A Novel Percutaneous Guide Wire (S-Wire) for Percutaneous Pedicle Screw Insertion

Its Development, Efficacy, and Safety

Ken Ishii, Yasuhito Kaneko, Haruki Funao, Shinichi Ishihara, Akira Shinohara, Kazuo Nakanishi, Tomohiro Hikata, Nobuyuki Fujita, Akio Iwanami, Naobumi Hosogane, Koota Watanabe, Takeo Nagura, Masaya Nakamura, Yoshiaki Toyama, Morio Matsumoto

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Purpose. Minimally invasive spine stabilization (MISt) procedures, including MIS-transforaminal lumbar interbody fusion (MIS-TLIF), rely on precise placement of percutaneous pedicle screws (PPS). Serious intraoperative complications associated with PPS placement include great vessel and bowel injuries due to the guide-wire's anterior migration and penetration through the anterior aspect of the vertebral body. To address this issue, we developed a novel percutaneous guide wire (S-wire) and compared the biomechanical characteristics of S-wire and conventional wire in cadaveric spines, and to evaluate the S-wire's efficacy and safety in a clinical trial. Methods. The S-wire is hollow, with braided wires extending at one tip. We compared the push-out and penetration forces of the S-wire and conventional wire in fresh cadaveric lumbar spines, from L1 to L5. Results. Push-out forces caused the braided tip of the S-wire to bend or spread, and thus to resist anterior migration. The mean push-out forces for the S-wire and conventional wire were 15.5 ± 1.9 and 5.7 ± 0.8 N, respectively (P <.0001); the mean penetration forces were 69.1 ± 4.2 and 37.1± 4.8 N, respectively (P <.0005). There was no wire breakage or anterior-wall penetration in a clinical trial of 922 S-wires; interestingly, the pull-out force increased in 780 (84.6%) S-wires after placement. Conclusions. The mean push-out and penetration forces for the S-wire were approximately 3 and 2 times greater than those of conventional wire, respectively. The S-wire effectively prevented guide-wire anterior migration and penetration of the anterior vertebral-body wall. The S-wire device should effectively improve the safety of MISt procedures, including MIS-TLIF and percutaneous kyphoplasty in selected patient with osteoporosis.

Original languageEnglish
Pages (from-to)469-473
Number of pages5
JournalSurgical Innovation
Volume22
Issue number5
DOIs
Publication statusPublished - 2015 Oct 22

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Spine
Safety
Clinical Trials
Kyphoplasty
Intraoperative Complications
Osteoporosis
Equipment and Supplies
Pedicle Screws
Wounds and Injuries

Keywords

  • Image-guided surgery
  • neurosurgery
  • spine surgery

ASJC Scopus subject areas

  • Surgery

Cite this

A Novel Percutaneous Guide Wire (S-Wire) for Percutaneous Pedicle Screw Insertion : Its Development, Efficacy, and Safety. / Ishii, Ken; Kaneko, Yasuhito; Funao, Haruki; Ishihara, Shinichi; Shinohara, Akira; Nakanishi, Kazuo; Hikata, Tomohiro; Fujita, Nobuyuki; Iwanami, Akio; Hosogane, Naobumi; Watanabe, Koota; Nagura, Takeo; Nakamura, Masaya; Toyama, Yoshiaki; Matsumoto, Morio.

In: Surgical Innovation, Vol. 22, No. 5, 22.10.2015, p. 469-473.

