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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

Författare och institution:
C. A. den Besten (-); Joacim Stalfors (Institutionen för kliniska vetenskaper, sektionen för anestesi, biomaterial och ortopedi, Avdelningen för öron-, näs- och halssjukdomar); S. Wigren (-); J. I. Blechert (-); M. Flynn (-); Måns Eeg-Olofsson (Institutionen för kliniska vetenskaper, sektionen för anestesi, biomaterial och ortopedi, Avdelningen för öron-, näs- och halssjukdomar); R. Aggarwal (-); K. Green (-); R. C. Nelissen (-); E. A. M. Mylanus (-); M. K. S. Hol (-)
Publicerad i:
Otology & Neurotology, 37 ( 8 ) s. 1077-1083
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
Objective: 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. Study Design: Single follow-up visit of a previously completed multicenter, randomized, controlled trial. Patients: 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. Results: 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 < 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%. Conclusion: The 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.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Auditory osseointegrated implant, Baha, Bone-anchored hearing aid, Bone conduction, Hearing loss, Implant loss, Implant stability, ISQ, Soft tissue reactions, resonance frequency-analysis, baha implant, devices, multicenter, reliability, aids, Neurosciences & Neurology, Otorhinolaryngology
Postens nummer:
Posten skapad:
2016-09-30 16:26

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