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Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial.


ABSTRACT: To 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.Single follow-up visit of a previously completed multicenter, randomized, controlled trial.Fifty-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.The 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?

SUBMITTER: den Besten CA 

PROVIDER: S-EPMC4982756 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial.

den Besten Christine A CA   Stalfors Joacim J   Wigren Stina S   Blechert Johan Ivarsson JI   Flynn Mark M   Eeg-Olofsson Måns M   Aggarwal Rohini R   Green Kevin K   Nelissen Rik C RC   Mylanus Emmanuel A M EA   Hol Myrthe K S MK  

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20160901 8


<h4>Objective</h4>To 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.<h4>Study design</h4>Single follow-up visit of a previously completed multicenter, randomized, controlled trial.<h4>Patients</h4>Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underw  ...[more]

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