TY - JOUR
T1 - Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing
T2 - Long-Term Follow-Up of a Randomized Controlled Trial
AU - den Besten, Christine A
AU - Stalfors, Joacim
AU - Wigren, Stina
AU - Blechert, Johan Ivarsson
AU - Flynn, Mark
AU - Eeg-Olofsson, Måns
AU - Aggarwal, Rohini
AU - Green, Kevin
AU - Nelissen, Rik C
AU - Mylanus, Emmanuel A M
AU - Hol, Myrthe K S
PY - 2016/9
Y1 - 2016/9
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Bone Conduction
KW - Female
KW - Follow-Up Studies
KW - Hearing Aids
KW - Hearing Loss
KW - Humans
KW - Male
KW - Middle Aged
KW - Osseointegration
KW - Postoperative Complications/epidemiology
KW - Prostheses and Implants/adverse effects
KW - Treatment Outcome
U2 - 10.1097/MAO.0000000000001111
DO - 10.1097/MAO.0000000000001111
M3 - Article
C2 - 27482783
SN - 1531-7129
VL - 37
SP - 1077
EP - 1083
JO - Otology & Neurotology
JF - Otology & Neurotology
IS - 8
ER -