nitinol and Otosclerosis

The aim of this study is to perform a systematic review and meta-analysis of observational studies in which hearing outcomes after primary stapes surgery have been reported. After the surgical procedure, the effectiveness of stapes surgery using nickel titanium (Nitinol) or other prostheses were systematically compared and evaluated using a meta-analytic method. A systematic search for articles before January 2017 in Embase, Medline and Cochrane Library databases was conducted. Only articles in English were included. Inclusion criteria for qualitative synthesis consisted of a population of otosclerosis patients, intervention with primary stapes surgery using the Nitinol heat-crimping prosthesis compared with other type of stapes stapedotomy prostheses, and hearing outcome. Inclusion criteria for quantitative analysis consisted of application of audiometry guidelines of the American Academy of Otolaryngology Head and Neck Surgery Committee on Hearing and Equilibrium for evaluation of conductive hearing loss. A postoperative air-bone gap (ABG) ≤ 10 dB was considered effective. A bias assessment tool was developed according to Cochrane guidelines. To evaluate the mean age of the samples we used the chi-square test. Of the 4926 papers identified through the electronic database search (3695 in Pubmed/Cochrane and 1231 in Embase), 540 studies matched the selection criteria (436 in Pubmed/Cochrane and 104 in Embase) after application of filters and elimination of duplicate articles. After analysis of the title and abstract, 459 were excluded (396 in Pubmed/Cochrane and 63 in Embase). Of the remaining 81 papers, 74 were excluded according to the study selection criteria. A total of seven eligible studies with 1385 subjects, consisting of 637 in the Nitinol group and 748 in the non-Nitinol group, were included in our study. There were statistically significant differences in the effectiveness of stapes surgery between the Nitinol and non-Nitinol prostheses; the data showed a combined odds ratio (OR) of 2.56 (95% CI 1.38-4.76, p = 0.003). There were no statistically significant differences in the mean pre-operative age between Nitinol and non-Nitinol prostheses (p = 0.931). Our results suggest that the effectiveness of Nitinol was higher than non-Nitinol prostheses, with superiority of the number of patients with ABG ≤ 10 dB.. Protesi Nitinol vs non-Nitinol nella chirurgia dell’otosclerosi: meta-analisi.. Scopo di questo studio è stato quello di fare una revisione sistematica ed una meta-analisi di studi osservazionali in cui venivano riportati risultati audiologici dopo chirurgia stapediale. Dopo la procedura chirurgica, sono stati sistematicamente analizzati con metodo meta analitico i risultati di efficacia della chirurgia stapediale usando protesi Nitinol o altre protesi. È stata fatta una ricerca sistematica dei lavori sui database Embase, Medline e Cochrane Library prima del Gennaio 2017. Sono stati considerati solo articoli in lingua inglese. Il criterio di inclusione per una sintesi qualitativa era una popolazione di pazienti otosclerotici, sottoposti a chirurgia stapediale primitiva usando la protesi Nitinol, confrontati con altri tipi di protesi, paragonandone gli outcome funzionali. I criteri di inclusione per un’analisi quantitativa consistevano nell’ applicazione delle linee guida dell’American Academy of Otolaryngology Head and Neck Surgery Committee on Hearing and Equilibrium per la valutazione della perdita trasmissiva. Il gap post-operatorio aria-osso ≤ 10 Db è stato considerato efficace. Uno strumento di evidenza dei bias è stato sviluppato in accordo con le linee guida Cochrane. Per valutare l’età media del campione abbiamo usato il test chi-quadro. Dei 4926 lavori identificati attraverso la ricerca elettronica (3695 in Pubmed/Cochrane e 1231 in Embase), 540 lavori rispondevano ai criteri di selezione (436 in Pubmed/Cochrane and 104 in Embase) dopo l’applicazione dei filtri e l’eliminazione di articoli doppi. Dopo l’analisi di titolo ed abstract, 459 sono stati esclusi (396 in Pubmed/Cochrane e 63 in Embase). Dei rimanenti 81, 74 sono stati esclusi in base ai criteri di selezione dello studio. Un totale quindi di sette studi con 1385 pazienti, di cui 637 nel gruppo Nitinol e 748 nel gruppo non Nitinol, sono stati inclusi nel nostro lavoro. Vi erano differenze statisticamente significative sull’efficacia della chirurgia stapediale fra le protesi Nitinol e non Nitinol; i dati hanno dimostrato un odds ratio (OR) di 2,56 (95% IC 1,38-4,6, p = 0,003). Non vi sono state differenze statisticamente significative nell’età media preoperatoria fra le protesi Nitinol e non Nitinol (p = 0,931). I nostri risultati suggeriscono che l’ efficacia delle protesi Nitinol è maggiore di quelle non Nitinol.

