Bone-anchored Device Research Articles

The Connected Life: Using Access Technology at Home, at School and in the Community

Hearing technologies such as hearing aids, cochlear implants and bone-anchored devices provide students with hearing loss with far greater access to auditory information (and most importantly, to spoken language) than even a decade ago. However, in a student’s daily life, many situations arise where effective communication and participation can be comprised by factors such as distance, noise, reverberation, difficulty hearing peer input, missing or obscured visual information (e.g., due to masks during the COVID-19 pandemic), speakers with accents or poor auditory/visual quality (e.g., on the phone or during online learning). Access technologies such as remote microphone systems, wireless connectivity platforms and captioning can be used to supplement and/or clarify auditory and visual information, so that students can fully participate in all aspects of their lives. This article discusses how access technologies can provide support for students in preschool, elementary, secondary and postsecondary education. The importance of universal design for access to public spaces, such as schools and community spaces, to ensure that individuals with hearing loss live in an equitable and inclusive world are also discussed.

Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study.

BackgroundPatients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited. MethodsThis was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing.ResultsAmong 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed. ConclusionAmong patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.

Osseointegration

Osseointegration is a technique that confers a number of advantages to amputees dissatisfied with traditional socket prostheses. An osseointegrated implant consists of a bone-anchored device attached to a patient’s residual limb, and a transdermal component, which connects the external prosthesis. By anchoring into bone, an osseointegrated prosthesis provides direct skeletal attachment, allowing for improved mobility and coordination, gait which more closely approximates a native limb, better proprioception, and obviation of the problems associated with the traditional socket—residuum interface, including poor socket fit and soft tissue irritation. Both the bony and soft tissue work of osseointegration warrant careful consideration. We recommend collaboration between rehabilitation, orthopedic, and plastic surgery teams at each step of the process.

Antimicrobial and enzyme-responsive multi-peptide surfaces for bone-anchored devices

Functionalization of dental and orthopedic implants with multiple bioactivities is desirable to obtain surfaces with improved biological performance and reduced infection rates. While many approaches have been explored to date, nearly all functionalized surfaces are static, i.e., non-responsive to biological cues. However, tissue remodeling necessary for implant integration features an ever-changing milieu of cells that demands a responsive biomaterial surface for temporal synchronization of interactions between biomaterial and tissue. Here, we successfully synthesized a multi-functional, dynamic coating on titanium by co-immobilizing GL13K antimicrobial peptide and an MMP-9 – a matrix metalloproteinase secreted by bone-remodeling osteoclasts – responsive peptide. Our co-immobilized peptide surface showed potent anti-biofilm activity, enabled effective osteoblast and fibroblast proliferation, and demonstrated stability against a mechanical challenge. Finally, we showed peptide release was triggered for up to seven days when the multi-peptide coatings were cultured with MMP-9-secreting osteoclasts. Our MMP-9 cleavable peptide can be conjugated with osteogenic or immunomodulatory motifs for enhanced bone formation in future work. Overall, we envisage our multifunctional, dynamic surface to reduce infection rates of percutaneous bone-anchored devices via strong anti-microbial activity and enhanced tissue regeneration via temporal synchronization between biomaterial cues and tissue responses.

Operative techniques in Otolaryngology: Hearing restoration options

Hearing loss in elderly patients, commonly referred to as age-related hearing loss (ARHL), is an increasingly significant cause of morbidity. ARHL noted to be the second most common illness in the elderly population, and can often be detrimental to the quality of life of patients. Presently, restorative treatment for age-related hearing loss is limited, however, multifactorial rehabilitation and management strategies exist. A pivotal aspect of management in ARHL is the use of amplifying hearing aids and implantable devices. At this time, options for amplification include external and internal hearing aids, middle ear implants, bone-anchored devices, and cochlear implants. Despite the presence of numerous management options, many patients with hearing loss are not using amplifying devices. This chapter discusses the different management options for ARHL including important considerations and operative techniques, with cochlear implants being discussed in a separate chapter.

