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PubMed1987

Soft tissue reaction to ceramic ossicular replacement prosthesis.

Soft-tissue reaction to ceramic ossicular replacement prostheses (CORP) has been evaluated histologically in rabbits and humans. One week after implantation, severe inflammatory and foreign body reaction was observed in the fibrous connective tissue surrounding the prosthesis. Though some inflammatory response was seen after one month, after three months the CORP was surrounded by a layer of fibrous connective tissue without any foreign body giant cell, histiocyte or inflammatory cell infiltration. Our satisfactory clinical results in humans without placing a cartilage between the CORP and the fascia graft may be due to the excellent soft-tissue compatibility of CORP, as demonstrated in this study.

Aluminum↗
PubMed2004

Influence of the shape and material on the behaviour of a total ossicular replacement prosthesis.

OBJECTIVE: To study the influence of the shape and the material on the behaviour of a total ossicular replacement prosthesis (TORP). MATERIAL AND METHODS: It was hypothesized that the influence of the shape and material of a TORP on its performance could be quantified using a simple mechanical model. The prosthesis is represented simply by an axisymmetric shape and two models are used. In the first model, we assume that the strain of the prosthesis is negligible, whereas the strain is taken into account in the second model. In both cases, literature plots of stapes displacement versus frequency are used to check the validity of the modelling. RESULTS: It was found that the influence of the strain of the implant was insignificant in comparison to its rigid body movement. Furthermore, if it is assumed that the reaction force exerted by the inner ear on the stapedial footplate depends on both frequency and mass, it can be shown that the human body is able to adapt itself to the mass and shape of the prosthesis. CONCLUSION: As the prosthesis is not strained and no material criteria appear in the equation used in the modelling, both materials studied, titanium and hydroxyapatite, are equivalent from a mechanical point of view. In addition, a cylindrical prosthesis would give good results in response to an external stimulus but its very rigidity could damage the inner ear during pressure shocks.

Biocompatible Materials↗
PubMed1982

Polyethylene sponge total ossicular replacement prosthesis. A histopathologic study.

The histopathologic findings of a functioning high-density polyethylene sponge (Plastipore) total ossicular replacement prosthesis in a patient who died of unrelated causes are reported herein. The lack of inflammatory cell infiltration of foreign-body giant cells within, or adjacent to, the prosthesis helps substantiate the safety and efficacy of Plastipore in the reconstruction of the ossicular chain.

Adult↗
PubMed2005

Malleus-to-footplate ossicular reconstruction prosthesis positioning: cochleovestibular pressure optimization.

AIMS: To determine 1) the best position for hydroxylapatite malleus-to-footplate (MFP), ossicular replacement prosthesis (ORP) in reconstructed ears, and 2) whether preserving the stapes superstructure (SS), when present, has acoustic advantages. BACKGROUND: Positioning of the MFP-ORP head beneath the neck of the malleus may produce maximal force, whereas positioning beneath the manubrium of the malleus may produce the greatest displacement. It is not clear which is the optimal placement position. In addition, we look at the effect of the SS on sound transmission to the inner ear in ossicular reconstruction. METHODS: The ear-canal air pressure and vestibular hydro-pressure were measured in human cadaver temporal bones with incus intact, removed, and replaced with the MFP-ORP; the ORP head was placed at three different positions on the malleus (head, mid-manubrium, and umbo) while keeping its base at the center of stapes footplate with intact or removed stapes SS. The vestibular pressure ratio between the ear with intact incus and MFP-ORP reconstructed ear is defined as Lmfp, the loss caused by the prosthesis in relation to the normal ossicular chain. RESULTS: The mean magnitude of Lmfp, averaged in the important speech frequency region of 0.5 to 3 kHz, is approximately 7.8 dB at the neck with stapes SS. In comparison, mean magnitude of Lmfp for mid-manubrium without stapes SS is 15 dB (p = 0.04), and with the stapes SS it is 16 dB (p = 0.05), whereas at the umbo without SS it is 15 dB (p = 0.03). In the 8 kHz region, the mean magnitude of Lmfp is approximately 1 dB with the stapes SS intact and approximately 8.5 dB when it was removed (p < 0.09). CONCLUSION: There are significant physiologic advantages to placing the hydroxylapatite MFP-ORP beneath the neck of the malleus and preserving the SS.

Aged↗
PubMed1978

Use of tragal cartilage with the total ossicular replacement prosthesis.

A method was developed for the use of tragal cartilage and perichondrium with the total ossicular replacement prosthesis. The method involves securing the flat base of the prosthesis in a perichondrial tunnel on the cartilage to stabilize the prosthesis, prevent extrusion, and promote vascularization.

Cartilage↗
PubMedDate not supplied

Aluminum oxide ceramic ossicular replacement prosthesis.