Topics: Alloys; Humans; Observational Studies as Topic; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Stapes Surgery

To perform a systematic review of observational studies reporting hearing outcome in primary stapes surgery where a heat-crimping prosthesis was used.. Medline, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, TRIP database, Clinical Trials Registry, ISI Web of Knowledge, and Web of Science. The search was performed on January 1, 2010, including articles published ahead of print. No language restrictions.. Inclusion criteria for qualitative synthesis were a population of otosclerosis patients, intervention being primary stapes surgery with a nickel titanium alloy (Nitinol) heat-crimping prosthesis, and hearing outcome. Inclusion criteria for quantitative analysis: application of audiometry guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium for evaluation of conductive hearing loss.. Strategy and reporting based on Cochrane, Quality of Reporting of Meta-analyses, and Meta-analysis of Observational Studies in Epidemiology statements. A bias assessment tool was developed according to Cochrane guidelines.. A quantitative synthesis was performed, but because of the heterogeneity in postoperative follow-up periods and outcome measures reported, we were not able to pool these data. A sample size analysis was performed to indicate the sample needed to demonstrate a statistically significant difference in hearing outcome between both interventions. Hearing outcome superiority of the Nitinol heat-crimping prosthesis over manually crimping prosthesis types was not demonstrated.. Superiority could probably not be demonstrated because of insufficient sample size. Research addressing technical improvements in stapes surgery should agree on a base sample size able to detect the smallest difference that is clinically important or accept the null hypothesis. With data gathered in the Common Otology Database as basis, a sample size of at least 413 patients is needed in both the intervention and the control group. Other clinical outcome measures also should be explored.

Topics: Alloys; Humans; Ossicular Prosthesis; Otosclerosis; Prosthesis Implantation; Stapes Surgery; Treatment Outcome

The aim of this study is to determine differences in postoperative air-bone gap (ABG) after placement of teflon-platinum or nitinol middle ear prostheses in primary stapedotomy patients with otosclerosis. Thirty otosclerosis patients (24 female, 6 male; age 10-61 years) with primary stapedotomy were studied prospectively. Before and after surgery, the mean and standard deviations of the ABG were measured at eight frequencies (0.25-4 kHz). Patients were randomized into one of two groups receiving either teflon-platinum or nitinol prostheses. Hearing results were assessed 1 year after surgery. To assess the joint influence of treatment and frequency on ABG reduction, a linear mixed model was used (significance level was p = 5%). The Tukey-Kramer method was used to adjust for multiple comparisons. Significant differences were found between treatment groups (p < 0.0001) and between frequencies within the same treatment group (p < 0.0001) but no interaction (p = 0.7963), i.e. the reduction of the conductive components over frequencies was nearly parallel in both groups. Overall, patients in the Teflon group had a larger reduction of conductive components, on average 8.0 dB more reduction, than patients in the nitinol group. However, after adjusting for multiple comparisons, we could not identify a single frequency with a significant difference in reduction of conductive components. Use of the teflon-platinum prosthesis results in statistically non-significant better ABG closure at 0.25-4 kHz 1 year postoperatively than the use of the nitinol prosthesis.

Topics: Adolescent; Adult; Alloys; Child; Ear, Middle; Female; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Platinum; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Stapes Surgery

The aim of this study was to determine the efficacy of a shape-memory alloy, Nitinol, as a component of an improved stapes prosthesis.. Prospective laboratory and clinical study to develop a Nitinol stapes prosthesis.. Various diameters of Nitinol wire and temperature transition variants were analyzed with regard to ease of deformation, response to heating, and strength. The size and geometry of the closed hook was determined by measurement of 50 incus cadaver bones. Several heat sources for activating the shape memory were evaluated, including electrocautery, lasers, and warm water. Trial surgeries were then performed on human temporal bones in the laboratory. The closure characteristics of the Nitinol loop were studied. Magnetic resonance imaging (MRI) testing at 1.5 Tesla was performed to determine safety during MRI studies. Preliminary human subject trials were then instituted.. In all cases, a low heat condition was ample to activate the shape memory characteristics of the hook and return it to a closed position after it had been opened. Laser power was generally set well below the power needed for removing bone. The Nitinol loop closed snugly around the incus with application to the top of the hook with a low temperature laser setting. Almost any heat source was effective. MRI testing at 1.5 Tesla showed no movement of the prosthesis. Preliminary results in human subjects showed excellent air-bone closure. The Nitinol loop holds uniform contact around the incus.. The Nitinol piston greatly simplifies the stapedectomy procedure by taking the need for a hand operated instrument out of the surgeon's hands. Because of the nature of the Nitinol wire, it can never over-crimp. All these characteristics make the prosthesis advantageous for otosclerosis surgery.

Topics: Alloys; Cadaver; Female; Follow-Up Studies; Humans; Incus; Magnetic Resonance Imaging; Male; Ossicular Prosthesis; Otosclerosis; Prospective Studies; Prosthesis Design; Prosthesis Implantation; Recovery of Function; Risk Assessment; Stapes; Stapes Mobilization; Treatment Outcome

To statistically analyse the hearing thresholds of two cohorts undergoing stapedotomy for otosclerosis with two different prostheses.. A retrospective study was conducted comparing NiTiBOND (n = 53) and Nitinol (n = 38) prostheses.. Average follow-up duration was 4.1 years for NiTiBOND and 4.4 years for Nitinol prostheses. The post-operative air-bone gap was 10 dB or less, indicating clinical success. The p-values for differences between (1) pre- and post-operative values in the NiTiBOND group, (2) pre- and post-operative values in the Nitinol group, (3) pre-operative values and (4) post-operative values in the two groups were: air-bone gap - p < 0.001, p < 0.001, p = 0.631 and p = 0.647; four-frequency bone conduction threshold - p = 0.076, p = 0.129, p < 0.001 and p = 0.005; four-frequency air conduction threshold - p < 0.001, p < 0.001, p = 0.043 and p = 0.041; three-frequency (1, 2 and 4 kHz) bone conduction threshold pre-operatively - p = 0.639, p = 0.495, p = 0.001 and p = 0.01; and air conduction threshold at 4 kHz: - p < 0.001, p < 0.001, p = 0.03 and p = 0.058.. Post-operative audiological outcomes for NiTiBOND and Nitinol were comparable.

