Safety and Efficacy of Implantation of the Bonebridge Active Transcutaneous Bone-Conduction Device Using Implant Lifts

2021 ◽  
Author(s):  
Faris F. Brkic ◽  
Dominik Riss ◽  
Christoph Arnoldner ◽  
Rudolfs Liepins ◽  
Wolfgang Gstöttner ◽  
...  
Keyword(s):  
Word Recognition ◽  
Bone Conduction ◽  
Safety And Efficacy ◽  
Hearing Gain ◽  
Significant Difference ◽  
Bone Conduction Device ◽  
Medical Referral ◽  
Mean Time ◽  
Observation Period

Abstract Background Implant lifts were recently introduced to facilitate implantation of the Bonebridge and to reduce the risk of uncovering the sigmoid sinus and/or dura. Purpose The current study analyzed medical, technical, and audiological outcomes of implantation with the Bonebridge implant using lifts. Research Design This was a retrospective study on all consecutive patients implanted with a bone-conduction hearing implant at a tertiary medical referral center between March 2012 and October 2018. Outcome measures were complications, explantations, and revisions and the mean time of implant use. Audiological results were assessed as well. Outcomes were evaluated for devices implanted with BCI Lifts and compared with those implanted without lifts. Results In the study period, 13 out of a total of 54 implantations were conducted using one or two 1- to 4-mm BCI Lifts. During the follow-up period, two complications occurred and both in patients implanted without lifts (2/41; 4.9%). All patients in the lifts group were using the implant at the end of observation period. No statistically significant difference was observed in functional hearing gain or word-recognition improvement at 65 dB between two groups. Conclusions The use of BCI Lifts in Bonebridge implantations was not associated with adverse events during the observation period. The clinical follow-up revealed no complications in implantations requiring lifts. Furthermore, the functional hearing gain and the word-recognition improvement did not differ from those of devices implanted without lifts. Data indicate safety and efficacy for Bonebridge implantations using lifts.

Bone Cement Fixation of Stapedotomy Prostheses: Long-term Outcomes in Primary and Revision Stapes Surgery

2020 ◽  
pp. 000348942097133
Author(s):  
Pedrom C. Sioshansi ◽  
Amy Schettino ◽  
Seilesh C. Babu ◽  
Dennis I. Bojrab ◽  
Eric W. Sargent ◽  
...  
Keyword(s):  
Word Recognition ◽  
Bone Cement ◽  
Bone Conduction ◽  
Stapes Surgery ◽  
Long Term Outcomes ◽  
Significant Difference ◽  
Long Term Follow Up ◽  
Revision Stapes Surgery

Objectives: To describe audiologic outcomes following hydroxyapatite bone cement fixation of stapedotomy prostheses. Methods: A retrospective case review at a tertiary neurotology referral center was performed of patients undergoing primary or revision stapedotomy between 2010 and 2017. Patients with hydroxyapatite bone cement fixation of stapes prostheses were assessed. Pre- and postoperative hearing was compared, consisting of air conduction (AC) and bone conduction (BC) pure-tone averages (PTA), air-bone gap (ABG), and word recognition scores (WRS). Short and long-term outcomes were assessed. Results: Forty-six patients with otosclerosis underwent stapedotomy with bone cement fixation: 21 primary cases and 25 revision cases, with an average follow-up time of 17 months. Mean AC PTA was 56 dB preoperatively, and 34 dB postoperatively ( P < .0001), while the ABG improved on average from 27 dB to 9 dB ( P < .0001). There was no significant difference in postoperative ABG between primary and revision stapes surgery (6 dB vs 10 dB, P = .07). These results persisted through long-term follow-up in a subgroup of patients with significantly longer follow-up time (mean 44 months). There was no significant change in BC PTA or word recognition scores. Three patients underwent subsequent revisions, one patient developed sensorineural hearing loss. Conclusion: Stapedotomy with bone cement fixation of the prosthesis provides excellent hearing outcomes in both primary and revision treatment of otosclerosis. Results are consistent and stable through long-term follow-up. The use of bone cement should be incorporated into the surgical armamentarium of the otologist for the prevention and treatment of loose-wire syndrome and incus necrosis.

