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NCT07304999
Otosclerosis is a pathological bone remodeling process that affects the middle and inner ears. It was first reported by Antonio Maria Valsalva in 1735 and subsequently described pathologically by Adam Politzer in 1839 . In otosclerosis, the normal, dense endochondral bone of the otic capsule around the inner ear labyrinth is replaced by irregularly laid spongy bone, which subsequently hardens and leads to fixation of the stapes footplate . Otosclerosis causes progressive conductive hearing loss that typically presents with a normal tympanic membrane. However, a reddish shadow on the promontory of the cochlea may be seen in some cases (Schwartze sign) if the tympanic membrane is clear enough. Initial symptoms of otosclerosis include decreased sensitivity to low-frequency sounds, such as whispers. Patients may also paradoxically deny difficulty hearing conversation in loud background noise, which is termed "paracusis Willisii" or "paracusis of Willis,. Tinnitus may worsen as the disease progresses. Vertigo is usually mild, but as the disease progresses, balance may deteriorate, mimicking Ménière disease. . On physical examination, patients with otosclerosis may speak in low volume and monotonous voices. Otoscopy may reveal no abnormalities at all. With active otosclerosis, however, increased vascularity of the cochlear promontory may be visible through the tympanic membrane A Weber test performed with a 512 Hz (Hertz) fork will generally lateralize toward the ear with the conductive loss or toward the ear with the greater conductive loss in cases of bilateral otosclerosis . In most cases of otosclerosis, pure tone audiometry shows low frequency decreases in air conduction thresholds. Bone conduction, however, typically remains normal. A "Carhart notch" is often seen, which is an artifactual dip in the bone conduction line by 20-30 dB(disciple) at 2,000 Hz due to the resonance frequency of the ossicular chain . There is no medical therapy that is curative for otosclerosis. Though sodium fluoride is prescribed to slow the progression of otosclerosis, its efficacy is still controversial and In stapes surgery different surgical techniques, approaches and prostheses in order to restore sound transmission have been described. Stapedectomy was first described by Shea.Jr in 1956. Surgical techniques for treatment of otosclerosis have been improved, updated, or adjusted over time to lower intraoperative and post-operative problems and boost overall effectiveness . The treatment of choice is stapedotomy or stapedectomy, along with the placement of a prosthesis. In these procedures, either a hole is drilled in the center of the stapes footplate with a high-speed microdrill or a laser (stapedotomy), and a prosthesis is placed between the long process of the incus and the oval window membrane via the hole in the stapes footplate, or the stapes footplate is removed partially or in its entirety and a prosthesis placed between the incus and the oval window, typically with a vein or fascia graft used to protect the oval window membrane (stapedectomy). In both procedures, the crura of the stapes are fractured, and the incudo stapedial joint is divided in order to permit the removal of the stapes superstructure. Surgical treatment for otosclerosis generally produces good outcomes, irrespective of the approach employed, provided appropriate patient selection. For patients with bilateral otosclerosis, the ear with greater hearing loss is typically addressed first; both ears are not operated under the same anesthetic in order to avoid the very unlikely scenario in which total sensorineural hearing loss occurs bilaterally as a result of surgery. A 2018 review published by Cheng et al indicated comparable results between stapedotomy and stapedectomy, with a slight advantage in terms of high- frequency hearing and complication rate for stapedotomy . Microscopic trans canal or end aural approach is the most preferred technique in stapes surgery . Although microscopes provide good magnification and let both hands use, sufficient exposure of stapedial structures might not be possible under microscopic approach without bone curettage . In microscopic approaches, extensive curettage of scutum may result in complications such as chorda tympani nerve injury, impaired taste sensation, subluxation of ossicles, retraction pockets and postoperative higher pain levels .
NCT02456272
This is a French pilot study in the Toulouse University Hospital that will include a minimum of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.
NCT05921578
Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy.
NCT06618053
Otosclerosis is a localized disorder of the otic capsule, characterized by bone resorption anterior to the oval window in the region of the fissula ante fenestram. This process leads to new sclerotic bone formation, resulting in stapes footplate fixation. It is one of the most common causes of progressive conductive hearing loss in young adults between the age of 30 and 50 year-old. As the disease advances, hearing loss can become mixed and even purely sensorineural due to the pathological process extending into the cochlea. Stapes surgery is the gold standard procedure for restoring mechanical sound transmission through the middle ear. For patients who are not candidates for surgery, hearing aids offer a valid alternative. Over the years, stapes surgery has evolved into a minimally invasive procedure that can be safely performed as day surgery, under either local or general anesthesia. The COVID-19 crisis has exacerbated a shortage in anesthesiology teams, limiting operating room availability. To address this issue, stapes surgery for otosclerosis under local anesthesia were increasingly performed. Local anesthesia has several advantages: it allows for immediate hearing tests after prosthesis placement, enabling early detection and correction of vertigo caused by prosthesis displacement, thus minimizing major complications. Additionally, local anesthesia reduces exposure to general anesthesia, thereby decreasing postoperative morbidities. While there are few studies comparing outcomes and complications of stapes surgery based on the type of anesthesia, a systematic review in 2013 found no difference in postoperative air-bone gap (ABG), sensorineural hearing loss (SNHL), or postoperative vertigo between procedures performed under local versus general anesthesia. No studies have evaluated or compared the cost-effectiveness of stapes surgery for otosclerosis performed under local versus general anesthesia. This study hypotheses that patients undergoing stapes surgery under local anesthesia will have equivalent outcomes to those under general anesthesia, with the potential for reduced costs and operative time.
NCT02019888
The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management. Current physiologic tests of auditory function in the standard clinical audiological test battery for Veterans have limited sensitivity in detecting some middle-ear disorders, and do not include a direct test of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of absorbance for improved sensitivity in the assessment of middle-ear function including acoustic reflex testing. The addition of WB tests of cochlear function included in the WB test battery provides an opportunity to improve audiological diagnosis of a range of hearing disorders in Veterans. The automation provided by the WB test battery could provide additional benefits in reducing the duration of the evaluation, leaving more time for evaluation of test findings and counseling. Results from this study may lead to the improvement of audiological care for Veterans with hearing loss.
NCT03587792
Patients with unilateral transmission hypoacusis due to otosclerosis undergoing stapedectomy surgery will be prospectively included. They will be undergoing a free field vocal audiometry using the Oldenburg MATRIX software to evaluated the squelch effect gain between audiometry before and after 9months after surgery. Our hypothesis is to show a squelch effect with the rehabilitation of the binaural audition.
NCT01855425
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
NCT02554422
Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).