Dataset Information

In-office Bone-Anchored Hearing Implants via Minimally Invasive Punch Technique in a Veteran Population.

ABSTRACT:

Objective

Describe the feasibility and safety of completing bone-anchored hearing implants via the minimally invasive punch technique in the in-office setting.

Study design

This single-institution case series included 20 patients who underwent in-office bone-anchored hearing implant placement under local anesthesia from 2018 to 2021.

Setting

Veterans Affairs Northern California Healthcare System.

Methods

Following completion of the case series, patients were retrospectively surveyed regarding their satisfaction with this approach via a modified SSQ-8 (Surgical Satisfaction Questionnaire) to fit our purposes.

Results

A total of 23 implants were completed in the in-office setting on 20 patients. Intra- and postoperative complication rates, including skin changes, irritation, infection, and poor wound healing, were similar to or better than currently published complication rates in the literature. In addition, patients reported overwhelmingly positive responses on the SSQ-8, almost universally stating that they were "very satisfied" with their clinic experience.

Conclusion

This case series suggests that it is feasible and safe to complete this procedure in the clinic under local anesthesia, but further prospective studies are needed to evaluate this in a more generalized population.

SUBMITTER: King J

PROVIDER: S-EPMC9720705 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

In-office Bone-Anchored Hearing Implants via Minimally Invasive Punch Technique in a Veteran Population.

King Jackson J Leon Isabella I Squires Lane L

Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery 20220329 6

<h4>Objective</h4>Describe the feasibility and safety of completing bone-anchored hearing implants via the minimally invasive punch technique in the in-office setting.<h4>Study design</h4>This single-institution case series included 20 patients who underwent in-office bone-anchored hearing implant placement under local anesthesia from 2018 to 2021.<h4>Setting</h4>Veterans Affairs Northern California Healthcare System.<h4>Methods</h4>Following completion of the case series, patients were retrospe ...[more]

PMID: 35349358

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Project description:ObjectiveTo 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).DesignSponsor-initiated multicenter, open, randomized, controlled clinical trial.SettingMaastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.ParticipantsSixty-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 measurementsPrimary 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.ResultsSixty-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.ConclusionNo 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.

Project description: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.

Project description:Osseointegrated implants inserted in the temporal bone are a vital component of bone-anchored hearing systems (BAHS). Despite low implant failure levels, early loading protocols and simplified procedures necessitate the application of implants which promote bone formation, bone bonding and biomechanical stability. Here, screw-shaped, commercially pure titanium implants were selectively laser ablated within the thread valley using an Nd:YAG laser to produce a microtopography with a superimposed nanotexture and a thickened surface oxide layer. State-of-the-art machined implants served as controls. After eight weeks' implantation in rabbit tibiae, resonance frequency analysis (RFA) values increased from insertion to retrieval for both implant types, while removal torque (RTQ) measurements showed 153% higher biomechanical anchorage of the laser-modified implants. Comparably high bone area (BA) and bone-implant contact (BIC) were recorded for both implant types but with distinctly different failure patterns following biomechanical testing. Fracture lines appeared within the bone ~30-50 μm from the laser-modified surface, while separation occurred at the bone-implant interface for the machined surface. Strong correlations were found between RTQ and BIC and between RFA at retrieval and BA. In the endosteal threads, where all the bone had formed de novo, the extracellular matrix composition, the mineralised bone area and osteocyte densities were comparable for the two types of implant. Using resin cast etching, osteocyte canaliculi were observed directly approaching the laser-modified implant surface. Transmission electron microscopy showed canaliculi in close proximity to the laser-modified surface, in addition to a highly ordered arrangement of collagen fibrils aligned parallel to the implant surface contour. It is concluded that the physico-chemical surface properties of laser-modified surfaces (thicker oxide, micro- and nanoscale texture) promote bone bonding which may be of benefit in situations where large demands are imposed on biomechanically stable interfaces, such as in early loading and in compromised conditions.

Dataset Information

In-office Bone-Anchored Hearing Implants via Minimally Invasive Punch Technique in a Veteran Population.

Objective

Study design

Setting

Methods

Results

Conclusion

Publications

In-office Bone-Anchored Hearing Implants via Minimally Invasive Punch Technique in a Veteran Population.

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