Short-term safety and effectiveness of the mCLIP partial prosthesis

Rasse T, Niederwanger L, Hornung J, Taha L, Arndt S, Offergeld C, Beutner D, Bevis N, Lenarz T, Teschner M, Schimanski E, Georg Sprinzl , Magele A, Skarżyński PH, Plichta Ł, Arnoldner C, Riss D, Loader B, Windisch F, Rubicz N, Zwittag PM (2023)

Publication Type: Journal article

Publication year: 2023

Journal

European Archives of Oto-Rhino-Laryngology Springer

DOI: 10.1007/s00405-023-08359-1

Abstract

Purpose: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. Methods: Patients 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 (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). Results: 72 (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 PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. Conclusion: Clinical 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.

Authors with CRIS profile

Joachim Hornung Department of Otorhinolaryngology – Head and Neck Surgery Lava Taha Department of Otorhinolaryngology – Head and Neck Surgery

Involved external institutions

Clinic of the International Center of Hearing and Speech Medincus PL Poland (PL) Institute of Physiology and Pathology of Hearing PL Poland (PL) Medizinische Universität Wien AT Austria (AT) Kepler Universitätsklinikum (KUK) AT Austria (AT) Klinikum Wels-Grieskirchen AT Austria (AT) Universitätsklinikum Freiburg DE Germany (DE) Georg-August-Universität Göttingen DE Germany (DE) Medizinische Hochschule Hannover (MHH) / Hannover Medical School DE Germany (DE) Fachhochschule St. Pölten AT Austria (AT)

How to cite

APA:

Rasse, T., Niederwanger, L., Hornung, J., Taha, L., Arndt, S., Offergeld, C.,... Zwittag, P.M. (2023). Short-term safety and effectiveness of the mCLIP partial prosthesis. European Archives of Oto-Rhino-Laryngology. https://doi.org/10.1007/s00405-023-08359-1

MLA:

Rasse, Thomas, et al. "Short-term safety and effectiveness of the mCLIP partial prosthesis." European Archives of Oto-Rhino-Laryngology (2023).

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