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Background <p>Accurate cranial fixation is fundamental to the precision and safety of Gamma Knife Radiosurgery (GKRS). Traditional invasive frames, while reliable, limit patient comfort and adaptability for multi-session procedures. This study introduces and validates a reusable, 3D-printed head fixation frame made from polyethylene terephthalate glycol (PETG), engineered to provide mechanical stability and compatibility with the Leksell Gamma Knife Icon<sup>®</sup>.</p> Methods <p>The PETG frame was modelled in SolidWorks<sup>®</sup> and analysed mechanically using ANSYS<sup>®</sup> 2022 to evaluate deformation, stress distribution, and safety factors under tightening forces from 50&#xa0;N to 160&#xa0;N. Phantom dosimetry was performed with a CC13 + F ionisation chamber to determine dose attenuation. Clinical validation included 15 patients undergoing hypofractionated GKRS. Cone-beam CT (CBCT) and High-Definition Motion Management (HDMM) were used for alignment and motion monitoring. Statistical comparison of motion parameters was performed using one-way ANOVA.</p> Results <p>Finite element analysis revealed a maximum von Mises stress of 10.36&#xa0;MPa, well below PETG’s yield strength (53&#xa0;MPa). Phantom testing showed a mean dose attenuation of 3.8%, confirming negligible influence on radiation accuracy. Clinical analysis demonstrated an average patient motion of 0.44 ± 0.22&#xa0;mm, with only 40% of cases showing transient deviations beyond 1.5&#xa0;mm. ANOVA indicated a significant difference in motion distribution among sessions (<i>p</i> = 0.041). Patients rated the frame as comfortable and non-intimidating, with no major skin reactions.</p> Conclusion <p>The PETG frame offers a reusable, non-invasive, and cost-effective immobilization alternative for GKRS. Its proven mechanical reliability, radiological transparency, and compatibility with CBCT and HDMM systems establish it as a sustainable advancement in modern radiosurgical head fixation technology.</p>

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A reusable and universal size polyethylene terephthalate glycol head fixation device for Gamma Knife Radiosurgery: a prospective comparative cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月29日

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  • Rafal Thamer Ibrahim,
  • Moneer K. Faraj,
  • Auns Q.H. Al-Neami

摘要

Background

Accurate cranial fixation is fundamental to the precision and safety of Gamma Knife Radiosurgery (GKRS). Traditional invasive frames, while reliable, limit patient comfort and adaptability for multi-session procedures. This study introduces and validates a reusable, 3D-printed head fixation frame made from polyethylene terephthalate glycol (PETG), engineered to provide mechanical stability and compatibility with the Leksell Gamma Knife Icon®.

Methods

The PETG frame was modelled in SolidWorks® and analysed mechanically using ANSYS® 2022 to evaluate deformation, stress distribution, and safety factors under tightening forces from 50 N to 160 N. Phantom dosimetry was performed with a CC13 + F ionisation chamber to determine dose attenuation. Clinical validation included 15 patients undergoing hypofractionated GKRS. Cone-beam CT (CBCT) and High-Definition Motion Management (HDMM) were used for alignment and motion monitoring. Statistical comparison of motion parameters was performed using one-way ANOVA.

Results

Finite element analysis revealed a maximum von Mises stress of 10.36 MPa, well below PETG’s yield strength (53 MPa). Phantom testing showed a mean dose attenuation of 3.8%, confirming negligible influence on radiation accuracy. Clinical analysis demonstrated an average patient motion of 0.44 ± 0.22 mm, with only 40% of cases showing transient deviations beyond 1.5 mm. ANOVA indicated a significant difference in motion distribution among sessions (p = 0.041). Patients rated the frame as comfortable and non-intimidating, with no major skin reactions.

Conclusion

The PETG frame offers a reusable, non-invasive, and cost-effective immobilization alternative for GKRS. Its proven mechanical reliability, radiological transparency, and compatibility with CBCT and HDMM systems establish it as a sustainable advancement in modern radiosurgical head fixation technology.