Evidence map›Paper›PMID 36289500›Full record

Trial reportBMC surgery2022

A novel surgical technique in transforaminal lumbar interbody fusion by the bone graft delivery device: evaluation of therapeutic effect in patients with minimally invasive spine surgery.

Kai-Shun Yang, Chih-Wei Chen, Ru-Bin Yau, Huang-Chien Liang, Ching-Chung Ko, Jinn-Rung Kuo, Chung-Ching Chio, Sher-Wei Lim

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05190055 (Department of Neurosurgery, Chi-Mei Medical Center), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 37% 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.

NCT05190055 naunknown statusnot on this map

Department of Neurosurgery, Chi-Mei Medical Center

TypeinterventionalSponsorChi Mei Medical HospitalRan2015 to 2023Enrolled73ConditionsSpinal FusionArmsbone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system, wiltrom interbody fusion system/wiltrom spinal fixation system
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
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

8 authors at 4 institutions in 3 countries.

Kai-Shun YangDepartment of Spinal Surgery, First Affiliated Hospital of Dali University, Dali, Yunnan, China.
Chih-Wei ChenDivision of Neurosurgery, Department of Surgery, Chi Mei Medical Center, Tainan City, 710, Taiwan.
Ru-Bin YauDepartment of Spinal Surgery, First Affiliated Hospital of Dali University, Dali, Yunnan, China.
Huang-Chien LiangDepartment of Materials Engineering, Ming Chi University of Technology, New Taipei City, Taiwan.
Ching-Chung KoDepartment of Medical Imaging, Chi-Mei Medical Center, Tainan City, Taiwan.
Jinn-Rung KuoDivision of Neurosurgery, Department of Surgery, Chi Mei Medical Center, Tainan City, 710, Taiwan.
Chung-Ching ChioDivision of Neurosurgery, Department of Surgery, Chi Mei Medical Center, Tainan City, 710, Taiwan.
Sher-Wei LimDivision of Neurosurgery, Department of Surgery, Chi Mei Medical Center, Tainan City, 710, Taiwan. slsw0219@gmail.com.
Chi Mei Medical Center · TWDali University · CNInstitute of Occupational Safety · SIMing Chi University of Technology · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransforaminal Lumbar Interbody Fusion (TLIF) is commonly associated with higher complications and longer operative time. This study aims to evaluate the effectiveness, safety, and usability of a novel minimally invasive surgery (MIS) bone graft delivery device.

methods73 consecutive patients with lumbar spondylosis, degenerative disc disease, spondylolisthesis, scoliosis or trauma were enrolled in this randomized controlled trial. Group 1 comprised 39 patients treated with the novel MIS bone graft delivery device. Group 2 consisted of 34 patients treated with the conventional system. The primary objective of the study was the assessment of the amount of bone graft delivery using the device. The secondary objectives were the effect of the device on operative time, pain relief, disability improvement, and bone fusion grade.

resultsBone delivery amount was significantly higher in the MIS device group (6.7 ± 2.9 mL) compared to the conventional group (2.3 ± 0.5 mL), p < 0.001. Regarding the operation time, the MIS device group was associated significantly lower duration than the conventional group (p < 0.001). After a 3-month follow-up, 39.5% of the patients in the MIS device group and 3.5% of the patients in the conventional group were observed to achieve grade I fusion (complete fusion). There was a significant difference in fusion success rates (p < 0.01).

conclusionThe novel MIS bone graft delivery device was associated with successful bone delivery. Our MIS device provides promising modality with less operative time and higher bone fusion rates than conventional modalities. Trial Registration This trial was retrospectively registered on ClinicalTrials.gov (Registration date: 11/19/2021; Registration number: NCT05190055).

Indexed as

Spinal FusionSpondylolisthesisHumansLumbar VertebraeMinimally Invasive Surgical ProceduresOperative TimeRetrospective StudiesTreatment OutcomeBone fusionBone graftMinimally invasive surgeryMIS device

Identifiers

PMID36289500
PMCPMC9597986
OpenAlexW4307561044

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.