Total ossicular replacement prosthesis: unusual cause of a perilymph fistula.
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Child↗
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Ossiculoplasty in young children with the Applebaum incudostapedial joint prosthesis.
OBJECTIVE: To evaluate the performance of the Applebaum incudostapedial joint prosthesis in young children in terms of hearing results and long-term stability despite continuing eustachian tube dysfunction and otitis media. STUDY DESIGN: Retrospective review of all Applebaum prostheses placed in children at our institution from June 1993 to June 1998. RESULTS: In 1993 Applebaum proposed the use of a hydroxylapatite ossicular prosthesis as an alternative to incus interposition for the repair of incudostapedial discontinuity. We have used this prosthesis exclusively for the repair of such defects in children over the past 5 years. Among 12 operated ears, all healed, all prostheses remain in place (average duration, 2.6 y), and all children have excellent hearing (mean air-bone gap, 15 dB; range, 5-25 dB). CONCLUSIONS: The Applebaum incudostapedial joint prosthesis restores conductive hearing even in young children. It has been stable in the face of recurrent otitis media and has not interfered with revision surgery. Placement of the prosthesis at primary cholesteatoma surgery should be considered in children.
Adolescent↗
A new approach for malleus/incus fixation: no prosthesis necessary.
OBJECTIVE: To describe a novel approach to manage malleus/incus fixation. STUDY DESIGN: Retrospective review of 363 patients with conductive hearing loss operated on since 1996. SETTING: Academic tertiary referral center. PATIENTS: Three hundred sixty-three patients with conductive hearing loss, an intact tympanic membrane, and without history for chronic infection underwent middle ear exploration. Three hundred forty-three had otosclerosis and underwent laser stapedotomy; the remaining 20 patients had laser release of their malleus/incus fixation. INTERVENTION: Twenty patients are presented in this paper. Nineteen patients were diagnosed with malleus fixation before surgery. One patient had a total perforation and mobility of the ossicular chain was not verified preoperatively. This patient was, intraoperatively, noted to have complete ossicular fixation. Conductive hearing loss was identified using audiometry and tuning forks. Nineteen of the 20 patients had the diagnosis confirmed using micropneumotoscopy and noting immobility of the malleus. A transcanal approach was used, and the malleus/incus fixation was released using a laser. This space was expanded upon using a drill. A 1.5-2.0 mm space was created where the ossicular fixation existed, thereby reducing the likelihood of refixation. MAIN OUTCOME MEASURE: Audiometric studies before and after intervention were compared. One to seven years of follow up are provided. RESULTS: Preoperative air-bone gaps ranged from 18 dB to 51 dB and averaged 33 dB. Postoperative air-bone gaps ranged from 1-36 dB and averaged 13 dB. No patients have experienced refixation. There were two complications: one perforation requiring a tympanoplasty and one patient sustaining a 20 dB high-frequency sensorineural loss, most likely secondary to inadvertent drill contact to the ossicular chain. CONCLUSION: When fixation of the malleus and/or incus is found, treatment options exist. A common technique involves removal of the incus and head of the malleus and reconstruction with an incus interposition or a partial ossicular prosthesis. Another technique proposed by the senior author (M.D.S.) is maintenance of the normal anatomy and use of the potassium-titanyl-phosphate laser and drill to free the ossicles and widen the epitympanum. This series shows successful closure of the air-bone gap with this technique.
Adolescent↗
[Scanning electron microscopic study of the reaction of ceramics implant in middle ear].
In this article, the reaction of ceramics implanted in cat's middle ear was observed and compared with autologous cortex bone and Teflon. The three types of graft were implanted in cat's middle ear. Then the cats were killed at one, two and four months after operation. The grafts were taken out and observed under scanning electron microscope. We found that the ceramics were coated by a continuous epithelium. Beneath this there were fibers and capillaries. These results indicated that Al2O3 ceramics are better than Teflon and is a good ossicular prosthesis.
Aluminum Oxide↗
Scanning electron microscope and energy dispersive X-ray spectrometry studies on the material surface of extruded Polycel ossicular prostheses.