Research output: Contribution to journalArticle

Ishii, K, Kaneko, Y, Funao, H, Ishihara, S, Shinohara, A, Nakanishi, K, Hikata, T, Fujita, N, Iwanami, A, Hosogane, N, Watanabe, K, Nagura, T, Nakamura, M, Toyama, Y & Matsumoto, M 2015, 'A Novel Percutaneous Guide Wire (S-Wire) for Percutaneous Pedicle Screw Insertion: Its Development, Efficacy, and Safety', Surgical Innovation, vol. 22, no. 5, pp. 469-473. https://doi.org/10.1177/1553350614560271
Ishii, Ken ; Kaneko, Yasuhito ; Funao, Haruki ; Ishihara, Shinichi ; Shinohara, Akira ; Nakanishi, Kazuo ; Hikata, Tomohiro ; Fujita, Nobuyuki ; Iwanami, Akio ; Hosogane, Naobumi ; Watanabe, Koota ; Nagura, Takeo ; Nakamura, Masaya ; Toyama, Yoshiaki ; Matsumoto, Morio. / A Novel Percutaneous Guide Wire (S-Wire) for Percutaneous Pedicle Screw Insertion : Its Development, Efficacy, and Safety. In: Surgical Innovation. 2015 ; Vol. 22, No. 5. pp. 469-473.
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abstract = "Purpose. Minimally invasive spine stabilization (MISt) procedures, including MIS-transforaminal lumbar interbody fusion (MIS-TLIF), rely on precise placement of percutaneous pedicle screws (PPS). Serious intraoperative complications associated with PPS placement include great vessel and bowel injuries due to the guide-wire's anterior migration and penetration through the anterior aspect of the vertebral body. To address this issue, we developed a novel percutaneous guide wire (S-wire) and compared the biomechanical characteristics of S-wire and conventional wire in cadaveric spines, and to evaluate the S-wire's efficacy and safety in a clinical trial. Methods. The S-wire is hollow, with braided wires extending at one tip. We compared the push-out and penetration forces of the S-wire and conventional wire in fresh cadaveric lumbar spines, from L1 to L5. Results. Push-out forces caused the braided tip of the S-wire to bend or spread, and thus to resist anterior migration. The mean push-out forces for the S-wire and conventional wire were 15.5 ± 1.9 and 5.7 ± 0.8 N, respectively (P <.0001); the mean penetration forces were 69.1 ± 4.2 and 37.1± 4.8 N, respectively (P <.0005). There was no wire breakage or anterior-wall penetration in a clinical trial of 922 S-wires; interestingly, the pull-out force increased in 780 (84.6{\%}) S-wires after placement. Conclusions. The mean push-out and penetration forces for the S-wire were approximately 3 and 2 times greater than those of conventional wire, respectively. The S-wire effectively prevented guide-wire anterior migration and penetration of the anterior vertebral-body wall. The S-wire device should effectively improve the safety of MISt procedures, including MIS-TLIF and percutaneous kyphoplasty in selected patient with osteoporosis.",
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T2 - Its Development, Efficacy, and Safety

AU - Ishii, Ken

AU - Kaneko, Yasuhito

AU - Funao, Haruki

AU - Ishihara, Shinichi

AU - Shinohara, Akira

AU - Nakanishi, Kazuo

AU - Hikata, Tomohiro

AU - Fujita, Nobuyuki

AU - Iwanami, Akio

AU - Hosogane, Naobumi

AU - Watanabe, Koota

AU - Nagura, Takeo

AU - Nakamura, Masaya

AU - Toyama, Yoshiaki

AU - Matsumoto, Morio

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N2 - Purpose. Minimally invasive spine stabilization (MISt) procedures, including MIS-transforaminal lumbar interbody fusion (MIS-TLIF), rely on precise placement of percutaneous pedicle screws (PPS). Serious intraoperative complications associated with PPS placement include great vessel and bowel injuries due to the guide-wire's anterior migration and penetration through the anterior aspect of the vertebral body. To address this issue, we developed a novel percutaneous guide wire (S-wire) and compared the biomechanical characteristics of S-wire and conventional wire in cadaveric spines, and to evaluate the S-wire's efficacy and safety in a clinical trial. Methods. The S-wire is hollow, with braided wires extending at one tip. We compared the push-out and penetration forces of the S-wire and conventional wire in fresh cadaveric lumbar spines, from L1 to L5. Results. Push-out forces caused the braided tip of the S-wire to bend or spread, and thus to resist anterior migration. The mean push-out forces for the S-wire and conventional wire were 15.5 ± 1.9 and 5.7 ± 0.8 N, respectively (P <.0001); the mean penetration forces were 69.1 ± 4.2 and 37.1± 4.8 N, respectively (P <.0005). There was no wire breakage or anterior-wall penetration in a clinical trial of 922 S-wires; interestingly, the pull-out force increased in 780 (84.6%) S-wires after placement. Conclusions. The mean push-out and penetration forces for the S-wire were approximately 3 and 2 times greater than those of conventional wire, respectively. The S-wire effectively prevented guide-wire anterior migration and penetration of the anterior vertebral-body wall. The S-wire device should effectively improve the safety of MISt procedures, including MIS-TLIF and percutaneous kyphoplasty in selected patient with osteoporosis.

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KW - neurosurgery

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