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
8 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
Researchers are investigating the use of CD8+ TEMRA cells as a biomarker to predict healing outcomes after fractures, particularly focusing on patients who experience delayed healing or non-union. This prospective study aims to distinguish between normal healing, delayed healing, and pseudarthrosis by measuring the expression of these immune cells before surgery. The goal is to improve early identification of patients at risk for poor healing, which currently lacks reliable prognostic methods and leads to increased interventions, longer hospital stays, and work incapacity. The study involves patients with closed fractures of the humerus-shaft, forearm-shaft, femur, or tibia who undergo osteosynthesis surgery. Blood samples will be taken upon hospital admission to measure preoperative CD8+ TEMRA cell levels. Healing progress will be monitored through routine clinical and radiological examinations, including X-rays and CT scans, as well as functional assessments and quality of life questionnaires. Key study endpoints are set at 17-19 weeks for detecting delayed healing and 34-36 weeks for pseudarthrosis, with blinded analysis comparing biomarker levels to actual healing outcomes. Participants will have scheduled visits integrated with their standard clinical care for fracture monitoring. Researchers will collect data using imaging, clinical exams, and patient-reported outcomes like the SF-36 health survey. The main measure is the clinical assessment of fracture consolidation at 19 weeks post-surgery, with a secondary assessment at 36 weeks. This study is designed to validate CD8+ TEMRA cells as a predictive marker under routine conditions, potentially guiding individualized treatment strategies to enhance fracture healing.
CONDITIONS
Brief 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 of the humerus-shaft, forearm-shaft, femur, or tibia
- Suffering monotrauma or similar with comparable post-surgery mobilization
- Undergoing osteosynthesis surgery
- Signed informed consent form
- Legal capacity to participate
You will not qualify if you...
- Cancer-related fractures
- Periprosthetic fractures
- Known active infection with Hepatitis B or Hepatitis C virus at screening
- Known HIV infection, severe uncontrolled inflammatory or autoimmune disease
- Active malignancy or history of malignancy within 5 years prior to screening
- Moderate to severe dementia or severe psychiatric disorder
- History of drug or alcohol abuse in the past 12 months
- History of bone marrow or solid organ transplantation
- Prior exposure to allogeneic or recent autologous cell-based therapy
- Pregnancy
- Currently enrolled in another investigational device or drug trial or within 30 days of such trial
- Detained or institutionalized under court or administrative order
- Deemed unsuitable for participation by the investigator due to compliance concerns
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Blood sampling on arrival at the hospital is used to determine the preoperative value of CD8+TEMRA cells as a biomarker before surgery.
1 visit (in-person)
Duration - Up to 36 weeks post surgery
Participants who undergo routine care are observed through clinical, radiological, and functional routine checks to monitor fracture healing.
Visits aligned with clinical radiological and functional routine checks over approximately 36 weeks
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
S
Sven Geißler, Phd
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
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