Two different prototypes of columella materials made from aluminum oxide ceramics were newly designed by the author for ossicular reconstruction. CORP-P (ceramic ossicular replacement prosthesis-partial) is used as a columella to fit onto the stapes head, and CORP-T (ceramic ossicular replacement prosthesis-total) is used as a columella placed onto the footplate of the stapes. In addition to the general properties of ceramic implants, CORP has these two characteristics: the unique shape of its head, which allows easy and smooth contact with the fascia graft, and the radiopacity, which makes it possible to confirm the position of the implants by x-ray examination after implantation.

Aluminum Oxide↗
PubMed2004

Optimum tension for partial ossicular replacement prosthesis reconstruction in the human middle ear.

OBJECTIVE: Hearing results from ossiculoplasty are unpredictable. There are many potentially modifiable parameters. One parameter that has not been adequately investigated in the past is the effect of tension on the mechanical functioning of the prosthesis. Our goal was to investigate this parameter further, with the hypothesis that the mechanical functioning of partial ossicular replacement prostheses (PORP) from the stapes head to the eardrum will be affected by the tension that they are placed under. METHODS: Fresh temporal bones were used to reconstruct a missing incus defect with a PORP-type prosthesis. Three different lengths of PORP were used, and the stapes vibrations were measured with a laser Doppler vibrometer using a calibrated standard sound in the ear canal. Eight temporal bones were used. RESULTS: Tension had a very significant effect on stapes vibration. In general, loose prostheses resulted in the best overall vibration transmission. The effects were most marked at the lower frequencies. There was a slight advantage to tight prostheses in the higher frequencies, but much less than the decrement in lower frequencies with tight prostheses. CONCLUSION: In ossicular reconstruction, best stapes vibration results in our model are achieved by shorter prostheses, which result in lower tension.

Cadaver↗
PubMed1988

Long-term histologic study of a new carbon-carbon ossicular replacement prosthesis.

In a variety of structural forms, carbon possesses certain properties that render it suitable for implantation in the human body. This report analyzes biocompatibility of a new carbon-carbon prosthesis following long-term middle ear implantation in a prospective, controlled animal study. The prosthesis was placed in the left ear of 20 healthy guinea pigs and in the dorsal subcutaneous tissues for control. The right ear also served as control. Preoperative and postoperative auditory evoked potentials were recorded and compared. Samples of tissue from all three sites were evaluated at 3 and 6 months by light microscopy. The implants also were evaluated by scanning electron microscopy. Samples of lymph nodes, liver, spleen, and lungs also were examined. Fourteen animals (70%) demonstrated no change in auditory evoked potentials postoperatively. One animal developed unilateral dysfunction and three others developed bilateral dysfunction for unexplained reasons. No significant tissue destruction or inflammation of the tissues and no digestion or erosion of the implants were observed. No passage of carbon particles into the reticuloendothelial system was identified. These preliminary results suggest that this new carbon-carbon prosthesis may be biocompatible at 6 months follow-up in the guinea pig and encourage further investigation.

Animals↗
PubMed2007

Prognostic factors in ossiculoplasty.

OBJECTIVE: To analyze predictive factors of outcome after ossiculoplasty using a standard ossicular prosthesis system. STUDY DESIGN: Retrospective review of 140 ossiculoplasties, performed by the same senior surgeon, with titanium prostheses. SETTINGS: Academic hospital and tertiary referral center. PATIENTS: All patients undergoing ossiculoplasty with Spiggle and Theis or Kurz titanium total and partial prostheses. Documented, postoperative follow-up had to be provided. A total of 129 patients (140 ears; 53 men and 76 women) were evaluated. INTERVENTIONS: These included ossiculoplasties using 75 Spiggle and Theis prostheses (30 partial and 45 total) and 65 Kurz prostheses (35 partial and 30 total). MAIN OUTCOME MEASURES: Mean preoperative and postoperative air-bone gaps and the changes in mean hearing loss were analyzed using a four-frequency (500, 1,000, 2,000, and 3,000 Hz) pure tone average. Success rate was defined as postoperative air-bone gap within 20 dB. A one-way analysis of variance was used to analyze group differences. A multivariate statistical analysis was then undertaken to define the significant factors. RESULTS: There were no statistical difference between the Spiggle and Theis and the Kurz prostheses. Multivariate statistical analysis has identified the predictive value of the presence or absence of the malleus handle and the mucosal status of the middle ear in the prognosis of ossiculoplasties. CONCLUSION: Anatomical and technical factors diversely affect the functional outcome of tympano-ossiculoplasties. A better knowledge of their predictive value will enable accurate, preoperative, individual assessment when counseling patients with regard to the success of any proposed intervention. The use of these factors will also permit precise matching of future series to allow accurate comparisons.

Adolescent↗
PubMed1976

Plastipore total ossicular replacement prosthesis.

In those ears in which the incus and/or malleus are missing or not suitable, a columella made of high density polyethylene sponge has proven to be very effective. Tissue readily grows into the large pores of this material so that it is well tolerated in the body. During the last six months 54 have been implanted with no rejection so far and a good hearing gain in 43 or 80 percent.

Biocompatible Materials↗