Tear Rates of the Ipsilateral ACL Graft and the Contralateral Native ACL Are Similar following ACL Reconstruction

2020 ◽  
Author(s):  
Nadia Nastassia Ifran ◽  
Ying Ren Mok ◽  
Lingaraj Krishna
Keyword(s):  
Acl Reconstruction ◽  
Medical Records ◽  
Cruciate Ligament ◽  
Acl Graft ◽  
Increased Risk ◽  
Significant Difference ◽  
The Mean ◽  
Anterior Cruciate ◽  
Mean Time

AbstractThe aim of the study is to compare the tear rates of ipsilateral anterior cruciate ligament (ACL) grafts and the contralateral native ACL as well as to investigate the correlation of gender, age at time of surgery, and body mass index (BMI) with the occurrence of these injuries. The medical records of 751 patients who underwent ACL reconstruction surgery with follow-up periods of 2 to 7 years were retrospectively analyzed. Survival analyses of ipsilateral ACL grafts and contralateral native ACL were performed. Univariate and multivariate logistic regression analyses were performed to identify risk factors that were associated with these injuries. The tear rates of the ipsilateral ACL graft and contralateral ACL were 5.86 and 6.66%, respectively with no significant difference between groups (p = 0.998). The mean time of tears of the ipsilateral ACL and contralateral ACL was also similar (p = 0.977) at 2.64 and 2.78 years, respectively after surgery. Both the odds of sustaining an ipsilateral ACL graft and contralateral ACL tear were also significantly decreased by 0.10 (p = 0.003) and 0.14 (p = 0.000), respectively, for every 1-year increase in age at which the reconstruction was performed. However, graft type, gender, and BMI were not associated with an increased risk of these injuries. There was no difference between tear rates of ipsilateral ACL graft and contralateral ACL following ACL reconstruction. Patients who undergo ACL reconstruction at a young age are at an increased risk of both ipsilateral graft and contralateral ACL rupture after an ACL reconstruction. Patients who are young and more likely to return to competitive sports should be counselled of the risks and advised to not neglect the rehabilitation of the contralateral knee during the immediate and back to sports period of recovery. This is a Level III, retrospective cohort study.

Abstract 1122‐000132: Fuoxetine for Recovery After Stroke: A Pooled Analysis of 7165 Patients

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Mohamed Fahmy Doheim ◽  
Ahmed Elsnhory ◽  
Mohammed Elgammal ◽  
Abdulrahman Ibrahim Hagrass ◽  
Ahmed Hanbal ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Bone Fractures ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Stroke Patients ◽  
Permanent Disability ◽  
Safety And Efficacy ◽  
Nihss Score ◽  
Significant Difference

Introduction : Stroke is one of the predominant causes of permanent disability, mortality, significant cognitive, physical, and psychosocial morbidity in the world. We conducted this systematic review and meta‐analysis to assess the safety and efficacy of fluoxetine for recovery stroke patients through different time points of follow up. Methods : We searched in PubMed, Cochrane Library, Scopus, and Web of Science databases/ search engines until June 2021. Mean difference (MD) with 95% confidence interval (CI) was applied for continuous data, while risk ratio (RR) with 95% CI was used for dichotomous data. Results : Seventeen randomized clinical trials were identified which assessed the safety and efficacy of fluoxetine compared to placebo for stroke patients. Fluoxetine enhances the National Institutes of Health Stroke Scale (NIHSS) score [MD = ‐0.67, 95 % CI (‐1.19 to ‐0.15), P = 0.01] and the Fugl‐Meyer Motor Scale (FMMS) score [MD = 17.36, 95 % CI (12.12 to 22.61), P <0.00001] at three months follow up. However, the NIHSS score showed no significant difference between the two groups at two weeks [MD = ‐0.32, 95% CI (‐0.72 to 0.07), p = 0.11] or at six months [MD = ‐0.17,95% CI (‐0.47 to 0.14), p = 0.29]. Fluoxetine and placebo‐treated patients had the same overall impact on FMMS scores at one month [MD = 7.77, 95 % CI (‐10.57 to 26.11), P = 0.41]. The fluoxetine arm had a higher risk of broken bone (RR = 2.30, 95% CI [1.59, 3.32], p < 0.001) and hyponatremia (RR = 2.12, 95% CI [1.19, 3.76], p = 0.01) with lower risk of new depression (RR = 0.72, 95% CI [0.61, 0.84], p< 0.001) in comparison to the placebo arm. Conclusions : The efficacy of fluoxetine is likely to take time to emerge, and is expected to be transient. The use of fluoxetine increased the incidence of hyponatremia and bone fractures while decreasing the risk of new‐onset depression.