BACKGROUND: The cause of ossicular prosthesis extrusion remains an issue of interest to many otologists. This study evaluated the change in material surfaces and chemical elements of extruded total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs). METHODS: A total of nine extruded Polycel ossicular prostheses (four TORPs, five PORPs) from nine patients was investigated using scanning electron microscope and energy dispersive X-ray spectrometry (EDX). Three prostheses (TORPs) obtained during revision surgery for hearing restoration were used as control subjects for EDX study. RESULTS: All subjects from the study group showed loss of fibrous capsule at both platform and shaft in the extruded prostheses. In comparison with the control group, the extruded prostheses had a lower level of carbon element (Wilcoxon signed-rank test, p < 0.05). CONCLUSION: Loss of fibrous capsule and micro-degradation are probably two of the many factors that contribute to the extrusion of ossicular prostheses.
Carbon↗
Bioglass middle ear prosthesis: long-term results.
The purpose of this study was to review the University of Florida's long-term results with Bioglass middle ear prostheses. Between April 1984 and November 1987, 37 patients were implanted with Bioglass prostheses (25 total and 12 partial ossicular replacements). Twenty-one patients had postoperative data of at least 24 months (range, 24 to 126 months; mean, 86 months; median, 100 months), and five patients had > 10 years' follow-up. In three cases, portions of fractured prostheses extruded, leaving an intact tympanic membrane. One patient with a total ossicular prosthesis was reexplored at 38 months for conductive hearing loss and found to have a prosthesis fracture (n = 1). There were no extrusions of intact prostheses, even in patients in whom the prosthesis was placed directly under the tympanic membrane or graft (n = 12). After 24 months, the mean pure-tone average air-bone gap was 24 dB (24% had ABG < or = 10 dB; 53% had ABG < or = 20 dB). Air-bone gap closures were stable over time. Our results demonstrated that Bioglass middle ear prostheses have excellent long-term tissue compatibility. The four failures are attributed to fractures in early experimental prototypes.
Audiometry, Pure-Tone↗
Electromagnetic semi-implantable hearing device: phase I. Clinical trials.
Conventional hearing aids have improved significantly in recent years; however, amplification of sound within the external auditory canal creates a number of intrinsic problems, including acoustic feedback and the need for a tight ear mold to increase usable gain. Nonacoustic alternatives which could obviate these encumbrances have not become practical due to inefficient coupling (piezoelectric techniques) or unfeasible power requirements (electromagnetic techniques). Recent technical advances, however, prompted a major clinical investigation of a new electromagnetic, semi-implantable hearing device. This study presents the details of clinical phase I, in which an electromagnetic driver was coupled with a target magnet temporarily affixed onto the lateral surface of the malleus of six hearing aid users with sensorineural losses. The results indicate that the electromagnetic hearing device provides sufficient gain and output characteristics to benefit individuals with sensorineural hearing loss. Significant improvements compared to conventional hearing aids were noted in pure-tone testing and, to a lesser degree, in speech discrimination. Subjective responses were quite favorable, indicating that the electromagnetic hearing device 1. produces no acoustic feedback; 2. works well in noisy environments; and 3. provides a more quiet, natural sound than patients' conventional hearing aids. These favorable results led to phase II of the project, in which patients with surgically amendable mixed hearing losses were implanted with the target magnet incorporated within a hydroxyapatite ossicular prosthesis. The results of this second-stage investigation were also encouraging and will be reported separately.
Acoustics↗
[Microsurgery of large middle ear abnormalities. Technical surgical considerations].
From 1988 to 1994, 75 patients with congenital aural atresias were operated on at the University ENT Department, Würzburg. Sixty-two patients (70 ears) could be followed up in their postoperative outcomes. The surgical approach used in all patients was a direct one through the atresia plate. To avoid infection and stenosis of the new meatus, a neo-tympanic membrane was built up in a far lateral position. This was possible by using a long ossicular prosthesis. The mean postoperative gain was 17.8 dB and the mean postoperative airbone gap was 31.0 dB. Twenty-two percent of the ears had postoperative infections or stenosis of the ear canal. Thirty-four percent of the ears had to undergo revision surgery. Jahrsdoerfer's grading system for congenital aural atresia showed good correlation in 64% of the ears when comparing preoperative status and postoperative outcome.
