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- Title
A Novel Percutaneous Guide Wire (S-Wire) for Percutaneous Pedicle Screw Insertion: Its Development, Efficacy, and Safety.
- Authors
Ishii, Ken; Kaneko, Yasuhito; Funao, Haruki; Ishihara, Shinichi; Shinohara, Akira; Nakanishi, Kazuo; Hikata, Tomohiro; Fujita, Nobuyuki; Iwanami, Akio; Hosogane, Naobumi; Watanabe, Kota; Nagura, Takeo; Nakamura, Masaya; Toyama, Yoshiaki; Matsumoto, Morio
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
LUMBAR vertebrae surgery; BONE screws; ORTHOPEDIC implants; ORTHOPEDIC surgery; PRODUCT design; EQUIPMENT &; supplies
- Publication
Surgical Innovation, 2015, Vol 22, Issue 5, p469
- ISSN
1553-3506
- Publication type
journal article
- DOI
10.1177/1553350614560271