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- Title
Short-term safety and effectiveness of the mCLIP partial prosthesis.
- Authors
Rasse, Thomas; Niederwanger, Lisa; Hornung, Joachim; Taha, Lava; Arndt, Susan; Offergeld, Christian; Beutner, Dirk; Bevis, Nicholas; Lenarz, Thomas; Teschner, Magnus; Schimanski, Esther; Georg Sprinzl; Magele, Astrid; Skarżyński, Piotr H.; Plichta, Łukasz; Arnoldner, Christoph; Riss, Dominik; Loader, Benjamin; Windisch, Franz; Rubicz, Nina
- 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.
- Subjects
PROSTHETICS; BONE conduction; TYMPANOPLASTY; EAR examination; AUDIOMETRY; MIDDLE ear
- Publication
European Archives of Oto-Rhino-Laryngology, 2024, Vol 281, Issue 5, p2353
- ISSN
0937-4477
- Publication type
Article
- DOI
10.1007/s00405-023-08359-1