Evidence map›Paper›PMID 39001922›Full record

ArticleEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2024

Safety and performance of the new med-el total ossicular replacement prostheses.

Esther Schimanski, Thomas Lenarz, Susan Busch, Susan Arndt, Christian Offergeld, Christoph Arnoldner, Dominik Riss, Joachim Hornung, Lava Taha, Paul Martin Zwittag and 11 more

Registry-linked trialAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05565339 (PMEI Post-Market Clinical Follow-Up), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT05565339 completednot on this map

PMEI Post-Market Clinical Follow-Up

TypeobservationalSponsorMED-EL Elektromedizinische Geräte GesmbHRan2020 to 2023Enrolled497ConditionsPre-existing ConditionArmsPMEIs
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Esther Schimanski *ENT Practice, Zentrum fuer Mittelohrchirurgie (Centre for Middle Ear Surgery), 44536, Luenen, Germany. e.schimanski@mittelohr.de.ORCID http://orcid.org/0009-0001-8581-4649
Thomas Lenarz *Department of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
Susan BuschDepartment of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
Susan ArndtDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center-University Of Freiburg, University of Freiburg, 79106, Freiburg, Germany.
Christian OffergeldDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center-University Of Freiburg, University of Freiburg, 79106, Freiburg, Germany.
Christoph ArnoldnerDepartment of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.
Dominik RissDepartment of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.
Joachim HornungDepartment of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.
Lava TahaDepartment of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.
Paul Martin ZwittagDepartment of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, 4020, Linz, Austria.
Nina RubiczDepartment of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, 4020, Linz, Austria.
Dirk BeutnerDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Göttingen, 37075, Göttingen, Germany.
Nicholas BevisDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Göttingen, 37075, Göttingen, Germany.
Benjamin LoaderDepartment of Otorhinolaryngology, Head and Neck Surgery, 1030 Wiener Gesundheitsverbund, Klinik Landstraße, 1030, Vienna, Austria.
Franz WindischDepartment of Otorhinolaryngology, Head and Neck Surgery, 1030 Wiener Gesundheitsverbund, Klinik Landstraße, 1030, Vienna, Austria.
Georg SprinzlUniversity Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, 3100, St. Pölten, Austria.
Astrid MageleUniversity Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, 3100, St. Pölten, Austria.
Wendelin WolframDepartment of Otorhinolaryngology-Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Lisa NiederwangerDepartment of Otorhinolaryngology-Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Łukasz PlichtaCenter of Hearing and Speech MEDINCUS, Clinical Trials Department, Kajetany, Poland.
Piotr H SkarżyńskiCenter of Hearing and Speech MEDINCUS, Clinical Trials Department, Kajetany, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP).

methodsPatients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA

results103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. ADVERSE EVENTS RESULTS (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. AUDIOLOGICAL RESULTS (N = 92): 49 (53.3%) of the 92 patients had a PTA

conclusionThe MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.

Indexed as

Audiometry, Pure-ToneOssicular ProsthesisOssicular ReplacementTympanoplastyAdolescentAdultAgedChildChild, PreschoolFemaleHumansMaleMiddle AgedPostoperative ComplicationsProsthesis DesignRetrospective StudiesHearing restorationmXACT PRO Total ProsthesismXACT Total Prosthesis CentermXACT Total Prosthesis OffcenterTotal ossicular replacement prosthesesTympanoplasty type 3

Identifiers

PMID39001922

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Registered trials

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