Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease
NCT ID: NCT06293157
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
226 participants
INTERVENTIONAL
2023-12-01
2033-12-31
Brief Summary
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Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.
Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.
Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transpedicular spinal stabilization using carbon system + SBRT
Transpedicular spinal stabilization using a radiolucent composite system made of carbon fibers and PEEK followed by stereotactic radiotherapy of the spine at a dose of 5x5 Gy (25 Gy in the total dose)
Transpedicular spinal stabilization - carbon fibers-based implants
Transpedicular stabilization with carbon fiber and PEEK-based implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.
Stereotactic body radiotherapy
Spinal tumors will be treated with stereotactic body radiotherapy at a dose of 5x5 Gy (25 Gy in a total dose); either prior to or post-surgical treatment, accordingly the allocation to one of the study arms.
Transpedicular spinal stabilization using titanium system + SBRT
Transpedicular spinal stabilization using a titanium system followed by stereotactic radiotherapy of the spine at a dose of 5x5 Gy (25 Gy in the total dose)
Transpedicular spinal stabilization - titanium implants
Transpedicular stabilization with titanium implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.
Stereotactic body radiotherapy
Spinal tumors will be treated with stereotactic body radiotherapy at a dose of 5x5 Gy (25 Gy in a total dose); either prior to or post-surgical treatment, accordingly the allocation to one of the study arms.
SBRT + Transpedicular spinal stabilization using titanium system
Transpedicular spinal stabilization using a titanium system preceded with stereotactic spine radiotherapy at a dose of 5x5 Gy (25 Gy in the total dose) as the first stage of treatment
Transpedicular spinal stabilization - titanium implants
Transpedicular stabilization with titanium implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.
Stereotactic body radiotherapy
Spinal tumors will be treated with stereotactic body radiotherapy at a dose of 5x5 Gy (25 Gy in a total dose); either prior to or post-surgical treatment, accordingly the allocation to one of the study arms.
Interventions
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Transpedicular spinal stabilization - carbon fibers-based implants
Transpedicular stabilization with carbon fiber and PEEK-based implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.
Transpedicular spinal stabilization - titanium implants
Transpedicular stabilization with titanium implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.
Stereotactic body radiotherapy
Spinal tumors will be treated with stereotactic body radiotherapy at a dose of 5x5 Gy (25 Gy in a total dose); either prior to or post-surgical treatment, accordingly the allocation to one of the study arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medical Research Agency, Poland
OTHER_GOV
Copernicus Memorial Hospital
OTHER
Responsible Party
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Kamil Krystkiewicz
Principal Investigator
Principal Investigators
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Kamil Krystkiewicz, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery and Neurooncology, Copernicus Memoriał Hospital in Łódź
Locations
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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, Łódź Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Cofano F, Di Perna G, Monticelli M, Marengo N, Ajello M, Mammi M, Vercelli G, Petrone S, Tartara F, Zenga F, Lanotte M, Garbossa D. Carbon fiber reinforced vs titanium implants for fixation in spinal metastases: A comparative clinical study about safety and effectiveness of the new "carbon-strategy". J Clin Neurosci. 2020 May;75:106-111. doi: 10.1016/j.jocn.2020.03.013. Epub 2020 Mar 12.
Boriani S, Tedesco G, Ming L, Ghermandi R, Amichetti M, Fossati P, Krengli M, Mavilla L, Gasbarrini A. Carbon-fiber-reinforced PEEK fixation system in the treatment of spine tumors: a preliminary report. Eur Spine J. 2018 Apr;27(4):874-881. doi: 10.1007/s00586-017-5258-5. Epub 2017 Aug 16.
Nevelsky A, Borzov E, Daniel S, Bar-Deroma R. Perturbation effects of the carbon fiber-PEEK screws on radiotherapy dose distribution. J Appl Clin Med Phys. 2017 Mar;18(2):62-68. doi: 10.1002/acm2.12046. Epub 2017 Feb 7.
Ringel F, Ryang YM, Kirschke JS, Muller BS, Wilkens JJ, Brodard J, Combs SE, Meyer B. Radiolucent Carbon Fiber-Reinforced Pedicle Screws for Treatment of Spinal Tumors: Advantages for Radiation Planning and Follow-Up Imaging. World Neurosurg. 2017 Sep;105:294-301. doi: 10.1016/j.wneu.2017.04.091. Epub 2017 May 3.
Neal MT, Richards AE, Curley KL, Patel NP, Ashman JB, Vora SA, Kalani MA. Carbon fiber-reinforced PEEK instrumentation in the spinal oncology population: a retrospective series demonstrating technique, feasibility, and clinical outcomes. Neurosurg Focus. 2021 May;50(5):E13. doi: 10.3171/2021.2.FOCUS20995.
Lindtner RA, Schmid R, Nydegger T, Konschake M, Schmoelz W. Pedicle screw anchorage of carbon fiber-reinforced PEEK screws under cyclic loading. Eur Spine J. 2018 Aug;27(8):1775-1784. doi: 10.1007/s00586-018-5538-8. Epub 2018 Mar 1.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2023/ABM/01/00013
Identifier Type: -
Identifier Source: org_study_id