Home Use of Remote Microphone Systems by Children with Hearing Loss

Home Use of Remote Microphone Systems by Children with Hearing Loss

Meta-analysis of the efficacy of bone anchorage and maxillary facemask protraction devices in treating skeletal class Ⅲ malocclusion in adolescents

To assess the efficacy of bone anchorage and maxillary facemask protraction devices in treating skeletal class Ⅲ malocclusion in adolescents. Articles relating to the use of bone anchorage and maxillary facemask protraction devices for treating skeletal class Ⅲ malocclusion in adolescents were searched from the databases of Cochrane Library, PubMed, EmBase, CNKI, and Wanfang database. Several inclusion and exclusion criteria were developed for the article screening. The clinical data were extracted, and the quality of the selected articles was evaluated. A Meta-analysis of SNA, SNB, ANB, ANS-Me, Wits, and U1-PP change was performed by using RevMan 5.3. Seven studies (264 patients) were included in the Meta-analysis. Among these studies, three were randomized controlled trials, and four were non-randomized controlled trials. Compared with the maxillary facemask protraction device group, the bone ancho-rage device group had higher SNA changes and lower ANS-Me, Wits, and U1-PP changes (P<0.05). No significant differences were observed in the SNB and ANB changes between these two groups. Compared with the maxillary facemask protraction device, the bone anchorage device can increase the extent of protraction of the maxilla and has better controls for the labial inclination of the maxillary anterior teeth in treating skeletal class Ⅲ malocclusion among adolescents. However, additional high-quality randomized controlled trials must be performed to verify the results.

International Society for the Advancement of Spine Surgery Policy 2019-Surgical Treatment of Lumbar Disc Herniation with Radiculopathy.

Lumbar disc herniation (LDH) is a frequent cause of low back pain and radiculopathy, disability, and diminution in quality of life. While nonsurgical care remains the mainstay of initial treatment, symptoms that persist for prolonged periods of time are well treated with discectomy surgery. A large body of evidence shows that, in patients with unremitting symptoms despite a reasonable period of nonsurgical treatment, discectomy surgery is safe and efficacious. In patients with symptoms lasting greater than 6 weeks, various forms of discectomy (open, microtubular, and endoscopic) are superior to continued nonsurgical treatment. The small but significant proportion of patients with recurrent disc herniation experience less improvement overall than patients who do not experience reherniation after primary discectomy. Lumbar discectomy patients with large annular defects (≥6 mm wide) are at a higher risk for recurrent herniation and revision surgery. Annular closure via a bone-anchored device has been shown to decrease the rate of recurrent disc herniation and associated reoperation in these high-risk patients. After a detailed review of the literature, current clinical evidence supports discectomy (open, microtubular, or endoscopic discectomy) as a medically necessary procedure for the treatment of LDH with radiculopathy in indicated patients. Furthermore, there is new scientific evidence that supports the use of bone-anchored annular closure in patients with large annular defects, who are at greater risk for recurrent disc herniation.

Porous titanium fiber mesh with tailored elasticity and its effect on stromal cells.

Porous titanium fiber mesh (TFM) is considered a suitable scaffold material for bone reconstruction. Also, TFM can be used to cover the surface of bone‐anchored devices, that is, orthopedic or dental implants. The titanium fiber size has an effect of the stiffness as well as porosity of the titanium mesh, which can influence the behavior of bone forming cells. Therefore, the aim of this study was to vary TFM composition, in order to achieve different stiffness, and to assess the effects of such variation on the behavior of bone marrow‐derived stromal cells (BMSCs). With that purpose, nine types of TFM (porosities 60–87%; fiber size 22–50 μm), were examined for their mechanical properties as well as their effect on the proliferation and differentiation of rat bone marrow‐derived stromal cells (rBMSCs) up to 21 days. Dynamic mechanical analysis revealed that the stiffness of TFM were lower than of solid titanium and decreased with larger fiber sizes. The stiffness could effectively be tailored by altering fiber properties, which altered the pore simultaneously. For the 22 and 35 μm size fiber meshes with the highest porosity, the stiffness closely matched the value found in literature for cortical bone. Finally, all tested TFM types supported the growth and differentiation of rBMSCs. We concluded that TFM material has been proven cytocompatible. Further preclinical studies are needed to assess which TFM type is most suitable as clinical use for bone ingrowth and bone regeneration.

Hard-wired Epimysial Recordings from Normal and Reinnervated Muscle Using a Bone-anchored Device.