Adolescent↗
Bone cements as adjuvant techniques for ossicular chain reconstruction.
HYPOTHESIS: The osseointegrative capacity of medical-grade bone cement can be used to improve fixation and prevent displacement of an ossicular prosthesis in a guinea pig model. BACKGROUND: Successful ossiculoplasty requires a firm connection between the vibrating tympanic membrane and the inner ear. In patients requiring revision ossiculoplasty, half of failures are due to prosthesis displacement. Bone cements have been used as prosthetic material in craniofacial surgery, and their adhesive and osseointegrative properties make them ideal for use in ossicular reconstruction. METHODS: Twenty-four adult male guinea pigs underwent a postauricular surgical approach for access to the middle ear. Hydroxyapatite and Dahllite cements were used in an alternating fashion to fix ossicular bone. Four animals were killed immediately to demonstrate mechanical bonding of the ossicles at the time of application. Nineteen animals were killed 8 weeks postoperatively to assess bonding capacity and histologic inflammation. RESULTS: Both cements mechanically bonded the ossicles at the time of application, but Dahllite cement set faster in the moist environment of the middle ear space. Histologic examination showed bonding of the ossicles with both cements, with little evidence of inflammation or foreign body reaction. CONCLUSIONS: Hydroxyapatite and Dahllite bone cements showed evidence of osseointegration with ossicular bone in the guinea pig model. Further studies are under way to determine the osseointegrative capacity of Dahllite cement between the guinea pig malleus and a partial prosthesis, and any ototoxic effects with use in the middle ear.
Animals↗
Ossiculoplasty: a refined method to prepare homograft ossicles.
The purpose of this paper is to present a technique of preparing a homograft ossicular prosthesis in the most efficient and precise manner for use in ossicular reconstruction. While there are other techniques of reconstruction, this technique will benefit those surgeons who utilize homograft ossicles for hearing reconstruction. There are two major advantages of this technique. First, operating time is decreased because of preparations of the prostheses in advance. Second, the prostheses may be more precisely shaped than by other methods. The technique of preparation is not difficult and may be done by ancillary surgical personnel readily trained in this simple method.
Ear Ossicles↗
The effect of prosthesis design on vibration of the reconstructed ossicular chain: a comparative finite element analysis of four prostheses.
HYPOTHESIS: It was hypothesized that the differences in the bioacoustic performance of ossicular replacement prosthesis designs, and insertion positions, could be quantified using finite element analysis. BACKGROUND: Many designs of prosthesis are available for middle ear surgery. The materials used, and the shape of the implants, differ widely. Advances in computer simulation technologies offer the possibility of replicating the in vivo behavior of the different prostheses. If this can be achieved, insight into the design attributes required for improved biofunctionality may be gained. METHODS: Micro-computed tomography and nuclear magnetic resonance imaging were used to obtain geometric information that was translated into a finite element model of the outer and middle ear. The forced frequency response across the hearing range of the normal middle ear was compared with the middle ear reconstructed with partial and total ossicular replacement prostheses. RESULTS: The amplitude of vibration of the footplate was more similar to that of the normal ear when a Kurz total ossicular replacement prosthesis was implanted than when a Xomed total ossicular replacement prosthesis was implanted. This may be attributed to the latter's titanium link. Partial ossicular replacement prostheses were stiffest and had lower umbo vibrations and higher stapedial footplate vibrations. In all cases but one, the vibration of the prostheses had resonances that caused the vibration of the stapes footplate to be noticeably different from normal. CONCLUSION: The authors confirmed the hypothesis that finite element modeling can be used to predict the differences in the response of ossicular replacement prostheses. This study shows that computer simulation can potentially be used to test or optimize the vibroacoustic characteristics of middle ear implants.
Acoustic Impedance Tests↗
[Modification of bacterial growth by alloplastic bone substitutes].
