Metastatic Spinal Cord CompressionCarboMetaspineNCT06293157
Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease
A study testing Transpedicular spinal stabilization - carbon fibers-based implants, Transpedicular spinal stabilization - titanium implants and Stereotactic body radiotherapy in people with Metastatic Spinal Cord Compression and Metastasis Spine, run by Copernicus Memorial Hospital at 5 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Spinal Cord Compression, Metastasis Spine
- What is being tested?
- Transpedicular spinal stabilization - carbon fibers-based implants, Transpedicular spinal stabilization - titanium implants and Stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 5 sitesPoland
- Study dates
- 1 Dec 2023to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Poland5 sites, 1 recruiting
- Active, not recruiting
Department of Neurosurgery, Functional Neurosurgery and Stereotaxy, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz
- Active, not recruiting
Professor Franciszek Łukaszczyk Oncology Center in Bydgoszcz - National Research Institute
Bydgoszcz
- Recruiting
Copernicus Memorial Hospital in Łódź, Poland
Lodz, Łódź Voivodeship, 93-513
Kamil Krystkiewicz, PhD, +48426895341, kamil.krystkiewicz@gmail.com
- Active, not recruiting
Department of Teleradiotherapy, Lower Silesian Center of Oncology, Pulmonology and Hematology
Wroclaw
- Active, not recruiting
University Center of Neurology and Neurosurgery, Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw
About this study
Official title: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial
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.
Read more
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.
- Being tested
- Transpedicular spinal stabilization - carbon fibers-based implants, Transpedicular spinal stabilization - titanium implants, Stereotactic body radiotherapy
- Keywords
- metastatic spinal disease, stereotactic body radiotherapy, spinal cord compression, carbon fiber reinforced implants
- Medical subject headings
- Spinal Cord Compression, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpedicular spinal stabilization - carbon fibers-based implantsProcedure or surgery
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 implantsProcedure or surgery
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 radiotherapyRadiation
Also called SBRT
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.
| Study group | Role | What they receive |
|---|---|---|
| Transpedicular spinal stabilization using carbon system + SBRT | Experimental | 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) Receives: Procedure: Transpedicular spinal stabilization - carbon fibers-based implants; Radiation: Stereotactic body radiotherapy |
| Transpedicular spinal stabilization using titanium system + SBRT | Active comparator | 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) Receives: Procedure: Transpedicular spinal stabilization - titanium implants; Radiation: Stereotactic body radiotherapy |
| SBRT + Transpedicular spinal stabilization using titanium system | Sham comparator | 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 Receives: Procedure: Transpedicular spinal stabilization - titanium implants; Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of time to local recurrence after treatment with SBRT.
Measured: 5 years
The assessment of frequency of local recurrence after treatment with SBRT.
Measured: 5 years
Secondary outcomes (11)
DICE convergence factor evaluation between groups of patients.
The use of convergence factor assessment will allow for comparison of similarity in planned SBRT between all groups. This will allow an indirect assessment of difficulties in planning treatment by a radiotherapist using objective tools.
Measured: 1 day
The subjective difficulty of planning radiotherapy treatment.
Using a numerical scale from 0-10, the radiotherapist will assess the difficulty of planning, tumor coverage, and delineation of the spinal cord depending on the group assessed in the study.
Measured: 1 day
The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC).
Titanium instrumentation generates significant artifacts in radiological imaging used for radiotherapy planning. The use of opaque, radiolucent material allows for radiotherapy planning to cover a smaller area. This may reduce the incidence of radiation-related complications in nearby organs (OAR - organ at risk). These complications will be assessed by the radiation therapist according to the standardized NCI CTC scale. Potentially smaller quantity of organ complications could be an advantage supporting the use of carbon implants.
Measured: 5 years
Failure rate of stabilizing systems.
Titanium and carbon fiber show similar biocompatibility. The biomechanical properties of these materials are also similar. In vitro studies have shown a similar effect failure rate of carbon pedicle screws compared to standard titanium ones. However, carbon rods have greater flexibility and structure connected using these may show more frequent loosening in vivo, especially in cases with impaired sagittal balance. This was not an issue analyzed in the literature. The frequency of instrument failure is of great importance for clinical practice because most such cases require operative revision.
Measured: 5 years
Pain assessment on the VAS scale between groups.
One of the goals of surgical treatment is to treat mechanical pain caused by segmental instability. SBRT is a good method of treating biological pain. There are no comparisons of analgesic effects between transpedicular systems. Greater pain reduction allows for more effective and longer ability to walk, lower consumption of painkillers, and lower incidence of complications related to immobilization (thrombosis, bedsores, respiratory infections), which also has pharmacoeconomic implications.
Measured: 5 years
Frequency of postoperative infections.
