Using carbon fiber screws to treat spinal metastatic disease
Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copernicus Memorial Hospital Academic / other |
| Locations | 5 sites (Bydgoszcz and 4 other locations) |
| Trial ID | NCT06293157 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bydgoszcz and 4 other locations
- 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)
- Copernicus Memorial Hospital in Łódź, Poland — Lodz, Łódź Voivodeship, Poland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.