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

This trial does not accept healthy volunteers

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 population

University Hospital UniversityCentre for Orthopaedics and Trauma Surgery Dresden Charité Universitätsmedizin Berlin Centre for Musculoskeletal Surgery Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg Clinic Trauma Hospital Berlin Berlin Vivantes Hospital Spandau Berlin Clinic University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CD8+TEMRA

    Diagnostic test

Treatment groups

640 Participants
are divided into 1 treatment group
Group A: fracture cohort1 intervention

Trial outcomes

Primary outcomes

1

Clinical assessement of the fracture consolidation at first study endpoint based on radiological images

Clinical assessement of the fracture consolidation (yes/no) based on radiological images at primary end point

Time frame
From surgery to 19 weeks post surgery

Secondary outcomes

1

clinical assessement of the fracture consolidation at second study endpoint based on radiological images

fracture consolidation (yes/no) after 36 weeks post surgery based on radiological images.

Time frame
From surgery to 36 weeks post surgery

Other outcomes

1

Ability to work

Period of return to work in days

Time frame
From surgery to 1 year post surgery
2

Proportion of subjects with an additional intervention independent of a surgical or non-surgical treatment to foster the fracture healing process

Number of surgically invasive and non-invasive measures

Time frame
From surgery to 1 year post surgery
3

Duration of Physiotherapy

Duration of physiotherapy sessions (units) done with a professional post-surgery.

Time frame
From surgery to 1 year post surgery
4

Weight bearing and fracture healing

Time to complete full weight bearing post surgery (weeks).

Time frame
From surgery to 1 year post surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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