Topics: Adult; Aged; Alloys; Audiometry; Auditory Threshold; Bone Conduction; Female; Hearing; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Postoperative Period; Prosthesis Design; Retrospective Studies; Stapes Surgery; Treatment Outcome; Young Adult

To analyze health-related quality of life (HRQoL) and audiological results after stapes surgery using a Nitinol Head Prosthesis (NHP).. Study-Design Prospective longitudinal study. Patients Patients undergoing stapes surgery for otosclerosis and stapes reconstruction with a NHP between January 2018 and December 2018 (n = 48). Intervention Audiological measurements preoperatively and at 6 months follow-up as well as two questionnaires assessing HRQoL, i.e., the Stapes Plasty Outcome Test 25 (SPOT-25) and the Glasgow Benefit Inventory (GBI). Main outcome measures Correlation of pure tone average (4PTA 0.5-3 kHz) with questionnaires assessing HrQOL preoperatively and at follow-up after stapes surgery.. Patients showed a significantly reduced air-bone-gap (ABG, 0.5, 1, 2, 3 kHz) at the follow up visit (median: 11.3 dB, IQR 5.0-14.4) compared to the preoperative measurements (median 27.5 dB, IQR 21.9-36.3). Disease-specific HRQoL improved significantly in all scales of the SPOT-25 apart from the subscore "tinnitus". Postoperatively, the subscore "hearing function" correlated well only with the ABG (r = 0.59, p = 0.001). The SPOT-25 and GBI total scores showed a moderate negative correlation (r = - 0.59, p = 0.008).. Stapes surgery leads to significant improvements of hearing and the HRQoL. However, correlations between HRQoL questionnaire scores and the audiometric outcomes were inconclusive, indicating that the use of HRQoL measures for the assessment of stapedotomy outcomes to complement objective outcomes should be encouraged.

Topics: Adult; Alloys; Audiometry; Biocompatible Materials; Female; Follow-Up Studies; Hearing Loss; Hearing Tests; Humans; Longitudinal Studies; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prospective Studies; Prosthesis Implantation; Quality of Life; Stapes Surgery

To assess long-term hearing outcomes following stapedectomy using a self-crimping shape memory nitinol prosthesis. The results were compared with those of a group of patients who received a conventional prosthesis.. Retrospective case review.. Tertiary referral center.. All patients who underwent stapedectomy for otosclerosis between July 2001 and November 2008 with a minimum dataset of preoperative, early postoperative (≤2 yr), and late postoperative (≥6 yr) audiometry were included. Fifty-six patients with a nitinol prosthesis and 27 patients with a titanium prosthesis met the inclusion criteria.. Stapedectomy using a nitinol or conventional prosthesis.. Hearing outcomes by audiological assessment.. Mean duration of follow up was 9.5 (standard deviation [SD] 1.4) years in the nitinol group and 12.6 (SD 2.1) years in the titanium group. The early and late mean postoperative air-bone gaps (ABGs) were 9.7 and 9.8 dB in the nitinol group and 11.0 and 12.6 dB in the titanium group, respectively. The proportion of patients achieving an ABG less than or equal to 20 dB at early and late follow up was 96% and 96% in the nitinol group and 92% and 86% in the titanium group respectively.. The excellent closure of the ABG achieved at early follow up remains remarkably stable up to 12 years using a self-crimping shape memory nitinol prosthesis. There is no evidence that firm fixation of the hook around the long process of incus has a detrimental effect in the long-term.

Topics: Adult; Alloys; Female; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Implantation; Retrospective Studies; Stapes Surgery

Stapes plasty is an established procedure to improve hearing in case of otosclerosis. By reinforcing the prostheses, an optimization of the prosthesis could be achieved. The aim of the study was to evaluate the audiological results of the Nitinol Superelastic stapes prosthesis compared with a Platin-Teflon prosthesis.. In a retrospecitve setting, the audiological results of nine patients who have been implanted with a Nitinol Alloy Superelastic stapes prothesis were compared with the results of ten patients, which have been implanted with a Platinum-Teflon piston prostesis. All operations were performed by the same experienced ear surgeon.. The Nitinol-group presented an average of postoperative air-bone-gap over all frequencies (0.5-6 kHz) of all patients of 15.1 dB. In the Platin-Teflon group, the average of postoperative air-bone-gap was 14.9 dB. Moreover, the post surgery delta-bone-conduction pre- to post surgery showed no differences (0.5-6 kHz). There were no surgical complications in both groups.. Based on the patient collective, stapes plasty using a Nitinol Superelastic stapes prosthesis is a sufficient method for improving the hearing conduction.. Retrospective case series.. University Department.

Topics: Adult; Aged; Alloys; Bone Conduction; Female; Hearing Loss, Conductive; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Platinum; Polytetrafluoroethylene; Postoperative Period; Prosthesis Design; Prosthesis Implantation; Retrospective Studies; Stapes; Stapes Surgery; Treatment Outcome

Otosclerosis is an inner ear bone disease characterized by fixation of the stapes and consequently progressive hearing loss. One treatment option is the surgical replacement of the stapes by a prosthesis. When so called "smart materials" like nitinol are used, prosthesis fixation can be performed using a laser without manual crimping on the incus. However, specific laser-prosthesis interactions have not been described yet. The aim of the present study was to elucidate the thermo-mechanical properties of the NiTiBOND® prosthesis as a basis for handling instructions for laser-assisted prosthesis fixation.. Closure of the NiTiBOND® prosthesis was induced ex vivo by either a diode laser emitting at λ = 940 nm or a CO. Especially the diode laser was found to be an appropriate energy source. A total energy deposit of 60 mJ by pulses in near contact application was found to be sufficient for prosthesis closure ex vivo. Energy should be transmitted through a laser fiber equipollent to the prosthesis band diameter. Specific deformation characteristics due to the zonal prosthesis composition have to be taken into account.. NiTiBOND® stapes prosthesis can be closed by very little energy when appropriate energy sources like diode lasers are used, suggesting a relatively safe application in vivo. Lasers Surg. Med. 50:153-157, 2018. © 2017 Wiley Periodicals, Inc.

