Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing

Objective: To compare 3-year implant stability, survival, and tolerability of a 4.5-mm-wide (test) and a 3.75-mm-wide (control) percutaneous titanium implant for bone-conduction hearing, loaded with the sound processor after 3 weeks. Methods: Sixty implants were allocated in a 2:1 ratio (test-control) in 57 adult patients included in this prospective randomized controlled clinical trial. Follow-up visits were performed at 7, 14, 21, and 28 days; 6 and 12 weeks; 6 months; and at 1, 2, and 3 years after implantation. During these visits, the implant stability quotient (ISQ) was measured by means of resonance frequency analysis (RFA). The peri-abutment soft tissue status was assessed according to the Holgers classification. Skin height around the abutment was evaluated. Results: The mean area-under-the-curve (AUC) of ISQ-low was statistically significantly higher for the test implant (65.7 versus 61.4, p = 0.0002). Both implants showed high survival rates (97.4% versus 95.0%, p = 0.6374). Adverse soft tissue reactions were observed sporadically, with no significant inter-group differences. Skin thickening was seen in the majority of the patients, but no correlation with adverse soft tissue reactions or implant type was observed. Conclusion: The 4.5-mm-wide implant provides significantly higher ISQ values during the first 3 years after surgery compared with the previous generation 3.75-mm-wide implant. Both implants showed high survival rates and good tolerability. These long-term results indicate that the wider implant, loaded with a sound processor at 3 weeks, is a safe and well-performing option for hearing rehabilitation in specific types of hearing loss. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://ift.tt/OBJ4xP Address correspondence and reprint requests to Ivo J. Kruyt, M.D., Department of ENT, Radboudumc, PO Box 9101, 6500 HB Nijmegen, The Netherlands; E-mail: Ivo.Kruyt@radboudumc.nl Funding: Oticon Medical AB (Askim, Sweden) acted as sponsor and provided financial support for this study. The authors report financial support to the authors’ institution (Radboudumc) for conducting clinical studies from Oticon Medical AB (Askim, Sweden) and from Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden), also outside the submitted work. The authors declare that they have no other conflict of interest. Copyright © 2018 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

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