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Background <p>Spinal metastases frequently cause neurological compromise and mechanical instability. Titanium fixation limits postoperative imaging and hinders stereotactic body radiotherapy (SBRT) planning because of artefacts.</p> Methods <p>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&#xa0;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.</p> Discussion <p>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.</p> Trial registration <p>ClinicalTrials.gov, NCT06293157. Registered 17 February 2024.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月2日

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

摘要

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.