Topics: Alloys; Equipment Design; In Vitro Techniques; Laser Therapy; Lasers, Semiconductor; Materials Testing; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Prosthesis Implantation; Stapes Surgery

Topics: Adult; Alloys; Female; Hearing; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Prosthesis Implantation; Retrospective Studies; Stapes Surgery; Treatment Outcome

Coupling of the prosthesis to the long process of the incus is a critical step in stapes surgery. We report first experiences with the NiTiFLEX® stapes prosthesis, a further development of the Soft CliP® stapes prosthesis (Kurz, Dusslingen, Germany). Instead of pure titanium, the CliP® now consists of nitinol, a superelastic nickel-titanium alloy. This further reduces the pressure exerted on the long process of the incus, aiming to improve coupling and minimize the risk of incus luxation.. In a monocentric, retrospective cohort study, we evaluated air-bone gap reduction (4PTA0.5-4 kHz), understanding of monosyllables at 65 and 80 dB SPL stimulation levels, and adverse effects, such as changes in bone conduction (4PTA0.5-4 kHz). During a 12-month period (May 2014 to April 2015), stapes surgery was performed in 21 otosclerosis patients using the NiTiFLEX® prosthesis. The footplate was perforated using a CO2 laser (scanning mode; 0.7 mm; 20-21 W) in almost all cases. The diameter of the titan piston was 0.4 mm. Immersion at an angle of almost 90° thus results in a gap between the footplate perforation and the piston of 0.15 mm. Positioning onto the long incus process was performed with a 90°microhook (0.6 mm).. In all cases the NiTiFLEX® stapes prosthesis was inserted without complications. The mean bone conduction threshold did not change significantly postoperatively and the mean air-bone gap (4PTA0.5-4 kHz) improved on average from 29.0 to 9.5 dB HL. Handling of the prosthesis was rated as very good.. The limited experience of this study suggests that the NiTiFLEX® stapes prosthesis is a successful further development of the Soft CliP® technique with very good intraoperative handling qualities. While long-term results from larger studies are needed, this case series demonstrates that the hearing outcome is comparable to other prostheses.

Topics: Adult; Alloys; Elastic Modulus; Equipment Failure Analysis; Female; Hearing Loss, Conductive; Humans; Male; Middle Aged; Ossicular Prosthesis; Ossicular Replacement; Otosclerosis; Pilot Projects; Prosthesis Design; Retrospective Studies; Stapes Surgery; Surgical Instruments; Titanium; Treatment Outcome

To compare audiometric and functional outcomes between two designs of heat-activated self-crimping stapes prostheses-a modified shape memory circumferential nitinol-Teflon piston versus its predecessor-in patients with otosclerosis.. A retrospective analysis of preoperative and postoperative hearing thresholds.. Tertiary referral center and teaching hospital.. One hundred sixty-three consecutive procedures of primary stapes surgery for clinically proven otosclerosis in 108 women and 55 men with an average age of 46 years.. Stapedotomy and insertion of either a standard or a circumferential stapes prosthesis.. Four-frequency pure-tone average preoperative and postoperative air-bone thresholds were recorded. A secondary outcome measure was stability of the implant, as measured by failure rates.. Success of closure of the air-bone gap to within 10 dB was achieved in 97% and comparable in both groups (original prosthesis, 23.6; standard deviation, 7.3, with the average reduction seen in the circumferential prosthesis group being 22.6, standard deviation, 5.6). All the differences were not statistically significant using two-way analysis of variance. Failure rate for the original piston was 6%, with no failures seen with the circumferential piston.. Both prostheses showed comparable postoperative hearing outcomes, with the circumferential prosthesis being found to be more stable.

Topics: Adult; Aged; Alloys; Audiometry; Audiometry, Pure-Tone; Bone Conduction; Female; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Polytetrafluoroethylene; Prosthesis Design; Prosthesis Failure; Prosthesis Implantation; Retrospective Studies; Stapes Surgery; Treatment Outcome

Compared to traditional stapes prostheses, self-crimping prostheses have been shown to result in similar, if not better, closure of the air bone gap in patients undergoing stapedotomy for otosclerosis. To achieve self-crimping, nitinol, a shape memory alloy, has been used for several years but concerns have been raised regarding possible damage to the incus and its muco-periosteum. We investigate these concerns with regard to the newer NiTiBOND stapes prosthesis in an observational multi-centre study.. In a multicentre, prospective observational study, 76 patients undergoing stapedotomy with the NiTiBond prosthesis across 4 centres were compared to 75 -retrospectively selected control SMart patients. Complications, intra-operative user-friendliness and audiological results at 3 months were documented.. Audiological improvement and the rate of complications were similar in both groups. Non inferiority was shown at all frequencies and in the pure-tone average. The NiTiBOND prosthesis was described as very user-friendly.. By eliminating manual crimping, stapedotomy using the NiTiBOND prosthesis can be facilitated and standardized. Furthermore, intraoperative handling characteristics of the prosthesis are very good which may further reduce operative risk. Importantly, we show that these benefits are not to the detriment of audiological outcome. Larger and longer-term studies are required to further evaluate results.

