https://ogma.newcastle.edu.au/vital/access/ /manager/Index en-au 5 A multinational cost-consequence analysis of a bone conduction hearing implant system - a randomized trial of a conventional vs. a less invasive treatment with new abutment technology https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:38255 Thu 19 Aug 2021 12:14:52 AEST ]]> Clinical outcomes of soft tissue preservation surgery with hydroxyapatite-coated abutments compared to traditional percutaneous bone conduction hearing implant surgery-a pragmatic multi-center randomized controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:38820 p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.]]> Fri 11 Feb 2022 16:16:48 AEDT ]]>