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Randomized Controlled Trial Multicenter Study
Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial.
- Christine A den Besten, Joacim Stalfors, Stina Wigren, Johan Ivarsson Blechert, Mark Flynn, Måns Eeg-Olofsson, Rohini Aggarwal, Kevin Green, Rik C Nelissen, Emmanuel A M Mylanus, and Myrthe K S Hol.
- *Department of Otorhinolaryngology, Radboud University Medical Center, Nijmegen, The Netherlands †Department of Otorhinolaryngology, Sahlgrenska University Hospital, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden ‡Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden §Department of Otorhinolaryngology, Salford Royal Hospital, Salford, United Kingdom ||Department of Otorhinolaryngology, Manchester Royal Infirmary, Manchester, United Kingdom.
- Otol. Neurotol. 2016 Sep 1; 37 (8): 1077-83.
ObjectiveTo compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years.Study DesignSingle follow-up visit of a previously completed multicenter, randomized, controlled trial.PatientsFifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial.ResultsThe test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p < 0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p < 0.0001] and control group +2.25 [SD ±4.95, within group p = 0.12]). No difference was noticed in increase from baseline between groups (p = 0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p = 0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%.ConclusionThe test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.
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