Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

Официальное название

Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial

Обзор

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 imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants. 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.

Вмешательства

• Процедура 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.
• Процедура 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.
• Лучевая терапия 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.

Первичные конечные точки

• The assessment of time to local recurrence after treatment with SBRT. [Срок оценки: 5 years]
• The assessment of frequency of local recurrence after treatment with SBRT. [Срок оценки: 5 years]

Вторичные конечные точки (11)

• DICE convergence factor evaluation between groups of patients. [Срок оценки: 1 day]
• The subjective difficulty of planning radiotherapy treatment. [Срок оценки: 1 day]
• The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC). [Срок оценки: 5 years]
• Failure rate of stabilizing systems. [Срок оценки: 5 years]
• Pain assessment on the VAS scale between groups. [Срок оценки: 5 years]
• Frequency of postoperative infections. [Срок оценки: 5 years]
• Differences in dosimetric parameter Dmin PTV/CTV. [Срок оценки: 1 day]
• Differences in dosimetric parameter D95. [Срок оценки: 1 day]
• Differences in dosimetric parameter D98. [Срок оценки: 1 day]
• Differences in dosimetric parameter D100. [Срок оценки: 1 day]
• Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)). [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 5 центров

• Department of Neurosurgery, Functional Neurosurgery and Stereotaxy, Dr. Jan Biziel Univers — Bydgoszcz
• Professor Franciszek Łukaszczyk Oncology Center in Bydgoszcz - National Research Institute — Bydgoszcz
• Department of Teleradiotherapy, Lower Silesian Center of Oncology, Pulmonology and Hematol — Wroclaw
• University Center of Neurology and Neurosurgery, Jan Mikulicz-Radecki University Clinical — Wroclaw
• Copernicus Memorial Hospital in Łódź, Poland — Lodz

Публикации

• 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. PMID 32173153
• 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. PMID 28815357
• 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. PMID 28300369
• 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. PMID 28478252
• 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. PMID 33932921
• 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. PMID 29497852
• Krystkiewicz K, Kuncman L, Orzechowska MJ, Pytlarz B, Kowal A, Siwak M, Fijuth J, Ranoszek K, Pajdzinski M, Zubiel K, Arczewski F, Dziedzic K, Tosik M. CARBOMETASPINE: protocol for a multicenter, prospective, randomized controlled trial of carbonfiber spinal fixation in metastatic disease. BMC Cancer. 2025 Sep 2;25(1):1409. doi: 10.1186/s12885-025-14731-7. PMID 40898139

Идентификаторы

NCT: NCT06293157 · 2023/ABM/01/00013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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