Topics: Adolescent; Adult; Aged; Alloys; Audiometry, Pure-Tone; Auditory Threshold; Bone Conduction; Child; Female; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Retrospective Studies; Titanium; Young Adult

To evaluate the long-term (5-year) results of the shape-memory nitinol stapes piston in the surgical treatment of otosclerosis.. Retrospective case review in a tertiary referral center.. The patients were adults with clinically proven otosclerosis undergoing stapedotomy. Stapedotomy and ossicular chain reconstruction using a shape-memory nitinol stapes piston were performed. The main outcome measure was masked air and bone conduction audiometry.. Forty-eight out of a potential 58 ears had complete audiometric data. The mean preoperative air-bone gap was 29.2 dB (standard deviation [SD] 9.4). The postoperative gap at 1 year was 4.6 dB (SD 3.1), and P at 5 years was 7.0 dB (SD 6.2).. These data suggest that the Smart piston provides a stable long-term hearing result in the surgical treatment of otosclerosis.

Topics: Adult; Alloys; Analysis of Variance; Audiometry, Pure-Tone; Auditory Threshold; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Failure; Retrospective Studies; Severity of Illness Index; Stapes Surgery; Time Factors; Treatment Outcome; United Kingdom

Analysis of 12-month midterm clinical and audiometric data of patients with otosclerosis who underwent stapedotomy using a newly designed prosthesis made of nitinol, a shape memory alloy.. Fifty-five ears of 50 consecutive patients who underwent stapetotomy between March 2010 and July 2011 were included. They met the inclusion criteria of primary procedures, a clinical follow-up and absence of nickel allergy.. Stapedotomy and insertion of a newly designed stapes prosthesis.. Preoperative and postoperative (3 and 12 mo) air and bone conduction thresholds were recorded. Pure tone average and air bone gap (difference of air and bone conduction thresholds) were calculated for 500, 1,000, 2,000, and 3,000 Hz. The occurrence of complications was assessed.. Air conduction thresholds, pure tone average, and air-bone gap improved significantly 3 and 12 months postoperatively. Bone conduction threshold improved significantly at 2,000 Hz 3 months postoperatively and at 1,000 and 2,000 Hz 12 months postoperatively. A PTA of less than 20 dB was achieved in 96% of ears. No sensorineural hearing loss or other prosthesis-related adverse effects were observed.. Postoperative hearing results are comparable to the results obtained with other self-crimping prostheses. No complications or failures related to the prosthesis occurred. A longer follow-up is necessary to prove long-term stability of hearing results and safety of the new prosthesis.

Topics: Adult; Alloys; Anesthesia, General; Audiometry; Audiometry, Pure-Tone; Bone Conduction; Cochlear Implants; Female; Humans; Male; Middle Aged; Otosclerosis; Postoperative Period; Prosthesis Design; Prosthesis Implantation; Stapes Surgery; Treatment Outcome; Young Adult

Topics: Adult; Alloys; Female; Hearing Tests; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prospective Studies; Prosthesis Design; Reoperation; Stapes Surgery; Treatment Outcome

To prospectively analyze short-term (3 mo) results in patients with otosclerosis who underwent stapedotomy with the newly designed NiTiBOND prosthesis and compare them with patients that underwent SMart piston stapedotomy. We aimed to assess "noninferiority" for the new prosthesis.. Prospective controlled trial.. Tertiary referral center.. Thirty-eight patients were included in the NiTiBOND group (41 ears), and 74 patients were included in the SMart Piston group (75 ears).. Stapedotomy.. Pure-tone audiometry 3 months after surgery, intraoperative prosthesis handling as assessed using a questionnaire, and complications were analyzed.. Pure-tone audiometry showed postoperative air-bone gap means (standard deviation) of 8.1 (8.3) and 9.9 (5.4) dB; air-bone gap closure within 10 dB was achieved in 71% and 72% and within 20 dB in 93% and 96% for the NiTiBOND and the SMart piston prosthesis, respectively. Noninferiority was shown at all frequencies and in the pure-tone average. The NiTiBOND prosthesis provides excellent intraoperative handling, and no adverse reactions were reported.. Preliminary short-term results suggest safety and reliability for the new NiTiBOND stapes prosthesis.

Topics: Adult; Aged; Alloys; Anesthesia; Audiometry, Pure-Tone; Auditory Threshold; Biocompatible Materials; Equipment Design; Female; Humans; Male; Middle Aged; Monitoring, Intraoperative; Ossicular Prosthesis; Otosclerosis; Patient Satisfaction; Prospective Studies; Speech Perception; Stapes Surgery; Surveys and Questionnaires; Titanium; Treatment Outcome; Young Adult

To compare the SMart piston stapes prosthesis to a standard manual crimp prosthesis on operative time and air-bone gap (ABG) closure in stapedectomy.. Retrospective chart review.. Tertiary referral centre.. The charts of patients undergoing stapedectomy for otosclerosis were analyzed. We compared the results of 76 patients (80 ears) who received the autocrimping SMart piston prosthesis to those of 21 patients (21 ears) who received the conventional manual crimp Fisch-type prosthesis. Data were analyzed using t-test, chi-square, or two-way analysis of variance where appropriate.. Operative time with ABG closure as a secondary outcome measure.. There was a significant difference in operative time between the Fisch-type prosthesis and the SMart piston prosthesis groups. The operation required 28.9 ± 3.2 minutes when using the Fisch-type prosthesis, whereas 21.2 ± 2.4 minutes were needed when using the SMart piston (p < .001). There was a significant improvement in postoperative ABG for both the Fisch-type piston (28.1 ± 3.1 to 9.0 ± 1.4, p < .001) and the SMart piston (25.1 ± 3.7 to 8.2 ± 2.5, p < .001) groups.. Use of the SMart piston prosthesis results in ABG closure similar to that of the traditional Fisch-type prosthesis but offers the added advantage of reduced operative time.

