A modified prosthesis head for middle ear titanium implants--experimental and first clinical results. 2010

Jan Christoffer Luers, and Karl-Bernd Huttenbrink, and Axel Mickenhagen, and Dirk Beutner
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Cologne, Cologne, Germany.

OBJECTIVE An ossicular chain defect represents a challenging situation for otosurgeons. Despite modern reconstruction techniques, unsatisfying postoperative hearing results regularly occur. These are commonly caused by prosthesis dislocation. Whereas the reasons for prosthesis dysfunction occurring months or years after implantation are related to independent chronic conditions, early events of dislocations are more related to the technical fixation of the prosthesis inside the middle ear cavity. Consequently, a safe coupling between prosthesis head and tympanic membrane is essential for a successful type III tympanoplasty. Our study evaluated the use of a new prosthesis design with the aim to reduce short-term postoperative prosthesis dislocation in mind. METHODS Prospective experimental and clinical study. METHODS A modified titanium total ossicular replacement prosthesis (TORP), whose head had spikes that extend into the cartilaginous neotympanic membrane, was designed and tested experimentally and then clinically. The lateral holding force of the new prosthesis head against lateral shift was measured and compared with common prosthesis heads without spikes. After proving this design experimentally, the prostheses were used intraoperatively in 35 tympanoplasty type III operations. Results were analyzed prospectively and compared with 35 retrospectively analyzed controls with conventional TORP prostheses. RESULTS The lateral holding forces for the spike prosthesis heads were significantly higher (134 mN) than those for common prosthesis heads (92 mN) at a contact pressure of 100 mN. Postoperatively, pure-tone audiometry revealed satisfying hearing results. Spiked and conventional titanium TORPs yielded postoperative air-bone gaps (ABGs) of 20.9 and 18.6 dB with 54% and 57% ABG closure, within 20 dB, respectively. The air-bone gap was reduced by an average of 14 and 15 dB, respectively. However, these differences were not statistically significant. Both in the study and in the control group, no signs of prosthesis dislocation were discovered. CONCLUSIONS The experimental data show that the new modified prosthesis head has an increased lateral holding force and thus reduces the risk of dislocation at the coupling side of the tympanic membrane. The postoperative hearing results are comparable to those of conventional prostheses. To confirm the advantage of the modified prosthesis plates over conventional prostheses, future studies with larger study populations are necessary.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009998 Ossicular Prosthesis An implant used to replace one or more of the ear ossicles. They are usually made of plastic, Gelfoam, ceramic, or stainless steel. Implant, Middle Ear,Middle Ear Implant,Ossicular Replacement Prosthesis,PORP,TORP,Implant, Ossicular Replacement,Ossicular Replacement Implant,Ossicular Replacement Prostheses,Prostheses, Ossicular Replacement,Prosthesis, Ossicular Replacement,Replacement Implant, Ossicular,Replacement Prostheses, Ossicular,Replacement Prosthesis, Ossicular,Ear Implant, Middle,Ear Implants, Middle,Implants, Middle Ear,Implants, Ossicular Replacement,Middle Ear Implants,Ossicular Prostheses,Ossicular Replacement Implants,Ossicular Replacement Prosthese,Prostheses, Ossicular,Prosthesis, Ossicular,Replacement Implants, Ossicular
D010033 Otitis Media Inflammation of the MIDDLE EAR including the AUDITORY OSSICLES and the EUSTACHIAN TUBE. Middle Ear Inflammation,Inflammation, Middle Ear
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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