scholarly journals A comparative study of fracture shaft of femur in adults treated with broad dynamic compression plate versus intramedullary interlocking nail

2016 ◽  
Vol 12 (2) ◽  
pp. 66-69
Author(s):  
Sushil Thapa ◽  
Shrawan Kumar Thapa ◽  
Shankar Dhakal ◽  
Rudra Marasini ◽  
Bhadra Hamal ◽  
...  
Keyword(s):  
Dynamic Compression ◽  
Femoral Shaft ◽  
Plate Versus ◽  
Femoral Diaphysis ◽  
Medical Sciences ◽  
Significant Difference ◽  
Lost To Follow Up ◽  
Mean Time ◽  
Time From Injury

Background and Objectives: Diaphyseal femur fracture is one of the commonest fractures to present in an emergency room. The objective of the study was to compare femoral shaft fractures treated using nail with those using plate and screws. Patients and Methods: We studied a total of 62 patients of fracture shaft of femur admitted in the Bharatpur Hospital, Bharatpur, Chitwan and National Academy of Medical Sciences, BirHospital,Kathmandu. Two cases were lost to follow up. Thirty cases were treated with plating and 30 cases with nailing. The age group was from 16-30 years. Fifty-three were male and seven were females. Fifty-eight patients had closed fracture and two had Gustillo Anderson grade I openfracture. Result: Time from injury to surgery was 19 days on an average. Mean time for union was more in patients treated by plating, 19.46 weeks as compared to nailing 14.78 weeks. We found one case of infection with plating and breakage of plate in four patients. One patient with nailing did not show any signs of healing and two had failure in case of nailing. Our series revealed 23(38.3%) excellent, five (8.3%) good and two (3.3%) poor results in patients who had nailing while 15 (25.5%) excellent, nine (15%) good, one (1.7%) fair and five (8.3%) poor in patients who had plating out of 30 patients in each group. Conclusion:In our study we found that there was no significant difference in outcomes between plating and intramedullary nailing of femoral diaphysis fracture in terms of union, infection and implant failure.JCMS Nepal. 2016;12(2):66-9.

scholarly journals Medical, Technical and Audiological Outcomes of Hearing Rehabilitation with the Bonebridge Transcutaneous Bone-Conduction Implant: A Single-Center Experience

2019 ◽  
Vol 8 (10) ◽  
pp. 1614 ◽  
Author(s):  
Brkic ◽  
Riss ◽  
Scheuba ◽  
Arnoldner ◽  
Gstöttner ◽  
...  
Keyword(s):  
Hearing Aids ◽  
Bone Conduction ◽  
Technical Failure ◽  
Single Center ◽  
Hearing Rehabilitation ◽  
Device Failure ◽  
Hearing Gain ◽  
Bone Conduction Implant ◽  
The Mean

