Evidence map›Paper›PMID 31351477›Full record

Trial reportJournal of orthopaedic surgery and research2019

Properties and clinical application safety of antibiotic-loaded bone cement in kyphoplasty.

Maciej Opalko, Hans Bösebeck, Sebastian Vogt

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Journal of orthopaedic surgery and research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
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  5. Review
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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

3 authors at 1 institution in 1 country.

Maciej OpalkoKlinik für Orthopädie und Unfallchirurgie, Kreiskrankenhaus Prenzlau, Prenzlau, Germany.
Hans BösebeckHeraeus Medical GmbH, Medical Affairs, Philipp-Reis-Str. 8/13, 61273, Wehrheim, Germany. hans.boesebeck@heraeus.com.ORCID http://orcid.org/0000-0003-0463-2411
Sebastian VogtHeraeus Medical GmbH, Innovation, Philipp-Reis-Str. 8/13, 61273, Wehrheim, Germany.
Heraeus (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence on antibiotic-loaded bone cement remains too vague to guide kyphoplasty in patient care. We clinically evaluated the properties and benefits of a new low viscosity polymethylmethacrylate (PMMA) bone cement loaded with gentamicin.

methodsIn this non-randomised, monocentric, prospective open trial, 50 consecutively enrolled patients with fractures of the vertebral body (TH7-L4) due to osteoporosis or trauma were investigated between 2010 and 2013, with a 1-year post-op follow-up per patient. The antibiotic-loaded PMMA bone cement was administered to patients during the surgery according to the standard procedure established on site for one-staged kyphoplasty. The clinical outcome was assessed according to function and pain by standardised anamnesis, clinical investigation, validated visual analogue scale (VAS) vertebral spine score, Oswestry Low-Back-Pain (ODI) Disability score, and Short Form (SF)-36 score. We further performed X-ray and magnetic resonance imaging with radiomorphometric assessment.

resultsThe patients showed beneficial effects concerning low back pain disability (mean ODI score; screening, 68.0 ± 15.8% vs month 12, 42.8 ± 24.5%). The pain level was decreased (VAS vertebral spine score; screening, 68.8 ± 17.6 vs month 12, 43.8 ± 22.2) and the general health state was improved (SF-36; especially 'role limitations due to emotional problems' (51.9 ± 44.7; month 6), followed by 'role limitations due to physical health' (36.1 ± 42.4; month 6), and 'pain' (34.6 ± 35.3; month 6)). No vertebral infection did occur during the hospital stay or the 1-year follow-up. The stabilisation and restoration of the fractured bodies were radiologically confirmed. A reduced rate of leakage was observed, combined with a decreased risk of infection and an improved patient safety after a 1-year follow-up period.

conclusionRequirements for bone cement in a kyphoplasty setting were excellently fulfilled. Application technique and cement properties may influence the success of the surgery.

trial registrationDeutsche Institut für Medizinische Dokumentation und Information (DIMDI), HM-KS-0901, Registered 14 September 2009, https://www.dimdi.de/dynamic/de/medizinprodukte/datenbankrecherche/.

Indexed as

AgedAnti-Bacterial AgentsBone CementsFemaleFollow-Up StudiesHumansKyphoplastyLumbar VertebraeMaleMiddle AgedPolymethyl MethacrylateProspective StudiesSpinal FracturesThoracic VertebraeAnti-Bacterial AgentsBone CementsPolymethyl MethacrylateAntibiotic-loaded bone cement (ALBC)GentamicinKyphoplastyLocal antibiotic treatmentLow viscosity cementOsteopal GPMMA

Identifiers

PMID31351477
PMCPMC6660699
OpenAlexW2965638516

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.