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

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.

Microbiome on the Bone-Anchored Hearing System: A Prospective Study

“…This study is part of a larger trial comparing two surgical techniques for installing BAHS (Calon et al, 2016) and the short-term clinical results have recently been published (Calon et al, 2018). This study was performed in accordance with the Dutch legislation of Medical Research Involving Human Patients Act and with the ethical standards on human experimentation in the Netherlands.…”

“…All patients provided written informed consent. Complete clinical data, including additional patients not participating in the swab collection, have been published previously (Calon et al, 2018). This paper reports on the subset of patients where swab samples were collected.…”

“…It is an established therapy for patients suffering from several types of hearing loss including conductive hearing loss, mixed hearing loss, and single sided deafness (Snik et al, 2005; Faber et al, 2015). During the last years, treatment options have become less invasive, resulting in improved outcomes regarding esthetics, pain, numbness of the skin, implant survival, and soft tissue reactions (Hultcrantz, 2013; den Besten et al, 2016; Calon et al, 2018). Soft tissue reactions, such as inflammation of the peri-abutment skin, are still a common complication, but the majority of cases are relatively easily treated (Dun et al, 2012; Verheij et al, 2016).…”

Long term follow-up demonstrating stability and patient satisfaction of minimally invasive punch technique for percutaneous bone anchored hearing devices

“…While details of other experiences are limited, there are mixed results reported [ 6 ]. The highly anticipated long-term, multi-centre MIPS outcomes data recently published showed no difference in inflammation compared to linear incisions [ 7 – 9 ]. There was improvement in skin sensation, sagging, cosmetic result and reduction of surgical time but a non-significant increase in implant extrusion rate that warrants further investigation [ 7 – 9 ].…”

Bone Conduction Implants for Hearing Rehabilitation in Skull Base Tumor Patients

“…When compared with traditional techniques, this form of surgery has been shown to improve periincisional numbness, cosmetic results, and operative time. 10,11 In the case of a transcutaneous BCI, incisions are usually larger to account for the increased size of the implant (►Fig. 4).…”