Evidence map›Paper›PMID 25005841›Full record

ArticleBone & joint research2014

Clinical use and safety of a novel gentamicin-releasing resorbable bone graft substitute in the treatment of osteomyelitis/osteitis.

N Fleiter, G Walter, H Bösebeck, S Vogt, H Büchner, W Hirschberger, R Hoffmann

Open access · goldAbstract read
In one paragraph

Article in Bone & joint research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
6.7field-weighted citation impact, top 3% 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

36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 70 citations in OpenAlex.

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  14. Use of contemporary biomaterials in chronic osteomyelitis treatment: Clinical lessons learned and literature review.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2021
    Review
  15. Treatment of Stage 2 Medication-Induced Osteonecrosis of the Jaw: A Case Series.International journal of environmental research and public health · 2021
    Article
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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

7 authors at 2 institutions in 1 country.

N FleiterBerufsgenossenschaftliche Unfallklinik, Friedberger Landstraße 430, 60389, Frankfurt, Germany.
G WalterBerufsgenossenschaftliche Unfallklinik, Friedberger Landstraße 430, 60389, Frankfurt, Germany.
H BösebeckHeraeus Medical, Philipp-Reiss-Strasse 8/13, 61273 Wehrheim, Germany.
S VogtHeraeus Medical, Philipp-Reiss-Strasse 8/13, 61273 Wehrheim, Germany.
H BüchnerHeraeus Medical, Philipp-Reiss-Strasse 8/13, 61273 Wehrheim, Germany.
W HirschbergerFacharztpraxis Chirurgie-Maintaunus, Dr. Enderle, Hirschberger & Partner, Waldstraße 9, 65812 Bad Soden, Germany.
R HoffmannBerufsgenossenschaftliche Unfallklinik, Friedberger Landstraße 430, 60389, Frankfurt, Germany.
Berufsgenossenschaftliche Unfallklinik Frankfurt am Main · DEHeraeus (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA clinical investigation into a new bone void filler is giving first data on systemic and local exposure to the anti-infective substance after implantation.

methodA total of 20 patients with post-traumatic/post-operative bone infections were enrolled in this open-label, prospective study. After radical surgical debridement, the bone cavity was filled with this material. The 21-day hospitalisation phase included determination of gentamicin concentrations in plasma, urine and wound exudate, assessment of wound healing, infection parameters, implant resorption, laboratory parameters, and adverse event monitoring. The follow-up period was six months.

resultsSystemic exposure to gentamicin after implantation was very low as local gentamicin concentrations were measured in wound exudate after six to ten hours. There were no signs of infectious complication throughout the clinical phase. Four patients had recurrent infections several weeks to months after implantation. The outcome was deemed successful by remission of infection in 16 (80%) of these problematic long-term treated patients. Safety laboratory measurements did not indicate nephrotoxic or hepatotoxic effects.

conclusionsLocal application of calcium sulphate/carbonate bone void filler comprising gentamicin revealed sufficient active local levels of the antibiotic by simultaneous significant low systemic exposure in patients with mostly chronic osteomyelitis/osteitis. The material was safe and well tolerated. Cite this article: Bone Joint Res 2014;3:223-9.

Indexed as

Calcium sulfateGentamicinLocal antibiotic therapyOsteomyelitisResorbable bone void filler

Identifiers

PMID25005841
PMCPMC4112779
OpenAlexW2121069945

What OpenQuestion holds

Textmetadata
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.