A bone-anchored device was implanted trans-tibially in n = 8 sheep with a bipolar recording electrode secured epimysially to the peroneus tertius muscle. TMR was carried out in a single animal: the peroneus tertius was deinnervated and the distal portion of the transected nerve to the peroneus muscle was coapted to a transected nerve branch previously supplying the tibialis anterior muscle. For 12 weeks (TMR) or 19 weeks (standard procedure), epimysial muscle signals were recorded while animals walked at 2 km·h-1. After 19 weeks implantation following standard procedure, epimysial recording signal-to-noise ratio (SNR) was 18.7 dB (± 6.4 dB, 95% CI) with typical recordings falling in the range 10-25 dB. Recoveries in gait and muscle signals were coincident 6 weeks post-TMR; initial muscle activity was identifiable 3 weeks post-TMR though with low signal amplitude and signal-to-noise ratio compared with normal muscle recordings. Following recovery, muscle signals were recorded reliably over 19 weeks following implantation. In this study, targeted reinnervation was successful in parallel with bone-anchor implantation, with recovery identified 6 weeks after surgery.

Role of transpalatal vault fixation with 2.0 plate for transverse palatal expansion in segmental le fort osteotomy

Background: Segmental Le Fort I osteotomy is a predictable, well-established surgical technique that is commonly used to correct maxillary transverse discrepancies up to 6–7 mm in adults. However, transverse expansion of the maxilla with a segmental Le Fort I osteotomy is often associated with postsurgical instability and relapse. Different methods have been recommended to reduce the potential for transverse instability involving bone grafts or allografts at the palatal osteotomy site, use of palatal bars and expanders, interocclusal splints and transpalatal bone-anchored devices. However, transverse maxillary expansion with a segmental Le Fort I osteotomy is still considered the least stable surgical orthognathic procedure and overexpansion with stable fication method frequently recommended.

Semicircular Canal Pressure Changes During High-intensity Acoustic Stimulation.

Acoustic stimulation generates measurable sound pressure levels in the semicircular canals. High-intensity acoustic stimuli can cause hearing loss and balance disruptions. To examine the propagation of acoustic stimuli to the vestibular end-organs, we simultaneously measured fluid pressure in the cochlea and semicircular canals during both air- and bone-conducted sound presentation. Five full-cephalic human cadaveric heads were prepared bilaterally with a mastoidectomy and extended facial recess. Vestibular pressures were measured within the superior, lateral, and posterior semicircular canals, and referenced to intracochlear pressure within the scala vestibuli with fiber-optic pressure probes. Pressures were measured concurrently with laser Doppler vibrometry measurements of stapes velocity during stimulation with both air- and bone-conduction. Stimuli were pure tones between 100 Hz and 14 kHz presented with custom closed-field loudspeakers for air-conducted sounds and via commercially available bone-anchored device for bone-conducted sounds. Pressures recorded in the superior, lateral, and posterior semicircular canals in response to sound stimulation were equal to or greater in magnitude than those recorded in the scala vestibuli (up to 20 dB higher). The pressure magnitudes varied across canals in a frequency-dependent manner. High sound pressure levels were recorded in the semicircular canals with sound stimulation, suggesting that similar acoustical energy is transmitted to the semicircular canals and the cochlea. Since these intralabyrinthine pressures exceed intracochlear pressure levels, our results suggest that the vestibular end-organs may also be at risk for injury during exposure to high-intensity acoustic stimuli known to cause trauma in the auditory system.

Effectiveness of interceptive treatment of class III malocclusions with skeletal anchorage: A systematic review and meta-analysis.

Recently, new strategies for treating class III malocclusions have appeared. Skeletal anchorage appears to reduce the dentoalveolar effects while maximising the orthopaedic effect in growing patients. The purpose of this systematic review and meta-analysis is to examine the effectiveness of bone anchorage devices for interceptive treatment of skeletal class III malocclusions. Searches were made in the Pubmed, Embase, Scopus and Cochrane databases, as well as in a grey literature database, and were complemented by hand-searching. The criteria for eligibility were: patients who had undergone orthodontic treatment with skeletal anchorage (miniplates and miniscrews). Patients with syndromes or craniofacial deformities or who had undergone maxillofacial surgery were excluded. The following variables were recorded for each article: author, year of publication, type of study, sample size, dropouts, demographic variables, treatment carried out, radiographic study (2D or 3D), follow-up time, and quality of the articles on the Newcastle-Ottawa Scale. The means and confidence intervals of the following variables were employed: Wits, overjet, ANB, SNA and SNB. Initially, 239 articles were identified. After removing the duplicates and applying the selection criteria, 9 were included in the qualitative synthesis and 7 in the quantitative synthesis (meta-analysis). It may be concluded that skeletal anchorage is an effective treatment for improving skeletal Class III malocclusion, but when compared with other traditional treatments such as disjunction and face mask, there is no clear evidence that skeletal anchorage improves the results.

