCT06658379


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