Actively Recruiting
Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
Led by Charite University, Berlin, Germany · Updated on 2024-10-26
640
Participants Needed
7
Research Sites
443 weeks
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
U
Unfallkrankenhaus Berlin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects
- Between 18 and 80 years of age at screening
- Closed fractures
- Fractures of the humerus shaft, forearm shaft, femur, or tibia
- Monotrauma or comparable trauma with similar post-surgery mobilization
- Osteosynthesis performed
- Signed informed consent form
- Legal capacity
You will not qualify if you...
- Cancer-related fractures
- Periprosthetic fractures
- Known active Hepatitis B or Hepatitis C infection at screening
- Known HIV infection, severe uncontrolled inflammatory or autoimmune disease
- Active malignancy or history of malignancy within 5 years before screening
- Moderate to severe dementia or severe psychiatric disorder
- Drug or alcohol abuse in the past 12 months
- History of bone marrow or solid organ transplantation
- Previous allogeneic cell therapy or recent autologous cell therapy within 12 months
- Pregnancy
- Currently enrolled in another investigational drug or device trial or within 30 days of ending such a trial
- Detained or institutionalized by court or administrative order
- Deemed unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Clinic for Trauma, Hand and Reconstructive Surgery University Hospital Münster (UKM)
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
2
University Hospital University Centre for Orthopaedics and Trauma Surgery Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
3
University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
4
Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany, 12683
Actively Recruiting
5
Charité Universitätsmedizin Berlin, Centre for Musculoskeletal Surgery (CMSC)
Berlin, State of Berlin, Germany, 13353
Actively Recruiting
6
Vivantes Klinikum Spandau Berlin
Berlin, State of Berlin, Germany, 13585
Actively Recruiting
7
Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg
Eisenberg, Thuringia, Germany, 07607
Actively Recruiting
Research Team
S
Simon Reinke, Phd
CONTACT
S
Sven Geißler, Phd
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here