Auditory Gain, Quality of Life, and Audiological Benefits in Bone-Anchored Hearing Device Users in Fundaci&amp;#243;n Santaf&amp;#233; De Bogot&amp;#225;, Colombia

The objective of this study is to determine the auditory gain, quality of life, audiological benefits, in bone-anchored hearing device users (BAHA). It is a retrospective and concurrent evaluation of thirty patients fitted unilaterally and seven fitted bilaterally for at least six months. Patients were assessed with audiometric testing and application of Glasgow Benefit Inventory (GBI) and Abbreviated Profile of Hearing Aid Benefit (APHAB). Regarding sound-field pure audiometry results, we found a statistically significant gain in all frequencies using the bone-anchored device. APHAB scores showed statistically significant subjective audiological gains in all subscales except for the aversiveness subscale. GBI mean scores for all items in both groups were all above 3, suggesting quality of life improvement in conductive and mixed hearing loss patients. BP100 users showed a greater clinical gain in the APHAB global score and subscales compared with Divino users. In conclusion the BAHA provides significant auditory gain, subjective audiological benefits and improves quality of life in all BAHA users. This study shows a significant clinical and statistical benefit of BAHA measured by audiometric testing and by the APHAB and GBI questionnaires.

Bacterial biofilm on successful and failed orthodontic mini-implants--a scanning electron microscopy study.

Mini-implants have been extensively used in Orthodontics as temporary bone anchorage devices. However, early failure of mini-implants due to mobility might occur and the colonization of their surfaces by pathogenic bacteria has been referred to as one of the contributing factors. In this study, scanning electron microscopy (SEM) was used to assess the presence of microorganisms adhered to the surface of mini-implants that failed due to loss of stability. Twelve self-drilling titanium mini-implants (1.6 mm diameter × 9.0 mm long) were collected from 12 patients undergoing orthodontic treatment-7 successful and 5 failed mini-implants. The mean time of permanence in the mouth was 15.8 and 2.4 months for successful and failed mini-implants, respectively. The devices were placed in the maxilla and/or mandible and removed by the same surgeon and were processed for SEM analysis of the presence of microorganisms on their surfaces (head, transmucosal profile, and body). Extensive bacterial colonization on mini-implant head and transmucosal profile was observed in all successful and failed mini-implants. None of the failed mini-implants exhibited bacteria on its body and only one mini-implant belonging to the successful (stable) group exhibited bacteria on its body. The results did not suggest a relationship between failure and presence of bacterial colonies on mini-implant surfaces.

Contralateral Routing of Signal Hearing Aid versus Transcutaneous Bone Conduction in Single-Sided Deafness

The aim of this study was to compare a contralateral routing of signal (CROS) hearing aid to a transcutaneous bone-anchored device in the same conditions. This prospective crossover study included 18 adult patients with a single-sided deafness (SSD). After a trial period of 60 days with CROS and 7 days with a transcutaneous bone-anchored device (Alpha 1®, Sophono, Boulder, Colo., USA) on a headband, 13 (72%) patients opted for Alpha 1, 2 patients for CROS, and 3 rejected both rehabilitation methods. Clinical tolerance, satisfaction, hearing performances (pure-tone audiometry, speech test in quiet and in noise, stereo audiometry, sound localization, and Hearing in Noise Test), and quality of life (Glasgow Benefit Inventory, Abbreviated Profile of Hearing Aid Benefit and Glasgow Hearing Aid Benefit questionnaires) were measured at 3 and 12 months after the implantation. Both devices improved equally the hearing in noise and the quality of life. Transcutaneous devices represent an effective option in SSD.