Bone-conduction implants are a standard therapeutic option for patients with conductive, unilateral, or mixed hearing loss who either do not tolerate conventional hearing aids or can benefit from surgery. The aim of this study was to evaluate long-term medical and technical outcomes, and audiological results with the Bonebridge transcutaneous bone-conduction implant. This retrospective study included all patients implanted with a bone-conduction hearing implant at a tertiary medical referral center between March 2012 and October 2018. Medical and technical outcomes included the mean length of implant usage, medical and technical complications (skin and wound infection, lack of benefit, technical failure), explantations and revisions, coupling approaches, implant failure rate, implant survival and the implant loss for added follow-up years. Auditory results were measured by functional hearing gain and the Freiburger monosyllabic test at 65 dB sound pressure level. Sixty-four patients were included in the study; five of these were implanted bilaterally (69 devices). Five unilaterally implanted patients were lost to follow-up. The mean follow-up was 27.1 months (range: 0.2 months–6.3 years). The mean implant usage was 25.9 months (range: 0.2 months–6.3 years). Fifty-seven implants (89.1%) were in use at the end of the follow-up period. Complications occurred in six ears (9.4%). Five implants (7.8%) were explanted without reimplantation. Device failure occurred in one implant (1.6%), which was possibly caused by recurrent head trauma. The rate of implant loss due to technical device failure (damage to device) was 1 per 72 follow-up years. The mean improvement on the Freiburger monosyllabic test (52.1%, p = 0.0001), and in functional hearing gain across frequencies (26.5 dB, p = 0.0001) was significant. This single-center follow-up reveals the medical and technical reliability of a transcutaneous bone-conduction implant for hearing rehabilitation because complication and revision rates were low. The majority of patients still used the device at the end of the observation period. Implantation resulted in favorable hearing outcomes in comparison to that of unaided conditions. Cautious patient selection mainly regarding co-morbidities, the history of chronic otologic diseases and proper surgical technique seems to be crucial in reducing complications.

scholarly journals Arrest of root caries with an adjuvant chlorhexidine–fluoride varnish over a 12-months observation period: a QLF-analyzed, placebo-controlled, randomized, clinical trial (RCT)

Odontology ◽  
2021 ◽  
Author(s):  
Kyung-Jin Park ◽  
Thomas Meißner ◽  
Elena Günther ◽  
Gerhard Schmalz ◽  
Tanja Kottmann ◽  
...  
Keyword(s):  
Root Surface ◽  
Bacterial Activity ◽  
Fluoride Varnish ◽  
Lesion Volume ◽  
Root Caries ◽  
Carious Lesions ◽  
Significant Difference ◽  
Topical Fluoride ◽  
Observation Period

AbstractThis study aimed at evaluating the effectiveness of an adjuvant chlorhexidine–fluoride varnish (Cervitec F) for prevention and arrest of root caries on elderly participants using quantitative light-induced fluorescence (QLF). 23 participants with two or three non-cavitated root carious lesions were included and assigned to three groups of different varnishes (CF: Cervitec F, P: placebo, DP: Duraphate). Agents were applied once to root surface at baseline and in follow-up after 3, 6 and 9 months. The lesions were assessed clinically and with QLF. QLF-images were analyzed regarding fluorescence loss (ΔF), lesion volume (ΔQ) and bacterial activity (ΔR) before (t0), after 14 days (t1), 6- (t2) and 12-months (t3). CF showed a significant difference between t0 and t3: ∆F (− 12.51 [15.41] vs. − 7.80 [16.72], p = 0.012), ∆Q (− 2339.97 (20,898.30) vs. − 751.82 (5725.35), p < 0.001), ∆R (23.80 [41.70] vs. 7.07 [37.50], p = 0.006). Independently of the varnish application, preventive care seems positively influence the root caries progress. Although within CF group the strongest effect was observed, no superiority of a specific varnish application was confirmed over a 12-months QLF observation period. Extra topical fluoride can help remineralise dentin lesions and QLF can be used as a measurement method to determine changes in the dentin lesions.

scholarly journals Enlargement rate of geographic atrophy before and after secondary CNV conversion with associated anti-VEGF treatment

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jakob Siedlecki ◽  
Caroline Koch ◽  
Benedikt Schworm ◽  
Raffael Liegl ◽  
Thomas Kreutzer ◽  
...  
Keyword(s):  
Growth Rate ◽  
Geographic Atrophy ◽  
Vascular Endothelial ◽  
Anti Vegf ◽  
Significant Difference ◽  
Before And After ◽  
Endothelial Growth Factor ◽  
Mean Time ◽  
Larger Sample

