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One Year Experience at the Restoration
of the Auditory Chain with Prosthesis of Ceromer

*M. Milkov, *P. Nedev, †I. Zenev, †K. Kunev, *†P. Rouev, *D. Marev

*Department of Neurosurgery, Ophthalmology and Otorhinolaryngology, University of Medicine “P. Stoianov”, Varna, Bulgaria
†Department of Otorhinolaryngology, University of Medicine, Sofia, Bulgaria
*†Clinic of Otorhinolaryngology, University Hospital, Stara Zagora, Bulgaria

ABSTRACT

Objective: The choice of the appropriate biomaterial is related to the study, the analysis and the experiments for a particular implantation place in the organism. The Targis one of the components of the system of Ceromer of the company Ivoclar AG, Lichtenstein. It has been used in dentistry since 1996. After receiving the certificate of the material, we carried out two-year tests for bio-tolerance in the middle ear of a guinea-pig.
Study desing: Prospective study of patients with a restored ossicular chain by Ceromer prosthesis.
Material and Methods: There are two kinds of prostheses constructed of Targis: PORP and TORP. We are presently working out and improving new kinds of prostheses. The ossicular prostheses were implanted to patients with chronic otitis media. Patients had different stage of auditory loss, more than 20 dB. The state of their ossicular chains was different.
Results: The postoperative state of the patients was very good. After an audiometric study the improvement of the hearing was between 10-20 dB in 7 patients. In 3 of them between 5-10 dB and by 2 patients below 5 dB. During the first two months after the implantation, the extrusion of the prosthesis was not observed.
Conclusion: The one year results show that the Ceromer prostheses can be used at the ossicular reconstruction.
Key words: Chronic otitis media, Ossicular chain prosthesis, Ceromer.
Pro Otology 1:47—48, 2004

Introduction

For the successful implantation of the ossicular prostheses, it is necessary that they should meet a range of requirements. It is quite difficult to determine the most important of them, but yet with no perfect tolerance, the rest of the qualities of the prostheses will be compromised. Going down in history since 1950, after introducing of tympanoplastics by Wulstein and Zoellner, a great number of biomaterials are used in the reconstruction of the auditory chain (1). We recognize the fact, that the Titan material dominates over all the materials and is widely used by the otosurgeons (2).

Yet we carried out an experiment with Targis prostheses as for biotolerance as well as for their physical properties (3-6).

Our ambition was to create prosthesis of good biotolerance, perfect sound transmission qualities and to easily manipulate with them and easily to incorporate in the middle ear space.

MATERIALS AND METHODS

For a period of one year 12 patients were implanted with Ceromer prostheses (FIG. 1). The pains were due to a chronic suppurate inflammation of the middle ear. All the patients took a pre-operative conservative treatment with antibiotics. They met the requirements for ossicular reconstruction. Patients had different stage of auditory loss, more than 20 dB.


FIG. 1. Picture of Ceromer prosthesis: TORP (left) and PORP (right).

RESULTS

Eigth patients were implanted a total prosthesis (TORP) and four of the partial prosthesis (PORP) (Table 1).

The state of the ossicular chain was determined intraoperatively. At three of the patients the ossicles malleus and incus were missing. At four of the patients, the Incus was affected to different stages. In five ears, the ossicular chain was completely demolished. One of the patients had a bilateral chronic otitis media. At four of them during the operation was ascertained cholesteatoma. All the patients were implanted a cartilage lamella with ot without temporalis factia between the “plate” of the prosthesis and the new tympanum membrane. During the first days after the operation no postoperative complications were observed. During the next months, the state of the patients was very good. All of them proved the increase of the auditory perception with more that 15 dB. During the first two months after the implantation, the extrusion of the prosthesis was not observed. In the first six months we were observed extrusion by one patient with cholesteatoma and small tympanic cavity.


Table 1. Clinical diagnosis, implantation time and kind of prosthesis.

Discussion

The material Ceromer meets all the requirements necessary for the implantation. The form of the prosthesis was chosen with the purpose to improve the fastening to the safe parts of the ossicular chain (7). The module of the elasticity and the friction of the Targis material give us reason to consider the material to be sound-conductor. The improvement of the hearing of the patients confirmed the sound conductivity of Targis.

By the use of the Targis prostheses we pose the question for the alternative in the implantation of ossicular prostheses of Titan. Of course we do not call into doubt the perfect qualities of the Titan prostheses (8). But the good one year results with the Targis prostheses afford to the otosurgeons the opportunity to try in their practice prostheses with other materials (9,10). We should be satisfied with the interest manifested by our colleagues and they could be supplied prostheses for implantation.

CONCLUSION

The rapid development of the biomaterials will afford the possibility to improve the parameters of the prostheses for the ossicular plastics. The choice of the kind of the prosthesis is of course to the surgeon, who to a great extend is based to his practice and the challenge of the new technologies.

REFERENCES

  1. Wullstein H. Theory of practice of tympanoplasty. Laryngoscope 1956;66:1076-93.

  2. Martin AD, Harner SG. Ossicular reconstruction with titanium prosthesis. Laryngoscope 2004;114(1):61-4.

  3. Bance M, Morris D, Van Wijhe R, Narine A. How does the mass of a middle ear PORP prosthesis affect its acoustic function? Canadian Society of Otolaryngology, Calgary 2003.

  4. Morris D, Bance M, Van Wijhe R.The effect of adhesion to the promontory on the acoustic functioning of partial ossicular replacement prosthesis in the cadaveric human ear. Canadian Society of Otolaryngology, Calgary 2003.

  5. Bance M, Morris DP,VanWijheR. Effect of cartilage cover and other materials on prosthesis function in ossiculoplasty. American Academy of Otolaryngology-Head and Neck Surgery, Annual Meeting, Orlando 2003.

  6. Bance M, Morris D, Van Wijhe R, Funnel R. A comparison of ossiculoplasty with stapes to malleus and stapes to eardrum prostheses. American Otology Society, Annual Meeting, Nashville Tennesee, USA 2003.

  7. Dormer KJ, Bryce GE, Hough JD. Selection of biomaterials for middle and inner ear implants. Otolaryngologic Clinics of North America 1995;28(1):17-27.

  8. Berenholz L, Lippy WH. Total ossiculoplasty with footplate removal. Otolaryngol Head Neck Surg 2004;130(1):120-4.

  9. Canalis RF, Lambert PR. Chronic otitis media and cholesteatoma. In: Canalis RF and Lambert PR. (Ed.) The Ear. Comprehensive Otology. Lippincot Williams & Wilkins. Philadelphia, 2000:409-32.

  10. Babu S, Seidman MD. Ossicular reconstruction using bone cement. Otol Neurotol 2004;25(2):98-101.

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