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. 2025 Sep 2;25(1):1409.
doi: 10.1186/s12885-025-14731-7.

CARBOMETASPINE: protocol for a multicenter, prospective, randomized controlled trial of carbonfiber spinal fixation in metastatic disease

Kamil Krystkiewicz  1 , Łukasz Kuncman  2 , Magdalena Julita Orzechowska  3 , Beata Pytlarz  4 , Aleksander Kowal  4 , Mateusz Siwak  4 , Jacek Fijuth  2 , Kinga Ranoszek  2 , Mateusz Pajdziński  2 , Katarzyna Zubiel  4 , Filip Arczewski  4 , Karol Dziedzic  4 , Marcin Tosik  4
Affiliations

CARBOMETASPINE: protocol for a multicenter, prospective, randomized controlled trial of carbonfiber spinal fixation in metastatic disease

Kamil Krystkiewicz et al. BMC Cancer. .

Abstract

Background: Spinal metastases frequently cause neurological compromise and mechanical instability. Titanium fixation limits postoperative imaging and hinders stereotactic body radiotherapy (SBRT) planning because of artefacts.

Methods: CARBOMETASPINE is a multicentre, prospective, randomised controlled trial. A total of 226 adults with unstable or epidurally infiltrating spinal metastases will be randomised 1 : 1 : 1 to: (I) carbonfibre/PEEK fixation + postoperative SBRT (5 × 5 Gy); (II) titanium fixation + postoperative SBRT; (III) preoperative SBRT + titanium fixation. The primary endpoint is progressionfree survival of the treated spinal level. Secondary endpoints include dosimetric quality, pain (NRS), surgical complication rates and implant failure.

Discussion: Radiolucent carbonfibre implants may improve the geometric accuracy of SBRT planning and enhance local tumour control while preserving mechanical strength. This protocol follows SPIRIT recommendations and will provide robust evidence on clinical benefits and implementation barriers of carbonfibre systems.

Trial registration: ClinicalTrials.gov, NCT06293157. Registered 17 February 2024.

Supplementary Information: The online version contains supplementary material available at 10.1186/s12885-025-14731-7.

Keywords: Carbon-fiber fixation; Metastatic spinal disease; Stereotactic body radiotherapy; Transpedicular stabilization.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The protocol was approved by the Bioethics Committee of the Polish Mother’s Memorial Health Centre Institute, Łódź (ref. 90/2022; amendments 69/2024 and 53/2025). All participants provide written informed consent before enrolment. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of participants according to the Standard Protocol Items: Recommendations for Interventional Trials 2013 Statement. ECOG, Eastern Cooperative Oncology Group; SBRT, Stereotactic Body Radiotherapy
Fig. 2
Fig. 2
Schedule of enrolment, surgical and radiotherapy interventions, and time-point assessments
See this image and copyright information in PMC

References

    1. 1, Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12(20):s6243–9. 10.1158/1078-0432.CCR-06-0931. - PubMed
    1. Shakil H, Malhotra AK, Badhiwala JH, et al. Contemporary trends in the incidence and timing of spinal metastases: a populationbased study. Neurooncol Adv. 2024;6(1):vdae051. 10.1093/noajnl/vdae051. - PMC - PubMed
    1. Valesin Filho ES, de Abreu LC, Lima GH, et al. Pain and quality of life in patients undergoing radiotherapy for spinal metastatic disease treatment. Int Arch Med. 2013;6(1): 6. 10.1186/1755-7682-6-6. - PMC - PubMed
    1. Jacobs WB, Perrin RG. Evaluation and treatment of spinal metastases: an overview. Neurosurg Focus. 2001;11(6):E11. 10.3171/foc.2001.11.6.11. - PubMed
    1. Curtin M, Piggott RP, Murphy EP, et al. Spinal metastatic disease: a review of the role of the multidisciplinary team. Orthop Surg. 2017;9(2):145–51. 10.1111/os.12334. - PMC - PubMed

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