Abstract Background To study the enlargement rate of primary geographic atrophy (GA) before and after diagnosis of a secondary choroidal neovascularization (CNV) treated with anti-vascular endothelial growth factor (VEGF) therapy. Methods Five hundred twenty-two consecutive eyes with primary GA were screened for the development of a complicating secondary CNV. Geographic atrophy was measured on blue autofluorescence (BAF) by two readers and calculated into mean growth rate before and after CNV diagnosis. Results Ten eyes of six patients were included in the study (six study eyes with GA complicated by CNV, four GA only partner eyes). Follow-up was 1.42 ± 0.48 years before and 3.64 ± 2.73 years after CNV. There was no significant difference between mean growth rate before and after CNV (1.58 ± 0.99 vs. 1.39 ± 0.65 mm2/year; p = 0.44) or between study and partner eyes (p = 0.86). Over a mean time of 3.64 ± 2.73 years, a mean of 8.3 ± 2.8 anti-VEGF injections were given. No correlation between the amount of anti-VEGF injections and change in growth rate could be observed (r = 0.58; p = 0.23). Conclusion In this pilot study, primary GA enlargement did not seem to be influenced by a secondary CNV. No association between the intensity of anti-VEGF treatment and changes in atrophy enlargement rates were found. Further studies with larger sample sizes are warranted.

scholarly journals The impact of depression on survival of Parkinson's disease patients: a five-year study

2013 ◽  
Vol 62 (1) ◽  
pp. 8-12 ◽  
Author(s):  
Cláudia Débora Silberman ◽  
Cláudia Soares Rodrigues ◽  
Eliasz Engelhardt ◽  
Jerson Laks
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cox Regression ◽  
Rank Test ◽  
First Year ◽  
Kaplan Meier ◽  
Significant Difference ◽  
The Impact ◽  
Mean Time

OBJECTIVE: The aim of this study is to evaluate the survival rate in a cohort of Parkinson's disease patients with and without depression. METHODS: A total of 53 Parkinson's disease subjects were followed up from 2003-2008 and 21 were diagnosed as depressed. Mean time of follow up was 3.8 (SD 95% = 1.5) years for all the sample and there was no significant difference in mean time of follow up between depressed and nondepressed Parkinson's disease patients. Survival curves rates were fitted using the Kaplan-Meier method. In order to compare survival probabilities according to the selected covariables the Log-Rank test was used. Multivariate analysis with Cox regression was performed aiming at estimating the effect of predictive covariables on the survival. RESULTS: The cumulative global survival of this sample was 83% with nine deaths at the end of the study - five in the depressed and four in the nondepressed group, and 55.6% died in the first year of observation, and none died at the fourth and fifth year of follow up. CONCLUSION: Our finding point toward incremental death risk in depressed Parkinson's disease patients.

scholarly journals A Prospective Randomized Study of the Safety and Efficacy of Transforaminal Lumbar Interbody Fusion Versus Posterior Lumbar Interbody Fusion in the Treatment of Lumbar Spondylolisthesis: A Cost utility from a Lower-middle-income Country Perspective and Review of Literature

2021 ◽  
Vol 9 (B) ◽  
pp. 636-645
Author(s):  
Nasser El-Ghandour ◽  
Mohamed Sawan ◽  
Atul Goel ◽  
Ahmed Assem Abdelkhalek ◽  
Ahmad M. Abdelmotleb ◽  
...  
Keyword(s):  
Interbody Fusion ◽  
Posterior Lumbar Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Cost Utility ◽  
Lumbar Interbody Fusion ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
The Mean ◽  
Lumbar Spondylolisthesis

