Evidence map›Paper›PMID 31764794›Full record

Trial reportMedicine2019

A ball-slide-type interbody distractor is effective in posterior reduction and internal fixation for patients with mid- to high-grade isthmic spondylolisthesis enrolled in a randomized clinical trial.

Pengfei Li, Zongmao Zhao, Nan Jia, Litao Wang, Zhaosheng Sun, Xianhui Jin

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2019. 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
0.3field-weighted citation impact, top 38% 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.

  1. Article
  2. Article
  3. 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

6 authors at 2 institutions in 1 country.

Pengfei LiDepartment of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang.
Zongmao ZhaoDepartment of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang.
Nan JiaDepartment of Orthopaedics, Harrison International Peace Hospital of Hebei Medical University, Hengshui.
Litao WangDepartment of Orthopaedics, Harrison International Peace Hospital of Hebei Medical University, Hengshui.
Zhaosheng SunDepartment of Neurosurgery, Harrison International Peace Hospital of Hebei Medical University, Hengshui, Hebei, China.
Xianhui JinDepartment of Orthopaedics, Harrison International Peace Hospital of Hebei Medical University, Hengshui.
Harrison International Peace Hospital · CNHebei Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designClinical and radiographic results of a randomized, controlled, double-blind clinical trial

objective: To investigate the clinical applicability of a ball-point slide-type interbody distractor in posterior reduction and internal fixation for mid- to high-grade isthmic spondylolisthesis. SUMMARY OF BACKGROUND DATA: Posterior reduction and internal fixation is the effective treatment for spondylolisthesis. However, for the mid and high-grade isthmic spondylolisthesis patients with the conditions of vertebral osteoporosis and extremely narrow intervertebral space, the reduction is difficult; post-surgery intervertebral space height lost becomes serious; the fracture and loosening rate of fixation system is higher. No study regarding the prevention of these adverse outcomes in this technique is reported.

methodsA total of 59 patients of mid and high-grade isthmic spondylolisthesis were randomly divided into random groups (investigational group and control group) applying simple randomized method in this study. In addition, 30 patients received posterior reduction and internal fixation as control. Twenty-nine patients received posterior reduction and internal fixation by ball-point slide-type interbody distractor were assigned to the investigational group. X-ray examination was performed before and after operation. The degree of reduction, height of intervertebral space were compared. The preoperative and postoperative Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) were evaluated. Additionally, rate of the fixation system fracture was also assessed.

resultsBefore treatment, there were no significant differences in ISH (P = .72), DR (P = .85), VAS of back pain (P = .55), VAS of leg pain (P = .83) and ODI (P = .68) were found between 2 groups. After 12-month treatment, there were no significant differences in ISH (P = .26), VAS of back pain (P = .09) and VAS of leg pain (P = .96) between two groups. Significant differences of DR (P = .02), ODI (P = .03) and adverse events (P = .00) were found between 2 groups.

conclusionsThe results of this prospectively study showed that the ball-point slide-type interbody distractor in the posterior reduction and internal fixation produced good outcomes after 12-month treatment. More high quality randomized controlled trials and cases should still be needed to warrant the results of this study.

Indexed as

Orthopedic Fixation DevicesOrthopedic ProceduresDouble-Blind MethodEquipment DesignFemaleHumansMaleMiddle AgedProspective StudiesSeverity of Illness IndexSpondylolisthesis

Identifiers

PMID31764794
PMCPMC6882592
OpenAlexW2990479925

What OpenQuestion holds

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Registered trials

None linked

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.