Postoperative wound infections are an inherent complication of surgical procedures. The longer the procedure, the more often inflammatory complications are observed, especially in oncological population, which has a higher average age of treated patients, a greater number of burdens, frequent immunosuppression due to systemic treatment, and malnutrition in the form of decreased biochemical parameters (total protein and albumin). Titanium has good properties in this aspect. Bacterial biofilms, is rarely formed on it, which means that patients can be treated more often without the need to remove the implants. It is unclear how carbon fiber system will perform in these cases. There are not made of metal, but of carbon fiber embedded in polymer. Assessment of the frequency of inflammatory complications and their course will provide the answer to whether This instrumentation allows for a similar management strategy in clinical settings.
Measured: 5 years
Differences in dosimetric parameter Dmin PTV/CTV.
Measured: 1 day
Differences in dosimetric parameter D95.
Measured: 1 day
Differences in dosimetric parameter D98.
Measured: 1 day
Differences in dosimetric parameter D100.
Measured: 1 day
Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metastatic Spinal Cord CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copernicus Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Kamil Krystkiewicz, Copernicus Memorial Hospital
- Investigators
- Kamil Krystkiewicz, PhD, Principal investigator, Department of Neurosurgery and Neurooncology, Copernicus Memoriał Hospital in Łódź
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293157
- Sponsor's protocol ID
- 2023/ABM/01/00013
- Acronym
- CarboMetaspine
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32173153Boriani 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.
PubMed 28815357Nevelsky 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.
PubMed 28300369Ringel 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.
PubMed 28478252Neal 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.
PubMed 33932921Lindtner 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.
PubMed 29497852Krystkiewicz 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.
PubMed 40898139
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT06293157
- Acronym / sponsor ID
- CarboMetaspine / 2023/ABM/01/00013
- Keywords
- metastatic spinal disease, stereotactic body radiotherapy, spinal cord compression, carbon fiber reinforced implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Copernicus Memorial HospitalUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transpedicular spinal stabilization using carbon system + SBRT | Experimental | Procedure: Transpedicular spinal stabilization - carbon fibers-based implants, Radiation: Stereotactic body radiotherapyTranspedicular 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 using titanium system + SBRT | Active comparator | Procedure: Transpedicular spinal stabilization - titanium implants, Radiation: Stereotactic body radiotherapyTranspedicular 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) |
| SBRT + Transpedicular spinal stabilization using titanium system | Sham comparator | Procedure: Transpedicular spinal stabilization - titanium implants, Radiation: Stereotactic body radiotherapyTranspedicular 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transpedicular spinal stabilization - carbon fibers-based implantsTranspedicular 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. | Procedure or surgery | Transpedicular spinal stabilization using carbon system + SBRT |
| Transpedicular spinal stabilization - titanium implantsTranspedicular 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. | Procedure or surgery | SBRT + Transpedicular spinal stabilization using titanium system, Transpedicular spinal stabilization using titanium system + SBRT |
| Stereotactic body radiotherapyAlso: SBRTSpinal 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. | Radiation | SBRT + Transpedicular spinal stabilization using titanium system, Transpedicular spinal stabilization using carbon system + SBRT, Transpedicular spinal stabilization using titanium system + SBRT |
Primary outcome
The assessment of time to local recurrence after treatment with SBRT.
Time frame: 5 years
The assessment of frequency of local recurrence after treatment with SBRT.
Time frame: 5 years
11 secondary outcomes
DICE convergence factor evaluation between groups of patients.
Time frame: 1 day
The subjective difficulty of planning radiotherapy treatment.
Time frame: 1 day
The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC).
Time frame: 5 years
Failure rate of stabilizing systems.
Time frame: 5 years
Pain assessment on the VAS scale between groups.
Time frame: 5 years
Frequency of postoperative infections.
Time frame: 5 years
Differences in dosimetric parameter Dmin PTV/CTV.
Time frame: 1 day
Differences in dosimetric parameter D95.
Time frame: 1 day
Differences in dosimetric parameter D98.
Time frame: 1 day
Differences in dosimetric parameter D100.
Time frame: 1 day
Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)).
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 32173153Cofano 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.
- Background: PubMed 28815357Boriani 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.
- Background: PubMed 28300369Nevelsky 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.
- Background: PubMed 28478252Ringel 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.
- Background: PubMed 33932921Neal 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.
- Background: PubMed 29497852Lindtner 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.
- Derived from this study: PubMed 40898139Krystkiewicz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamil Krystkiewicz, PhD principal investigator
Department of Neurosurgery and Neurooncology, Copernicus Memoriał Hospital in Łódź
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpedicular spinal stabilization - carbon fibers-based implants, Transpedicular spinal stabilization - titanium implants and Stereotactic body radiotherapy in people with Metastatic Spinal Cord Compression and Metastasis Spine, run by Copernicus Memorial Hospital at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamil Krystkiewicz, PhD (+48426895341, kamil.krystkiewicz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of time to local recurrence after treatment with SBRT. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293157, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.