Using carbon fiber screws to treat spinal metastatic disease
Official title: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial
Run by Copernicus Memorial Hospital · NCT06293157 · Data updated 2026-11-12
This study is testing if carbon fiber screws can better stabilize the spine for people with metastatic spinal disease compared to traditional titanium screws, while also improving imaging quality for treatment planning.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 226 (estimated) |
| Sponsor | Copernicus Memorial Hospital Academic / other |
| Locations | 5 sites (Bydgoszcz and 4 other locations) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2033 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06293157 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with metastatic spinal disease who have a good performance status and are eligible for stereotactic body radiotherapy.
✕Probably not a fit
Patients with primary spinal tumors, those with a life expectancy of less than three months, or those who cannot provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of carbon fiber transpedicular screws for stabilizing the spine in patients with metastatic spinal disease. The study compares the effectiveness of these carbon fiber implants against traditional titanium implants, particularly focusing on their impact on diagnostic imaging quality and treatment planning for stereotactic body radiotherapy. Eligible participants will have metastatic spinal disease and will be assessed for their ability to undergo surgical intervention. The trial aims to improve surgical outcomes and reduce complications associated with imaging artifacts caused by metal implants.
Why it matters
Potential benefit: If successful, this approach could enhance surgical treatment outcomes and improve the quality of life for patients with metastatic spinal disease.
How similar studies have gone: While the use of carbon fiber implants is a novel approach in this context, similar studies have shown promise in reducing imaging artifacts with non-metallic materials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Copernicus Memorial Hospital in Łódź, Poland
Lodz, Łódź Voivodeship, Poland Recruiting -
Department of Neurosurgery, Functional Neurosurgery and Stereotaxy, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, Poland Active not recruiting -
Professor Franciszek Łukaszczyk Oncology Center in Bydgoszcz - National Research Institute
Bydgoszcz, Poland Active not recruiting -
Department of Teleradiotherapy, Lower Silesian Center of Oncology, Pulmonology and Hematology
Wroclaw, Poland Active not recruiting -
University Center of Neurology and Neurosurgery, Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw, Poland Active not recruiting
Study contacts
- Principal investigator: Kamil Krystkiewicz, PhD — Department of Neurosurgery and Neurooncology, Copernicus Memoriał Hospital in Łódź
- Study coordinator: Kamil Krystkiewicz, PhD
- Email: kamil.krystkiewicz@gmail.com
- Phone: +48426895341
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.