Primary Failure of Eruption (PFE) and ankylosis of permanent molars: the surgeon’s experience

Eruption abnormalities involving permanent molars are clinically rare and can be particularly challenging to treat. When there is an obstacle in the eruption pathway, these teeth can be successfully set in the arch most of the time, once the obstacle is cleared. On the other hand, teeth afflicted with ankylosis or Primary Failure of Eruption (PFE) cannot be orthodontically displaced.PFE has a genetic origin and leads to open bite that can be severe, in relation to a reduced alveolar height. PFE is often also associated with class III malocclusion and dental agenesis, which makes the treatment plan even more complicated.This article first describes the characteristics of PFE and ankylosis and then presents our own experience, through several clinical cases. One case illustrates and discusses the limits of orthodontics in managing molars showing PFE, despite alveolar corticotomies and bone anchorage devices. Two other clinical cases describe global rehabilitation by osteotomy, bone graft and extensive prosthetic replacement.

Functional treatment of skeletal Class II malocclusion using bone-anchored devices and intermaxillary elastics

Introduction: Dentofacial functional appliances used for the treatment of skeletal Class II malocclusion are divided into two groups: Removable appliances and fixed (bonded) appliances, each with certain advantages and disadvantages. Considering the problems related to functional appliances such as high volume in the oral cavity, patient noncompliance, esthetics, tissue irritation or ulceration, speech or breathing difficulties, etc., there is considerable demand to develop a new appliance that can overcome these issues. Thus, the aim of the current study is to present a hypothesis regarding a new functional treatment technique. The hypothesis: We hypothesize that by fixing mini-plates or -implants in the posterior region of the mandible and the anterior part of the infrazygomatic crest region of the maxilla using intermaxillary elastics, we can expect a forward growth of the mandible in a growing child. Using this technique, the force vector will be in the oblique (forward-upward) direction. By installing mini-plates with a long connecting bar in the infrazygomatic crest region (with the orthodontic attachment head approximating the level of the occlusal plane), and mini-plates or -implants in the most posterior and superior regions of the mandible, such as the retromolar region, the force vector can be placed in the most horizontal direction possible. Evaluation of the hypothesis: In the literature, significant growth modification results were reported in skeletal Class III patients using intermaxillary elastics and bone-anchored devices fixed in both jaws, when compared with those in the nontreatment group. Therefore, in practice, intermaxillary elastics can produce enough traction to stimulate the bone to change and grow. Thus, we presume that inverting the direction of the force vector (i.e., posterior-anterior force) may have similar growth effects on the mandibles of growing children.

Translabyrinthine Tumor Removal with Concurrent Bone‐Anchored Hearing Aid Placement

Objectives: (1) Describe the safety profile of performing translabyrinthine tumor removal and bone-anchored hearing aid placement during the same surgical procedure. (2) Describe the overall patient satisfaction of those individuals who underwent the above procedure. Methods: Retrospective review from a tertiary neurotologic referral center of 154 patients who underwent concurrent translabyrinthine tumor resection and bone-anchored hearing device placement between 2004 and 2012. Patient records were reviewed to identify postoperative complication rates and bone-anchored hearing device usage. A Fisher’s exact test was used to compare the qualitative variables and Student t test was used for the quantitative comparison. Results: One hundred twenty-one (78.6%) of 154 patients undergoing concurrent translabyrinthine tumor removal and bone-anchored hearing device placement had no device-related complications. The most common device-related complications were skin overgrowth (8.4%), acute infection (5.2%), and chronic infection (3.2%). The overall and specific complication rates did not statistically differ from published bone-anchored device complication rates (all P &lt; .05). One patient (0.7%) developed a cerebrospinal fluid leak at the placement site of the bone-anchored device. Of the 145 patients with at least 1-year follow-up, 137 (95.5%) were still regularly using their bone-anchored hearing devices. Conclusions: Patients undergoing concurrent translabyrinthine tumor removal and bone-anchored hearing device placement exhibit similar device-related complication profiles as patients undergoing standard device placement. Based on these outcomes and the high long-term usage rates, translabyrinthine intracranial surgery and bone-anchored hearing device insertion can be considered a useful and safe procedure.

A Brief Review of Cochlear™ Baha® Osseointegrated Solutions for the Treatment of Hearing Loss

This article serves as an overview of the topic of implantable bone-anchored devices for the treatment of conductive, mixed-conductive, and single-sided sensorineural deafness. The author describes...