Topics: Adult; Aged; Alloys; Audiometry; Cochlear Implants; Female; Follow-Up Studies; Hearing; Humans; Male; Middle Aged; Otosclerosis; Prosthesis Design; Retrospective Studies; Stapes Surgery; Treatment Outcome

SUPERELASTIC NITINOL STAPES PROSTHESESINTRODUCTION: Many different prostheses are available for stapes surgery. The newly designed Nitinol piston band-shaped stapes prosthesis could minimize postoperative complications due to its new superelastic characteristic and design.. A stapedectomy and implantation of superelastic Nitinol piston stapes prosthesis was performed in 22 patients with a mean age of 45.2 years. Examination and audiometry was performed pre- and postoperatively.. The average observed air-bone-gap in all frequencies was 12.8 dB postoperatively, whereas in the frequencies 0.5-4 kHz ABG was under 10 dB in 68.2% of the patients, between 10 and 15 dB in 18.2% and between 15 and 20 dB in 9.1% of the patients. No patient showed air-bone-gap of more than 20 dB. One patient missed follow-up examination.. In stapes surgery the step of fixation of the prosthesis onto the incus is critical. Implantation of the new Nitinol piston stapes prosthesis is facilitated due to the superelasticity and the design of the prosthesis. Crimping is not needed anymore. Postoperative hearing results are very good comparable to other Nitinol (shape memory) or titanium prostheses. Long-term results in a larger number of patients will be studied in the future.

Topics: Adult; Alloys; Audiometry, Pure-Tone; Auditory Threshold; Elasticity; Female; Follow-Up Studies; Hearing Loss, Conductive; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Prosthesis Fitting; Stapes Surgery

A growing number of studies conducted on stapes surgery have suggested that firm and adequate attachment of the prosthesis onto the long process of the incus plays a key role in surgical success. For this reason, a new prosthesis made of Nitinol characterized by "self-crimping" has been developed. Although better postoperative outcomes achieved with a Nitinol piston have been previously confirmed, the superiority of the Nitinol piston over the conventional manual-crimping prostheses remains controversial. The aim of this study was to determine the advantages of the Nitinol piston with regard to hearing improvement.. We retrospectively compared postoperative hearing in otosclerosis surgeries with the Nitinol piston versus the manual-crimping prostheses. Sixteen surgeries with Nitinol pistons (carried out between April 2007 and August 2009) and 21 surgeries with conventional prostheses (carried out between January 2004 and January 2009) were evaluated. All patients received pure-tone audiograms preoperatively and postoperatively.. In the Nitinol piston group, the air-bone gap (ABG) average (7.92 + or - 6.75 dBHL) was significantly smaller postoperatively than preoperatively (26.79 + or - 8.33 dBHL, p < 0.001). Similarly, the ABG average for the conventional piston group (13.09 + or - 6.99 dBHL) was significantly smaller postoperatively than preoperatively (26.19 + or - 6.76 dBHL, p < 0.001). Although both groups demonstrated an improvement in average ABG postoperatively, the Nitinol piston group showed a greater improvement than the conventional piston group (p = 0.018). Additionally, ABG closure within 10 dB was attained in significantly more patients (75%) in the Nitinol piston group compared with the conventional piston group (33.3%, p = 0.012).. The Nitinol piston has a distinct advantage over conventional prostheses, providing an easier, safer and more effective treatment option in otosclerosis surgery. To our knowledge, this is the first comparative analysis of hearing results of the Nitinol piston with conventional prostheses in the Chinese population in Taiwan. In this population, there is a much lower prevalence of otosclerosis, leading to a lack of surgical experience in otosclerosis surgery, even at large medical centers. This may explain, in part, the relative lack of studies conducted on stapes prostheses in Asian patients. Therefore, our preliminary research may provide a reference for future investigations on stapes surgery in Asian patients with otosclerosis based on ethnic differences.

Topics: Adult; Alloys; Female; Humans; Male; Materials Testing; Middle Aged; Ossicular Prosthesis; Otosclerosis; Retrospective Studies; Stapes Surgery

To assess the hearing outcomes achieved with a Nitinol heat-crimping prosthesis when used with a laser-assisted stapedotomy for otosclerosis.. Prospective assessment of 50 stapedotomies performed in 48 patients. Data collected included audiological results and duration of hospital admission. Outcomes were compared with a previously reported series of 66 stapedotomies performed in 59 patients.. Tertiary referral center and private practice.. In the Nitinol group, hearing was improved in all cases (100%). The air-bone gap (ABG) was closed to within 10 dB in 48 (96%). This group's results are significantly better (P < or = 0.01) than those of the platinum fluoroplastic group, in whom ABG was within 10 dB in 74 percent.. Laser-assisted stapedotomy, under local anesthesia with sedation, using a Nitinol heat-crimping prosthesis is a safe, well-tolerated technique with which excellent audiological results can be achieved.

