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Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

RecruitingNAAges 18 Years - anyAllCopernicus Memorial Hospital
NCT06293157 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imagi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Metastatic spinal disease, * ECOG quality of life of 0-2, * Eligibility for SBRT treatment, * Expected survival time \>3 months, * Signed informed consent to participate in the study, * Sufficient organ capacity allowing to survive the perioperative period. Exclusion Criteria: * Primary tumor of the spine, * Age \<18 years old, * Expected survival time \<3 months, * Eligibility for palliative radiotherapy, * No informed consent to participate in the study, * Pregnancy or breastfeeding, * The advancement of the disease preventing the technical use of implants.
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What it tests

  • Transpedicular spinal stabilization - carbon fibers-based implants
  • Transpedicular spinal stabilization - titanium implants
  • Stereotactic body radiotherapy
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Where

5 sites
Department of Neurosurgery, Functional Neurosurgery and Stereotaxy, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, Poland
Professor Franciszek Łukaszczyk Oncology Center in Bydgoszcz - National Research Institute
Bydgoszcz, Poland
Department of Teleradiotherapy, Lower Silesian Center of Oncology, Pulmonology and Hematology
Wroclaw, Poland
University Center of Neurology and Neurosurgery, Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw, Poland
Copernicus Memorial Hospital in Łódź, Poland
Lodz, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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