Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices

Abstract

Objective: Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months.Methods: In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group. The primary outcome was an (adverse) soft tissue reaction. Secondary outcomes were pain, loss of sensibility, soft tissue height/overgrowth, skin sagging, implant loss, Implant Stability Quotient measurements, cosmetic scores, and quality of life questionnaires.Results: Sixty-three subjects were analyzed in the intention-to-treat population. No differences were found in the presence of (adverse) soft tissue reactions during complete follow-up. Also, there were no differences in pain, wound dehiscence, skin level, soft tissue overgrowth, and overall quality of life. Loss of sensibility (until 3-month post-surgery), cosmetic scores, and skin sagging outcomes were better in the MIPS group. The Implant Stability Quotient was higher after the LITT-P for different abutment lengths at various points of follow-up. Implant extrusion was nonsignificantly higher after the MIPS (15.2%) compared with LITT-P (3.3%).Conclusion: The long-term results show favorable outcomes for both techniques. The MIPS is a promising technique with some benefits over the LITT-P. Concerns regarding nonsignificantly higher implant loss may be overcome with future developments and research.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02438618.

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

“…It is possible that the reduced total drilling time and reduced heat generation may lead to less negative effects on the peri-implant bone and osseointegration ( 39 , 40 ). Moreover, since some studies have reported lower implant survival with MIPS compared with LITT-P ( 25 , 26 , 34 ), developments leading to improved implant survival and stability outcomes using minimally invasive approaches are warranted.…”

“…In addition to providing benefits to patients, improvements in clinical efficiency using MIPS have been reported in cost analysis studies ( 32 ). While several studies have reported comparable implant survival rates for MIPS compared to LITT-P ( 27 – 29 , 31 , 33 ), lower implant survival for MIPS has also been reported ( 25 , 26 , 34 ). Possible reasons can be the reduced visibility during the procedure, introducing a potential risk of angulated insertion or interposing soft tissue.…”

Multimodal Analysis of the Tissue Response to a Bone-Anchored Hearing Implant: Presentation of a Two-Year Case Report of a Patient With Recurrent Pain, Inflammation, and Infection, Including a Systematic Literature Review

“…The present study entails an elaborate case report of a patient with a clinically stable and osseointegrated implant reporting pain that persisted after abutment removal. This case patient was part of a larger controlled study evaluating the outcome after MIPS surgery compared with linear incision (Calon et al, 2018a;Strijbos et al, 2021). This gave the opportunity to apply a panel of modern analytical techniques on a specific, clinically used devices in addition to the available follow-up data.…”

“…A 39-year-old Caucasian female was treated for mixed hearing loss of the left ear by receiving a 4-mm Ponto Wide implant mounted with a 12-mm abutment (Oticon Medical, Askim, Sweden) in February 2015. The patient was enrolled in a multicenter, randomized, and controlled trial comparing two different techniques for installing the BAHS: the Minimally Invasive Ponto Surgery (MIPS) technique and the linear incision technique with soft tissue preservation (Calon et al, 2016;Calon et al, 2018a;Strijbos et al, 2021). The patient underwent implant surgery using the Minimally Invasive Ponto Surgery, MIPS (Oticon Medical) through a punch technique (Calon et al, 2016;Johansson et al, 2017).…”

“…The case is presented according to the CARE Guidelines (Riley et al, 2017), and provides a detailed analysis of a patient with recurrent adverse soft tissue reactions and pain, eventually leading to elective removal of the abutment and implant. The patient in this case report was enrolled in a larger clinical trial (Calon et al, 2018a;Strijbos et al, 2021) where data obtained in the trial, together with analyzes justified by the explant analysis, is presented. Techniques including analysis of microbial DNA using molecular fingerprinting, gene expression using quantitative real-time polymerase chain reaction (qPCR), X-ray microcomputed tomography (micro-CT), histology, histomorphometry, backscattered electron scanning electron microscopy (BSE-SEM), Raman spectroscopy, and fluorescence in situ hybridization (FISH) are employed.…”