Evidence map›Paper›PMID 35577757›Full record

ArticleJournal of Korean Neurosurgical Society2022

Safety and Efficacy of Bone Cement (Spinofill®) for Vertebroplasty in Patients with Osteoporotic Compression Fracture : A Preliminary Prospective Study.

Han Byeol Park, Seong Son, Jong Myung Jung, Sang Gu Lee, Byung Rhae Yoo

Open access · goldAbstract read
In one paragraph

Article in Journal of Korean Neurosurgical Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Incidence and predictors of residual back pain after percutaneous vertebral augmentation in osteoporotic vertebral compression fracture: a systematic review and meta analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Pooled it
  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

5 authors at 1 institution in 1 country.

Han Byeol ParkDepartment of Neurosurgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Seong SonDepartment of Neurosurgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Jong Myung JungDepartment of Neurosurgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Sang Gu LeeDepartment of Neurosurgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Byung Rhae YooDepartment of Neurosurgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Gachon University · KR

Funding

Gachon University Gil Medical Center FRD2020-15Ministry of Science and ICT 2021M3I2A1077405National Research Foundation of Korea
6 · The paper itself

Abstract

objectiveAlthough several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product.

methodsA prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph.

resultsThe pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end.

conclusionThe overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products.

Indexed as

Bone cementsCompression fracturePolymethyl methacrylateSpinofillVertebraVertebroplasty

Identifiers

PMID35577757
PMCPMC9452384
OpenAlexW4280565740

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.