BACKGROUND: To determine the applicability of alloplastic materials as bone substitutes it is now standard procedure to test materials for possible toxic effects and to study their behavior in animal models and cell cultures. This is especially important with respect to middle ear implants that can be put at risk by recurrent infections and require additional testing in a bacterially contaminated environment. MATERIALS AND METHODS: In the present study ionomeric cement (V-O CEM), bioactive glass ceramic and hydroxyapatite were subjected to contamination with S. aureus, E. coli, Pr. mirabilis, Ps. aeruginosa and Enterococci using agar diffusion and microbial suspension tests and examined for their antibacterial activity. A special feature of V-O CEM that had to be considered was that it could be implanted in two physical states (as a viscous substance and a fully hardened material). RESULTS: The agar diffusion test showed that an antibacterial effect of freshly mixed V-O CEM was demonstrable for up to 60 min. In the microbial suspension test growth of E. coli was found to be promoted after 48-h incubation by V-O CEM set for 1 h. S. aureus exhibited a depressed growth, while Pseudomonas cultures demonstrated cell death after 48 h. V-O CEM set for 24 h and 7 days, respectively, exerted a similar though less pronounced effect. Using the microbial suspension test, a comparison was also made of the antibacterial activities of 24-h V-O CEM, bioactive glass ceramic and hydroxyapatite against cultures of S. aureus, Pseudomonas and E. coli. The inhibitory effect of hydroxyapatite on the growth of S. aureus was found to persist beyond the 48-h incubation period. There was slight growth of E. coli in the presence of bioactive glass ceramic after 48 h, whereas hydroxyapatite produced inhibition of microbial growth. V-O CEM inhibited the growth of Pseudomonas, unlike bioactive glass ceramic and hydroxyapatite, which transiently promoted bacterial growth. DISCUSSION AND CONCLUSIONS: Our findings showed that V-O CEM, bioactive glass ceramic and hydroxyapatite exhibited material-dependent bacterial colonization and thus resembled polymeric bone substitutes (susceptible to invasion by S. epidermidis) and metals (sensitive to S. aureus). In general, users of bone substitutes should conduct preclinical tests in order to obtain advance information on the properties of possible replacement material. Since there can be varying interactions between the materials studied and bacterial growth, material-specific effects on bacterial growth should be investigated. While it is recognized that in vitro studies are an inadequate simulation of the clinical situation, they still provide some insight into the likely behavior of a bone substitutes in human sites.
Bacteriological Techniques↗
Revision ossiculoplasty.
Although ossiculoplasty, also known as ossicular chain reconstruction (OCR), was attempted initially in the early 1900s, it was not until the 1950s that it became commonplace and relatively well understood. Since then, there have been numerous technologic advances and a gain in the understanding of ossiculoplasty. However, successful OCR with resulting long-term stability can be a daunting task. Typically, the most common condition requiring revision OCR is chronic suppurative otitis media (COM) with or without cholesteatoma. Primary and revision OCR are performed also for blunt and penetrating trauma-induced conductive hearing loss, congenital defects (eg, atresia), and benign and malignant tumors. Typically, reconstruction in ears with COM is more difficult than in ears without infection. This article discusses the key factors involved in successful revision OCR.
Ear Diseases↗
Middle ear reconstructive techniques.
Middle ear reconstructive techniques have increased to such an extent that the otolaryngologist is faced with a bewildering number of surgical options. The literature, however, has yet to demonstrate any technique to be optimal in every surgical scenario. This is because of the lack of direct comparisons between techniques and dissimilar criteria for measuring success. This article uses hearing results and the ability to resist extrusion as the principle measures of success, and provides middle ear reconstructive techniques proven to be successful for commonly faced surgical dilemmas.
Ear, Middle↗
Ossicular reconstruction using bone cement.
