Evidence map›Paper›PMID 38133806›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

Short-term safety and effectiveness of the mCLIP partial prosthesis.

Thomas Rasse, Lisa Niederwanger, Joachim Hornung, Lava Taha, Susan Arndt, Christian Offergeld, Dirk Beutner, Nicholas Bevis, Thomas Lenarz, Magnus Teschner and 11 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
PubMed Full text at PMC 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. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 27% 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.

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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Multicenter study results of the med-el partial ossicular replacement prostheses.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 · 2026
    Article
  2. Short-term audiological outcomes of the mCLIP ARC ball joint prosthesis- a retrospective multicenter study.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 · 2025
    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

21 authors at 11 institutions in 3 countries.

Thomas RasseDepartment of Otorhinolaryngology, Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Lisa NiederwangerDepartment of Otorhinolaryngology, Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Joachim HornungDepartment of Otorhinolaryngology, Head and Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.
Lava TahaDepartment of Otorhinolaryngology, Head and Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.
Susan ArndtDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center, University of Freiburg, 79106, Freiburg, Germany.
Christian OffergeldDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center, University of Freiburg, 79106, Freiburg, Germany.
Dirk BeutnerDepartment of Otolaryngology, University of Goettingen, 37075, Göttingen, Germany.
Nicholas BevisDepartment of Otolaryngology, University of Goettingen, 37075, Göttingen, Germany.
Thomas LenarzDepartment of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
Magnus TeschnerDepartment of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
Esther SchimanskiZentrum Fuer Mittelohrchirurgie (Centre for Middle Ear Surgery), ENT Practice, 44536, Luenen, Germany.
Georg SprinzlDepartment of Otorhinolaryngology, Head and Neck Surgery, University Clinic St. Poelten, 3100, St. Pölten, Austria.
Astrid MageleDepartment of Otorhinolaryngology, Head and Neck Surgery, University Clinic St. Poelten, 3100, St. Pölten, Austria.
Piotr H SkarżyńskiClinical Trials Department, Center of Hearing and Speech MEDINCUS, Kayetany, Poland.
Łukasz PlichtaWorld Hearing Center of the Institute of Physiology and Pathology of Hearing, Kajetany, Poland.
Christoph ArnoldnerDepartment of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.
Dominik RissDepartment of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.
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.
Nina RubiczDepartment of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, Krankenhausstrasse 9, 4020, Linz, Austria.
Paul Martin ZwittagDepartment of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, Krankenhausstrasse 9, 4020, Linz, Austria. paulmartin.zwittag@kepleruniklinikum.at.ORCID http://orcid.org/0000-0002-8656-8400
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEJohannes Kepler University of Linz · ATKlinikum Wels-Grieskirchen · ATMedical University of Vienna · ATMedizinische Hochschule Hannover · DEUniversity of Applied Sciences St Pölten · ATUniversity of Freiburg · DEUniversity of Göttingen · DEWiener Krankenanstaltenverbund · ATInstitute of Physiology and Pathology of Hearing · PLMedical University of Warsaw · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis.

methodsPatients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included 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

results72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA

conclusionClinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. TRIAL REGISTRATION NUMBER: NCT05565339, 09 September 2022, retrospectively registered.

Indexed as

Ossicular ProsthesisAdultAudiometry, Pure-ToneBone ConductionChildFollow-Up StudiesHumansProsthesis ImplantationRetrospective StudiesTreatment OutcomeHearing restorationmCLIP partial prosthesisOssiculoplastyPassive middle ear implant

Identifiers

PMID38133806
PMCPMC11024005
OpenAlexW4390113892

What OpenQuestion holds

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Registered trials

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.