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A multi-center randomized controlled trial of soft tissue preservation using a hydroxyapatite-coated abutment in percutaneous bone conduction hearing implant surgery – 1-year clinical outcomes

Presenting Author: Marc van Hoof

Published online by Cambridge University Press:  03 June 2016

Marc van Hoof ,
Stina Wigren ,
Johan Ivarsson Blechert ,
Manuela Joore ,
Mattias Molin ,
Janny Hof ,
Joost van Tongeren ,
Jan Wouter Brunings ,
Lucien Anteunis  and
Maria Ines Rincon Piedrahita
...Show all authors
Marc van Hoof
Affiliation:
MUMC+
Stina Wigren
Affiliation:
Cochlear Bone Anchored Solutions AB
Johan Ivarsson Blechert
Affiliation:
Cochlear Bone Anchored Solutions AB
Manuela Joore
Affiliation:
MUMC+
Mattias Molin
Affiliation:
Statistiska Konsultgruppen, Göteborg, Sweden
Janny Hof
Affiliation:
MUMC+
Joost van Tongeren
Affiliation:
MUMC+
Jan Wouter Brunings
Affiliation:
MUMC+
Lucien Anteunis
Affiliation:
MUMC+
Maria Ines Rincon Piedrahita
Affiliation:
ENT department, Clinical University Hospital, Valencia, Spain
M.P. Martinez-Beneyto
Affiliation:
ENT department, Clinical University Hospital, Valencia, Spain
D.J.M. Mateijsen
Affiliation:
ENT department, Catharina Hospital, Eindhoven, The Netherlands
S.J.H. Bom
Affiliation:
ENT department, Deventer Hospital, Deventer, The Netherlands
O. Deguine
Affiliation:
ENT department, Purpan Hospital, Toulouse, France
A.J.M. van der Rijt
Affiliation:
ENT department, Amphia Hospital, Breda, The Netherlands
J. Marco Algarra
Affiliation:
ENT department, Clinical University Hospital, Valencia, Spain
R.J. Stokroos
Affiliation:
Maastricht University Medical Center, School for Mental Health and Neuroscience (MHENS), Department of ENT, Maastricht, The Netherlands
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Abstract

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Learning Objectives: To become aware of the clinical differences of soft tissue preservation surgery with a HA-coated abutment in comparison to the outcomes using the conventional technique.

Introduction: Soft tissue preservation using a hydroxyapatite-coated abutment may lead to a reduction in complications in percutaneous bone conduction hearing implant surgery. In this open multi-center, randomized(1:1), controlled clinical trial, eligible subjects were assigned to receive the conventional intervention, a titanium abutment (Cochlear™ Baha® BA300) with soft tissue reduction, or a new intervention, a hydroxyapatite-coated abutment(BA400) with soft tissue preservation. The primary outcome was a combined endpoint which included the secondary outcome measures pain, numbness, peri-abutment dermatitis and skin thickening/overgrowth.

Results: 106 subjects were randomized. The difference between the groups after one year of follow-up as measured by the primary efficacy variable was not statistically significant(p = 0.12) in the ITT population(n = 103), but was statistically significant(p = 0.03) in the Per-protocol population(n = 96). It showed an advantage for the test group, with over twice as many subjects(29%) with none of these important medical events during the first year compared to the control group(13%). Secondary outcome measures, such as surgical time (15 vs. 25 minutes, p < 0.01), numbness(90% vs. 69% of subjects experienced no numbness at one year, p < 0.01), neuropathic pain (mean score at 3 months, 1.06 ± 0.25 vs. 1.70 ± 1.53, p = 0.015) and the overall opinion of the esthetic outcome were favourable for the test group. Five abutments with tissue overgrowth had to be changed in the control group versus one in the test group. No significant differences existed in the occurrence of peri-abutment dermatitis(Holgers index). One implant extrusion was recorded in each group.

Conclusion: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a statistically significant and clinically meaningful reduction in numbness, neuropathic pain and surgical time, and improves cosmetic outcomes in comparison to soft tissue reduction surgery with a titanium abutment.