Evidence map›Paper›PMID 35634131›Full record

ArticleNorth American Spine Society journal2022

Accuracy and safety of percutaneous pedicle screw placement using the K-wireless minimally invasive spine percutaneous pedicle screw system in Japan: A randomized active controlled study.

Kazuo Ohmori, Sei Terayama, Koichiro Ono, Miyuki Sakamoto, Yukie Horikoshi

Open access · goldAbstract read
In one paragraph

Article in North American Spine Society journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Kazuo OhmoriCenter for Spinal Surgery, Nippon Koukan Hospital, 1-2-1 Koukandori, Kawasaki-ku, Kawasaki, Kanagawa, Japan.
Sei TerayamaDepartment of Orthopedic Surgery, Shunyokai Central Hospital, 485 Niitomi, Kimotuki-cho, Kimotuki-gun, Kagoshima, Japan.
Koichiro OnoCenter for Spinal Surgery, Nippon Koukan Hospital, 1-2-1 Koukandori, Kawasaki-ku, Kawasaki, Kanagawa, Japan.
Miyuki SakamotoJohnson and Johnson K.K, Medical Company, 3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan.
Yukie HorikoshiJohnson and Johnson K.K, Medical Company, 3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Minimally invasive lumbar fusion has recently become a widely used technique worldwide. This randomized active controlled study was conducted to demonstrate the non-inferiority of the K-wireless Minimally Invasive Spine (MIS) Percutaneous Pedicle Screw (PPS) system compared with use of the six pedicle screw systems currently used in our practices with respect to the accuracy of pedicle screw placement.Also to compare the screw-insertion time and number of fluoroscopic observations during screw insertion between the groups. Methods: A total of 80 patients with degenerative spinal diseases or vertebral fractures were assigned, including 41 patients in the K-wireless MIS PPS system group (K-wireless group) and 39 in the control group (K-wire group).The accuracy of the screw insertion, screw-insertion time, number of fluoroscopic observations during screw insertion, and the incidence of adverse events were compared between the K-wireless group and the K-wire group. The accuracy rate was calculated as the number of screws with no breach divided by the total number of screws. Results: The accuracy rates of screw insertion were 85.7% and 75.0% in the K-wireless and K-wire groups, respectively, with an intergroup difference of 10.7% (95% confidence interval: 2.3-19.1%). The K-wireless group demonstrated non-inferiority compared with the K-wire group. The mean screw-insertion time was significantly shorter in the K-wireless group (2.62 and 2.97 min in the K-wireless and K-wire groups, respectively; Conclusions: The accuracy of pedicle screw insertion using the K-wireless MIS PPS system was not inferior to that of existing products. In terms of safety, no product-related or treatment-related adverse events were identified in this study and no new safety concerns were noted.

Indexed as

Accuracy of screw insertionK-wireless MIS PPS systemMinimally Invasive SpinePercutaneous Pedicle ScrewPPSRandomized controlled trial

Identifiers

PMID35634131
PMCPMC9130105
OpenAlexW4229333395

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.