OBJECTIVE: The objective of this study was to describe our results of ossicular reconstruction using bone cement. STUDY DESIGN: We conducted a retrospective review of 264 patients with chronic suppurative otitis media operated on since 1999. SETTING: Academic tertiary referral center. PATIENTS: : Two hundred sixty-four patients with chronic suppurative otitis media underwent mastoidectomy with tympanoplasty. Eighty patients had incudostapedial disarticulation secondary to infection and or cholesteatoma and were reconstructed using an incus interposition graft (n = 31), a partial ossicular prosthesis (POP; n = 31), or more recently, bone source (n = 18). This study evaluates the results of the ossiculoplasties using bone source. INTERVENTION: Ossicular discontinuity was repaired using bone cement. MAIN OUTCOME MEASURE: Audiometric studies pre- and postintervention were compared. One to 3 years of follow up are provided. RESULTS: Preoperative air-bone gaps ranged from 18 dB to 60 dB and averaged 33 dB. Postoperative air-bone gaps ranged from 1 to 24 dB and averaged 10 dB. No patients have experienced any increase in their persistent conductive hearing loss. The pre-/postoperative hearing loss comparisons showed statistically significant hearing improvement. There were no complications. CONCLUSION: The use of POPs and incus interposition grafts is fraught with the possibility of migration and resultant recurrent conductive hearing loss. Using bone cement to reconstruct the ossicular chain restores the integrity of the ossicular chain in the most natural of ways. This reconstruction technique provides an excellent alternative to currently accepted methods and should be considered for incus-stapes disarticulation. There has been no dissolution of the bone source and the results have persisted thus far.
Adolescent↗
Short- and long-term results of stapedectomy in children.
Studies have indicated that stapedectomy can be an effective procedure in children for correcting conductive hearing losses due to juvenile otosclerosis. However, because childhood otosclerosis is rare and children commonly choose to use hearing aids in lieu of undergoing surgery, little outcome data are available. The purpose of this retrospective study was to provide additional outcome data in both the short and the long term. Stapedectomies were performed on 47 children. Preoperative hearing results were compared with 6-month postoperative hearing results. Hearing results for the children who had long-term follow-up (5 years or more) were compared with the 6-month postoperative results. Stapedectomy was successful (postoperative air conduction pure-tone average [PTA] within 10 dB of the preoperative bone conduction PTA) in 91.7% of the cases. The mean overclosure of the preoperative bone conduction PTA by the postoperative air conduction PTA was 0.2 dB. The mean PTA hearing improvement was 32.8 dB. Results from the 21 children (28 ears) who had long-term follow-up indicated an average 0.7 dB/year PTA worsening from the 6-month postoperative PTA. Results from this study provide additional evidence that stapedectomy can be an effective procedure for correcting conductive hearing losses due to juvenile otosclerosis.
Adolescent↗
Long-term fate of Plastipore in the middle ear.
Four Plastipore prostheses, removed at revision surgery 7-10 years after implantation, have been examined. The gross appearance of the prostheses was preserved. The prostheses were surrounded by a fibrous tissue capsule and showed fibrous tissue ingrowth localized in peripheral zones. Foreign-body giant cells and macrophages were detected in small numbers. Histologic evidence of breakdown of the prostheses, in the form of microdisintegration of the walls of micropores, was detected on a small scale. Compared to the massive foreign-body reactions reported in short-term studies, the tissue reaction apparently subsides with time and becomes insignificant. Strict criteria for insertion should be regarded.
Adult↗
Ossicular reconstruction with titanium prosthesis.
OBJECTIVES: To evaluate the results when using titanium total ossicular replacement prosthesis (TORP) or partial ossicular replacement prosthesis (PORP) in chronic ear disease. STUDY DESIGN: Retrospective chart review was performed. METHODS: Sixty-eight ossicular procedures using a titanium TORP (n = 30) or PORP (n = 38) were performed at a tertiary referral center between December 1999 and June 2002. The ossiculoplasty was performed either alone or in combination with other chronic ear surgery. Cartilage grafts were used universally. Nineteen percent were primary operations, and 6% were planned second stages. The majority were revision procedures. Follow-up ranged from 3 months to 2.5 years. RESULTS: The prosthesis is easy to insert, well tolerated, and has a low extrusion rate. Average air-bone gap (ABG) improvement was 13 dB with closure of the ABG to within 20 dB in 57% of cases. Hearing results were better for primary versus revision cases for PORPs versus TORPs and for intact canal wall (ICW) procedures versus canal wall-down (CWD) procedures. CONCLUSION: Titanium is a satisfactory material for use in ossicular reconstruction because of its ease of insertion, tissue tolerance, and low rate of extrusion. Caution is advised when selecting candidates for this procedure during revision surgery, especially if the canal wall and stapes superstructure are absent.
Adult↗