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; Esther Schimanski; Georg  Sprinzl; Astrid Magele; Piotr H Skarżyński; Łukasz Plichta; Christoph Arnoldner; Dominik Riss; Benjamin Loader; Franz Windisch; Nina Rubicz; Paul Martin Zwittag

doi:10.1007/s00405-023-08359-1

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, Esther Schimanski, Georg Sprinzl, Astrid Magele, Piotr H Skarżyński, Łukasz Plichta, Christoph Arnoldner, Dominik Riss, Benjamin Loader, Franz Windisch, Nina RubiczPaul Martin Zwittag

Division of Otorhinolaryngology (University Hospital St. Pölten)

Research output: Journal article (peer-reviewed) › Journal article

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.

Original language	English
Pages (from-to)	2353-2363
Number of pages	11
Journal	European Archives of Oto-Rhino-Laryngology
Volume	281
Issue number	5
DOIs	https://doi.org/10.1007/s00405-023-08359-1
Publication status	E-pub ahead of print - 22 Dec 2023

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Rasse, T., Niederwanger, L., Hornung, J., Taha, L., Arndt, S., Offergeld, C., Beutner, D., Bevis, N., Lenarz, T., Teschner, M., Schimanski, E., Sprinzl, G., Magele, A., Skarżyński, P. H., Plichta, Ł., Arnoldner, C., Riss, D., Loader, B., Windisch, F., ... Zwittag, P. M. (2023). Short-term safety and effectiveness of the mCLIP partial prosthesis. European Archives of Oto-Rhino-Laryngology, 281(5), 2353-2363. Advance online publication. https://doi.org/10.1007/s00405-023-08359-1

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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.",

author = "Thomas Rasse and Lisa Niederwanger and Joachim Hornung and Lava Taha and Susan Arndt and Christian Offergeld and Dirk Beutner and Nicholas Bevis and Thomas Lenarz and Magnus Teschner and Esther Schimanski and Georg Sprinzl and Astrid Magele and Skar{\.z}y{\'n}ski, {Piotr H} and {\L}ukasz Plichta and Christoph Arnoldner and Dominik Riss and Benjamin Loader and Franz Windisch and Nina Rubicz and Zwittag, {Paul Martin}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2023.",

year = "2023",

month = dec,

day = "22",

doi = "10.1007/s00405-023-08359-1",

language = "English",

volume = "281",

pages = "2353--2363",

journal = "European Archives of Oto-Rhino-Laryngology",

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Rasse, T, Niederwanger, L, Hornung, J, Taha, L, Arndt, S, Offergeld, C, Beutner, D, Bevis, N, Lenarz, T, Teschner, M, Schimanski, E, Sprinzl, G , Magele, A, Skarżyński, PH, Plichta, Ł, Arnoldner, C, Riss, D, Loader, B, Windisch, F, Rubicz, N & Zwittag, PM 2023, 'Short-term safety and effectiveness of the mCLIP partial prosthesis', European Archives of Oto-Rhino-Laryngology, vol. 281, no. 5, pp. 2353-2363. https://doi.org/10.1007/s00405-023-08359-1

TY - JOUR

T1 - Short-term safety and effectiveness of the mCLIP partial prosthesis

AU - Rasse, Thomas

AU - Niederwanger, Lisa

AU - Hornung, Joachim

AU - Taha, Lava

AU - Arndt, Susan

AU - Offergeld, Christian

AU - Beutner, Dirk

AU - Bevis, Nicholas

AU - Lenarz, Thomas

AU - Teschner, Magnus

AU - Schimanski, Esther

AU - Sprinzl, Georg

AU - Magele, Astrid

AU - Skarżyński, Piotr H

AU - Plichta, Łukasz

AU - Arnoldner, Christoph

AU - Riss, Dominik

AU - Loader, Benjamin

AU - Windisch, Franz

AU - Rubicz, Nina

AU - Zwittag, Paul Martin

PY - 2023/12/22

Y1 - 2023/12/22

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85180190646&partnerID=8YFLogxK

U2 - 10.1007/s00405-023-08359-1

DO - 10.1007/s00405-023-08359-1

M3 - Journal article

C2 - 38133806

SN - 0937-4477

VL - 281

SP - 2353

EP - 2363

JO - European Archives of Oto-Rhino-Laryngology

JF - European Archives of Oto-Rhino-Laryngology

IS - 5

ER -

Short-term safety and effectiveness of the mCLIP partial prosthesis

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