PMID- 38265185 OWN - NLM STAT- Publisher LR - 20240124 IS - 1531-4995 (Electronic) IS - 0023-852X (Linking) DP - 2024 Jan 24 TI - Partial Ossicular Reconstruction With a Novel Ball Joint Prosthesis: The mCLIP ARC Partial Prosthesis. LID - 10.1002/lary.31301 [doi] AB - OBJECTIVE: Middle ear surgery involves reconstruction of the ossicular chain, predominately using rigid implants. New middle ear prostheses strive to mimic the physiologic micromovements of the ossicular chain and prevent dislocation, protrusion, and preloading of the annular ligament due to pressure fluctuations. METHODS: Thirty-five patients were included in a monocentric, prospective observational study. Patients received tympanoplasty with ossicular reconstruction using the mCLIP ARC partial prosthesis. This titanium prosthesis is equipped with a clip mechanism for coupling at the stapes and a ball joint connecting headplate and shaft. At short-term (ST) and mid-term (MT) follow-up, pure-tone audiometry was performed and the pure tone average of 0.5, 1, 2, and 3 kHz (PTA4) was calculated. The audiological outcome was compared with retrospective data of the Dresden titanium clip prosthesis. RESULTS: The new prosthesis shows favorable clinical results. Pure-tone audiometry showed satisfactory results in ST and MT follow-up, with the PTA4 air-bone gap (ABG) decreasing from 24.5 (+/-11) dB to 17.4 (+/-7.9) dB at the ST follow-up at 27 days to 15.6 (+/-10.3) dB at MT follow-up at 196 days (n = 32). A PTA4-ABG value of less than 20 dB was achieved by 63% of patients at ST follow-up and by 77% at MT follow-up. There was no significant difference in PTA4 ABG compared to the Dresden titanium clip prosthesis during ST follow-up (p = 0.18). CONCLUSION: The mCLIP ARC partial prosthesis, a new middle ear prosthesis with a balanced ball joint, shows promising audiological results and is a safe and effective choice for patients with chronic ear disease. LEVEL OF EVIDENCE: 3 Laryngoscope, 2024. CI - (c) 2024 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc. FAU - Bevis, Nicholas AU - Bevis N AUID- ORCID: 0000-0002-1667-1365 AD - Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Gottingen, 37075, Gottingen, Germany. FAU - Effertz, Thomas AU - Effertz T AD - Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Gottingen, 37075, Gottingen, Germany. FAU - Huser, Marc AU - Huser M AD - Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Gottingen, 37075, Gottingen, Germany. FAU - Beutner, Dirk AU - Beutner D AD - Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Gottingen, 37075, Gottingen, Germany. LA - eng GR - MED-EL/ PT - Journal Article DEP - 20240124 PL - United States TA - Laryngoscope JT - The Laryngoscope JID - 8607378 SB - IM OTO - NOTNLM OT - ball joint OT - middle ear prosthesis OT - partial ossicular replacement prosthesis EDAT- 2024/01/24 12:44 MHDA- 2024/01/24 12:44 CRDT- 2024/01/24 09:10 PHST- 2023/11/30 00:00 [revised] PHST- 2023/09/20 00:00 [received] PHST- 2024/01/05 00:00 [accepted] PHST- 2024/01/24 12:44 [medline] PHST- 2024/01/24 12:44 [pubmed] PHST- 2024/01/24 09:10 [entrez] AID - 10.1002/lary.31301 [doi] PST - aheadofprint SO - Laryngoscope. 2024 Jan 24. doi: 10.1002/lary.31301.