Topics: Adult; Aged; Alloys; Female; Hearing; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Platinum; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Prosthesis Implantation; Stapes Surgery; Treatment Outcome

Topics: Adult; Aged; Alloys; Audiometry, Pure-Tone; Auditory Threshold; Bone Conduction; Equipment Design; Female; Follow-Up Studies; Humans; Lasers, Solid-State; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Otoscopes; Postoperative Complications; Prosthesis Design; Prosthesis Fitting; Stapes Surgery

Compare short-term hearing outcomes with a heat-activated-crimping versus manual-crimping stapedectomy prosthesis.. Retrospective chart review.. Tertiary care neurotology referral center.. 219 charts reviewed.. Laser stapedectomy.. Audiometric.. Retrospective study comparing postoperative hearing in manual-crimp prostheses stapedectomies versus heat-activated-crimp prostheses stapedectomies.. Of the 219 patients reviewed, 94 met inclusion criteria for the study, with 47 receiving manual-crimp prosthesis and 47 receiving heat-activated-crimp prosthesis. Short-term poststapedectomy air-bone gaps, long-term air-bone gaps, long-term pure-tone averages, and long-term air-bone gap closures were significantly better for heat-activated-crimp versus manual-crimp prostheses.. Heat-activated-crimping prostheses demonstrated enhanced stapedectomy hearing outcomes versus manual-crimping prostheses on short- and long-term follow-up. Three-dimensional reorientation of the heat-activated prosthesis may enhance the hearing outcome; however, theoretical nickel allergy considerations, effects of case selection, follow-up duration, possible eventual loosening of the heat-activated crimp, and long-term incus necrosis are considerations requiring continued longitudinal analysis.

Topics: Alloys; Female; Hot Temperature; Humans; Laser Therapy; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Prosthesis Implantation; Retrospective Studies; Stapes Surgery; Treatment Outcome

Since 2003 we are using in our stapedotomies the Nitinol 'Smart' Piston. This prosthesis has a Teflon 'vestibular' end and a wire shaft made by Nitinol, with a heat activated self-crimping loop. Nitinol is an alloy of Nickel + Titanium, belonging to the class of the so-called smart materials, i.e. materials with shape-memory and superelastic properties. Nitinol is lightweight and highly biocompatible thanks to the thin layer of Titanium oxide covering the Nickel surface. The special advantage of this piston is that the loop grips by itself very uniformly and quite tightly around the incudal process or the malleus handle when a minimal heating (about 60 degrees C) is applied using a disposable heater ('Thermal Tip'). This piston was successfully used in our Department between 2003 and 2004 in a first group of 42 cases of stapedotomy and in 7 cases of malleostapedotomy. The shape and the uniformity of the loop grip was controlled by examining fresh temporal bone specimens by S.E.M. (x21 / 166) and in all specimens the loop was uniformly surrounding the ossicle, without 'dead' spaces. It is our feeling that this prosthesis is very useful in stapes surgery for at least two reasons: 1. because it improves the quality of the interface 'piston loop/long process of incus'; 2. because the duration of the procedure is reduced.

Topics: Adult; Alloys; Audiometry, Pure-Tone; Elasticity; Equipment Failure Analysis; Female; Follow-Up Studies; Heating; Humans; Male; Ossicular Prosthesis; Otosclerosis; Polytetrafluoroethylene; Prosthesis Design; Prosthesis Fitting; Stapes Surgery; Surface Properties

Recently, a new stapedotomy piston prosthesis, which is a composite metal alloy of nickel and titanium known as nitinol, has been introduced into medical use. This biocompatible alloy has the unique property of shape-memory, which permits tight self-crimping when heat is applied to the wire. To substantiate the favorable initial observations with the SMART piston, this study was undertaken to compare these results (n=26) with those obtained using conventional stainless steel or platinum ribbon prostheses (n=28).. Prospective consecutive case review: consecutive cases performed by the same surgeon were analyzed.. Tertiary referral center.. Fifty-four healthy patients with otosclerosis.. Stapedotomy using either SMART prosthesis or conventional prosthesis.. Hearing outcomes by audiological assessment.. The postoperative hearing mean pure-tone average was 24.81+/-16.20 dBHL for Group 1 (SMART prosthesis) and 27.46+/-15.57 dBHL for Group 2 (conventional prosthesis). Postoperative mean air-bone gap was 7.07+/-8.14 dBHL for Group 1 and 6.38+/-7.54 dBHL for Group 2 using 0.5-, 1-, 2-, and 4-kHz frequencies. When analyzed according to the American Academy of Otolaryngology-Head & Neck Surgery reporting criteria using an estimate of 3 kHz as a mean of the 2-and 4-kHz values, the postoperative mean air-bone gap was 5.42+/-5.4 dBHL for Group 1 SMART and 5.98+/-5.47 dBHL for Group 2 conventional prostheses. Postoperative speech discrimination scores were 96%+/-8.64% and 97%+/-5.9%, respectively. These differences were not shown to be statistically different.. Results demonstrate that experienced surgeons may achieve comparable results with both prostheses; however, the ease of self-crimping and the tightness of the crimp may provide advantages that may have long-term benefits. The potential issue of nickel allergy is important when considering patients for this prosthesis.

