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Objective <p>To evaluate the feasibility of spondyloplasty with SpineJack<sup>®</sup> implants in patients with thin vertebral pedicles, outside the manufacturer’s recommendation.</p> Materials and methods <p>In this retrospective bicentric study, all patients treated with spondyloplasty using SpineJack<sup>®</sup> implants for traumatic, porotic or malignant vertebral compression fractures were enrolled. Pedicle diameter was assessed to classify patients into the “Thin Pedicle” (TP) group, outside the manufacturer’s recommendation (&lt; 5 mm and/or safety margin &lt; 0.8 mm between implant and pedicle), or into the “Advised Pedicle Size“ (APS) group. The primary outcome was correct implant positioning on postoperative imaging. Secondary outcomes included restoration of vertebral height, procedure duration, radiation dose, hospital stay, and complications.</p> Results <p>A total of 148 patients (mean age 49 ± 37 years ; 55% of male) underwent 151 spondyloplasties: 51 in the TP group and 100 in the APS group. Correct implant positioning was achieved in all procedures in both groups (100%). There was no significant difference in vertebral height restoration (81% vs. 71%; <i>p</i> = 0.058). Radiation exposure was significantly lower in the TP group (<i>p</i> = 0.02), while procedure duration and hospital stay were comparable, with 55% of procedures performed on an outpatient basis. Complication rates did not differ significantly, consisting mostly of cement leakages (20% vs. 19%; <i>p</i> = 0.93).</p> Conclusion <p>Spondyloplasty with SpineJack<sup>®</sup> implants under radiological guidance appears feasible and safe in patients with thin pedicles, even when the pedicle size is below the manufacturer’s suggested threshold.</p> Key Points <p><Emphasis Type="BoldItalic">Question</Emphasis><i> Does pedicle size below recommended thresholds affect procedural feasibility, safety, and clinical outcomes when performing SpineJack® implantation under radiological guidance?</i></p> <p><Emphasis Type="BoldItalic">Findings</Emphasis><i> SpineJack® implantation achieved 100% correct positioning in thin pedicles, with complication rates, procedure duration, and hospital stay comparable to standard pedicle sizes</i>.</p> <p><Emphasis Type="BoldItalic">Clinical relevance</Emphasis><i> These findings support expanding SpineJack® indications to patients with narrow pedicles, increasing access to safe and efficient minimally invasive vertebral fracture treatment for a broader patient population</i>.</p> Graphical Abstract <p></p>

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Feasibility of spondyloplasty with SpineJack® implants in patients with thin vertebral pedicles

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Marion Bouchet,
  • Jean-Baptiste Pialat,
  • Bastien Chalamet,
  • William Boulade,
  • Charles Mayard,
  • Adrian Kastler,
  • Sylvain Grange,
  • Nicolas Stacoffe

摘要

Objective

To evaluate the feasibility of spondyloplasty with SpineJack® implants in patients with thin vertebral pedicles, outside the manufacturer’s recommendation.

Materials and methods

In this retrospective bicentric study, all patients treated with spondyloplasty using SpineJack® implants for traumatic, porotic or malignant vertebral compression fractures were enrolled. Pedicle diameter was assessed to classify patients into the “Thin Pedicle” (TP) group, outside the manufacturer’s recommendation (< 5 mm and/or safety margin < 0.8 mm between implant and pedicle), or into the “Advised Pedicle Size“ (APS) group. The primary outcome was correct implant positioning on postoperative imaging. Secondary outcomes included restoration of vertebral height, procedure duration, radiation dose, hospital stay, and complications.

Results

A total of 148 patients (mean age 49 ± 37 years ; 55% of male) underwent 151 spondyloplasties: 51 in the TP group and 100 in the APS group. Correct implant positioning was achieved in all procedures in both groups (100%). There was no significant difference in vertebral height restoration (81% vs. 71%; p = 0.058). Radiation exposure was significantly lower in the TP group (p = 0.02), while procedure duration and hospital stay were comparable, with 55% of procedures performed on an outpatient basis. Complication rates did not differ significantly, consisting mostly of cement leakages (20% vs. 19%; p = 0.93).

Conclusion

Spondyloplasty with SpineJack® implants under radiological guidance appears feasible and safe in patients with thin pedicles, even when the pedicle size is below the manufacturer’s suggested threshold.

Key Points

Question Does pedicle size below recommended thresholds affect procedural feasibility, safety, and clinical outcomes when performing SpineJack® implantation under radiological guidance?

Findings SpineJack® implantation achieved 100% correct positioning in thin pedicles, with complication rates, procedure duration, and hospital stay comparable to standard pedicle sizes.

Clinical relevance These findings support expanding SpineJack® indications to patients with narrow pedicles, increasing access to safe and efficient minimally invasive vertebral fracture treatment for a broader patient population.

Graphical Abstract