Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

Overview

Journal Otol Neurotol

Specialties Neurology
Otorhinolaryngology

Date 2018 Jul 12

PMID 29995008

Citations 18

Authors

Tim G A Calon

Martin L Johansson

Arthur J G de Bruijn

Herbert van den Berge

Mariet Wagenaar

Edwin Eichhorn

Miranda M L Janssen

Janny R Hof

Jan-Wouter Brunings

Manuela A Joore

Sofia Jonhede

Joost van Tongeren

Marcus Holmberg

Robert-Jan Stokroos

Affiliations

Soon will be listed here.

Abstract

Objective: To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).

Design: Sponsor-initiated multicenter, open, randomized, controlled clinical trial.

Setting: Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.

Participants: Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group.

Primary And Secondary Outcome Measurements: Primary objective: compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks' follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.

Results: Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.

Conclusion: No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

Citing Articles

Minimally invasive surgery as a new clinical standard for bone anchored hearing implants-real-world data from 10 years of follow-up and 228 surgeries.

Cruz L, Danieli F, Hakansson M, Johansson M, Dos Santos F, Reis A Front Surg. 2023; 10:1209927.

PMID: 37465065 PMC: 10351910. DOI: 10.3389/fsurg.2023.1209927.

Non-invasive sampling procedure revealing the molecular events at different abutments of bone-anchored hearing systems-A prospective clinical pilot study.

Johansson M, Omar O, Trobos M, Jonhede S, Peters H, Hultcrantz M Front Neurosci. 2022; 16:1058689.

PMID: 36440291 PMC: 9683095. DOI: 10.3389/fnins.2022.1058689.

The Minimally Invasive Star-Shaped Incision Technique and the Linear Incision Technique With Tissue Preservation for Percutaneous Bone Conduction Devices: A Retrospective Cohort Study.

Strijbos R, Salameh S, Bezdjian A, Daniel S, Thomeer H Front Surg. 2022; 9:863997.

PMID: 35756480 PMC: 9231669. DOI: 10.3389/fsurg.2022.863997.

Osseointegrated device placement with minimally invasive surgery: Experience and audiological outcome.

Aldhafeeri A, Yousef M, Alzhrani F Saudi Med J. 2022; 43(5):530-533.

PMID: 35537722 PMC: 9280602. DOI: 10.15537/smj.2022.43.5.20210913.

Evaluation of a New Drill System for Placement of Percutaneous Bone Conduction Devices.

Strijbos R, Straatman L, Stokroos R, Johansson M Front Surg. 2022; 9:858117.

PMID: 35388366 PMC: 8977416. DOI: 10.3389/fsurg.2022.858117.

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