BACKGROUND: The safety and efficacy of transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) in lumbar spondylolisthesis have not been validated in many prospective randomized trials. AIM: We aimed to validate the safety and efficacy of TLIF and PLIF surgery in lumbar spondylolisthesis using the clinical, radiographic, and cost-utility outcomes. METHODS: The data of surgically treated single-level spondylolisthesis patients were randomized prospectively into two groups. The groups were compared regarding demographics, perioperative complications, hospital stay, total expenditure, fusion rate, and clinical outcomes (visual analog scale, Oswestry disability index, Zurich claudication scale, and Odom’s criteria). A review of literature was done to compare the outcomes with the ones from higher-income nations. RESULTS: Thirty-three patients underwent prospective randomization. The improvement in the clinical outcomes at 12-month follow-up showed improvement in the TLIF group more than the PLIF group but with no significant difference. The mean operative time was significantly longer in the PLIF (p < 0.05), also, the blood loss was significantly less in the TLIF (p < 0.001). The complications frequency did not show any statistical significance between both groups and no significant difference in the patient’s post-operative patient satisfaction (p = 0.6). The mean hospital stay was non-significantly longer in the PLIF (p = 0.7). At 12-month follow-up, 93.3% of the TLIF patients were fused versus 86.7% of the PLIF (p = 0.5). The total cost of the TLIF was significantly less (p < 0.001). CONCLUSION: Both PLIF and TLIF could achieve similar fusion rates and clinical satisfaction in the management of lumbar spondylolisthesis. The TLIF group was significantly better in terms of financial burden, operative time, and blood loss.

Abstract W P299: Impact of an Institutional Guideline on Implementing Early Decompressive Hemicraniectomy (DHC) for Large Middle Cerebral Artery Stroke

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Casey Olm-Shipman ◽  
Victoria Marquevich ◽  
Jonathan Rosand ◽  
Aman Patel ◽  
Emad Eskandar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Guideline Implementation ◽  
Rapid Identification ◽  
Decompressive Hemicraniectomy ◽  
Significant Difference ◽  
Class 1 ◽  
Before And After ◽  
The Impact ◽  
Mean Time

Background: Recent AHA Acute Stroke Guidelines endorse DHC (Class 1, Level B) based on clinical trials showing benefit of early DHC on outcome and mortality. In 2011, our multidisciplinary quality improvement team developed a process to translate DHC guideline recommendations into clinical practice. Methods: Our consensus guideline includes a tool (STATE Criteria, based on inclusion/exclusion criteria of DHC clinical trials) to rapidly identify and triage potential DHC candidates, and provide specific guidelines for pre- and post-surgical management, adjunctive therapy, and DHC after IV/IA thrombolysis. Patients meeting all STATE Criteria including age ≤ 60 years are sent for urgent DHC. Patients meeting all criteria except age ≤ 60 years receive DHC only if age < 75 years and Neurology and Neurosurgery teams reach consensus about benefit. Patients not meeting criteria are observed and referred for DHC if criteria are met within 48 hours of onset. The guideline was disseminated to all stakeholders via email, conferences, and intranet. In this study, we retrospectively analyzed process and outcome measures for DHC before and after guideline implementation in February 2011. Results: Of 1518 stroke patients age ≤ 60 years admitted between January 2007 and April 2014, 47 (3%) received DHC (22 pre- and 25 post-guideline implementation; 28% female, 13% Hispanic). Mean admission NIHSS was similar (17±7 vs 18±5; p=.82). Mean time from admission to DHC improved significantly from 45±30 hours to 29±18 hours (p=0.04). The percentage of patients undergoing DHC beyond 48 hours decreased from 27% to 16% (p=0 .35). The degree of midline shift evident on CT or MRI prior to DHC significantly decreased from 9±4 mm to 5±4 mm (p=.01). There was no significant difference in length of stay, frequency of tracheostomy, gastrostomy, pneumonia, or urinary tract infection, or percentage of patients who died within 30 days of DHC. Conclusion: Our institutional guideline has facilitated the rapid identification and triage of patients with large MCA stroke to DHC. Follow-up is ongoing to determine the impact of our guideline on functional outcome after stroke.

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