Topics: Adult; Aged; Alloys; Audiometry, Pure-Tone; Cochlear Implants; Evoked Potentials, Auditory, Brain Stem; Female; Hearing Loss, Sensorineural; Humans; Male; Middle Aged; Otosclerosis; Postoperative Care; Prospective Studies; Prosthesis Design; Prosthesis Implantation; Severity of Illness Index; Stapes Surgery; Stents

To review hearing results after implantation of a self-crimping stapes prosthesis.. Analysis of hearing results in patients implanted with a self-crimping stapes prosthesis at two academic hospitals from 2000 to 2004.. Seventy-nine ears were divided into short-term and intermediate follow-up groups. The mean postoperative air-bone gap (ABG), preoperative minus postoperative ABG, and preoperative minus postoperative bone conduction values were 5.7, 21.4, and 4.1 dB, respectively, for the short-term group, and 6.3, 22.3, and 4.7 dB, respectively, for the intermediate group. The ABG was <10 dB in 88 percent of the short-term group and in 79 percent of the intermediate group.. The self-crimping Nitinol stapes prosthesis provides excellent short-term and intermediate postoperative hearing results, and may overcome the limitations of stapes prostheses requiring manual crimping.. This paper provides evidence for the use of a self-crimping Nitinol stapes prosthesis, which may simplify hearing restoration surgery for stapes fixation.

Topics: Adolescent; Adult; Aged; Alloys; Audiometry; Bone Conduction; Child; Curettage; Female; Follow-Up Studies; Hearing; Humans; Laser Therapy; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Prosthesis Design; Retrospective Studies; Speech Perception; Stapes; Stapes Surgery; Treatment Outcome

To compare the hearing results in patients with otosclerosis who underwent a stapedotomy with either a platinum wire prosthesis or a commercially available, heat-activated nitinol stapes piston prosthesis.. Retrospective medical chart review.. Academic tertiary care medical center.. Seventy-nine consecutive patients diagnosed as having otosclerosis who underwent primary stapedotomy (33 men and 46 women) were included in this study (41 ears per group).. Stapedotomy.. The operative records of the senior surgeon (B.J.G.) were retrospectively reviewed, and hearing results were obtained. The hearing results of the patients who received a platinum wire prosthesis were compared with those who received a nitinol prosthesis.. Results for the platinum wire prosthesis group revealed a postoperative mean (SD) air-bone gap (ABG) of 7 (6) dB, a mean (SD) ABG closure of 21 (12) dB, and a postoperative mean (SD) speech reception threshold of 25 (16) dB. Results for the nitinol prosthesis group revealed a postoperative ABG of 8 (6) dB, an ABG closure of 25 (10) dB, and a postoperative speech reception threshold of 25 (12) dB.. These data show that the nitinol prosthesis is equivalent to the platinum wire prosthesis in closing the ABG in patients with otosclerosis. Comparable efficacy combined with the ease and safety of heat-activated crimping supports the continued use of this prosthesis for stapes surgery.

Topics: Adult; Aged; Alloys; Auditory Threshold; Female; Follow-Up Studies; Hearing Loss, Conductive; Humans; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Preoperative Care; Retrospective Studies; Severity of Illness Index; Stapes Surgery; Treatment Outcome

Development of surgical treatment of otosclerotic stapes fixation has been one of the success stories of otology for the past five decades. Nowadays not only stapedectomy and partial stapedectomy, but stapedotomy can also be considered a well established otological procedure.. To introduce this minimally invasive surgical technique into the Hungarian otolaryngology practice, to gain useful experiences, and to analyze the hearing improvements and postoperative complications.. The authors give account of their first clinical experiences with 14 patients with KTP laser assisted stapedotomies using the self-crimping Nitinol piston. A total of 14 patients (11 females, 3 males) who have undergone the procedure between March 2006 and April 2007 were reviewed. The average age of the patients was 42,2 years, 6 procedures were carried out on left ears and 8 on right ones. The average length of follow-up was 9 months (ranged from 6 weeks to 1 year).. Pure tone audiograms documented a hearing threshold improvement of 21,5 dB averaged across 0,5-1-2-3 kHz frequencies. The air-bone gap improvement averaged on the same frequencies was 18,7 dB. After an average 9 months postoperative follow-up period, the average air-bone gap was < 10 dB in 85% of the patients, however, < 20 dB in 100% of the patients. As for the average air conduction result: it was < 30 dB in each patient except for one. In this series, neither facial nerve paresis nor high frequency deterioration of the bone conduction thresholds was reported in the postoperative follow-up period.. Based on the authors' favourable experiences and the review of the literature, KTP laser assisted stapedotomy with the use of Nitinol piston has several advantages: 1) the laser-activated memory effect of the piston prevents the disadvantages of the crimping manoeuvre made around the long process of the incus; 2) vertigo, experienced in the early postoperative period is milder and takes shorter time, reducing the length of hospitalisation; 3) the procedure is cost-effective and minimally invasive; 4) application of KTP laser assures bloodless operating field and minimal cochlear trauma; 5) migration of the prosthesis can be prevented, the degree of the surrounding granulation is less; 6) high frequency hearing improvement can be achieved in the long run; 7) the frequency and seriousness of complications is less, therefore this technique can be recommended for inexperienced ear surgeons, too; 8) the procedure can be used in difficult situations, too, e.g.: in the presence of stapedial artery, obliterative otosclerosis, flooting footplate, abnormal position of the facial nerve in the middle ear, revision cases; 9) the interindividual differences of hearing results are much less. Based on their favourable initial experiences, the authors plan to conduct a long-term follow-up on greater number of patients.

Topics: Adult; Alloys; Audiometry, Pure-Tone; Auditory Threshold; Female; Hearing Loss, Conductive; Humans; Hungary; Lasers; Length of Stay; Male; Otosclerosis; Retrospective Studies; Stapes Surgery; Vertigo