BackgroundOver the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma.MethodsA multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression.The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.DiscussionThis is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement.Trial registrationRegistered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14. Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618. This trial is sponsored by Oticon Medical AB.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1662-0) contains supplementary material, which is available to authorized users.
ObjectivePatients with bilateral vestibulopathy (BV) can still have residual “natural” function. This might interact with “artificial” vestibular implant input (VI-input). When fluctuating, it could lead to vertigo attacks. Main objective was to investigate how “artificial” VI-input is integrated with residual “natural” input by the central vestibular system. This, to explore (1) whether misalignment in the response of “artificial” VI-input is sufficiently counteracted by well-aligned residual “natural” input and (2) whether “artificial” VI-input is able to influence and counteract the response to residual “natural” input, to show feasibility of a “vestibular pacemaker.”Materials and methodsFive vestibular electrodes in four BV patients implanted with a VI were available. This involved electrodes with a predominantly horizontal response and electrodes with a predominantly vertical response. Responses to predominantly horizontal residual “natural” input and predominantly horizontal and vertical “artificial” VI-input were separately measured first. Then, inputs were combined in conditions where both would hypothetically collaborate or counteract. In each condition, subjects were subjected to 60 cycles of sinusoidal stimulation presented at 1 Hz. Gain, asymmetry, phase and angle of eye responses were calculated. Signal averaging was performed.ResultsCombining residual “natural” input and “artificial” VI-input resulted in an interaction in which characteristics of the resulting eye movement responses could significantly differ from those observed when responses were measured for each input separately (p < 0.0013). In the total eye response, inputs with a stronger vector magnitude seemed to have stronger weights than inputs with a lower vector magnitude, in a non-linear combination. Misalignment in the response of “artificial” VI-input was not sufficiently counteracted by well-aligned residual “natural” input. “Artificial” VI-input was able to significantly influence and counteract the response to residual “natural” input.ConclusionIn the acute phase of VI-activation, residual “natural” input and “artificial” VI-input interact to generate eye movement responses in a non-linear fashion. This implies that different stimulation paradigms and more complex signal processing strategies will be required unless the brain is able to optimally combine both sources of information after adaptation during chronic use. Next to this, these findings could pave the way for using the VI as “vestibular pacemaker.”
Intraperitoneal fat focal infarction (IFFI) represents a relatively rare acute abdominal condition essentially characterized by infarction and/or torsion of the greater omentum or an epiploic appendage. The spontaneous clinical evolution is favorable under medical treatment, and the imaging findings have been proved sufficiently typical to avoid unnecessary surgery in the great majority of cases. To our knowledge, we report the first case of IFFI of the lesser omentum. Despite the absence of definitive histologic proof, the diagnosis was possible through typical imaging findings extremely similar to those of more classic cases of IFFI but also through the spontaneous benign evolution.
A mid-scalar electrode array achieves a stable position in the cochlea in a small but representative group of patients. The methods applied in this work can be used for providing postoperative feedback for surgeons and for benchmarking electrode designs.
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