An 8-year follow-up of Ceravital middle ear prostheses showed there was extremely good tolerance in the middle ear space. Incompatibility phenomena were not observed, and inflammatory reactions were neither caused nor supported by the implants. The tympanoplasties were always performed without interposition of cartilage between the tympanic membrane or the tympanic membrane graft and the disk-shaped portion of the implant, and extrusions were never observed. Long-lasting inflammatory processes appeared to destroy implants the same way they destroy ossicles. Transient inflammatory periods (such as episodes of purulent otitis media, which occurred soon after the prostheses were implanted) did not lead to any remarkable changes of the surface of the implant. In healthy middle ears, the hearing results were stable.
The bioactive glass ceramic "Ceravital" was used to fashion prostheses for the replacement of various ossicles in the middle ear. They were tested in 70 rabbit ears, where they were accepted in osseous areas without formation of surrounding fibrous tissue. Histological examinations regularly showed an osseous bond with the surrounding bony tissue. Mucous membrane covered these ossicular chain prostheses and showed no evidence of inflammatory reactions. Glass ceramic implants were also used to reconstruct the ossicular chain and the posterior wall of the outer ear canal in 100 patients. The functional results were satisfactory in all cases.
In the search for better materials for middle ear reconstruction, ceramics have been suggested as an alternative. The bioactive glass‐ceramic Ceravital8 was made available to us for animal experiments and clinical trials.
To test its suitability in ear surgery, 101 ear operations were carried out in 53 rabbits including the reconstruction of 78 posterior auditory canal walls and the insertion of 174 middle ear implants. Parameters studied include the effects of bone paté in inducing new bone growth, the chronological course of bone apposition and remodeling, microscopic examination of mucous membrane growth on the implants and degree of lysis of the implant.
In the past two and one half years some 250 ossicular prostheses have been implanted in man for reconstruction of the ossicular chain. A statistical analysis of 119 tympanoplasties after a follow‐up of one and one half years shows no perforations of the tympanic membrane over the implants or rejection of the prosthesis from the middle ear. The audiological results achieved were more favorable with the use of ossicular prostheses made of bioactive glass‐ceramic than those using allogenic ossicular grafts.
On the basis of the histologic findings and observed clinical results, the bioactive material Ceravital® is remarkably well suited for reconstruction of the posterior auditory canal wall and for implantation in direct contact with the tympanic membrane.
Not only the high risk of necrobiotic alterations in the acetabulum fragment, but more important the osteoarthritic signs and pains very few years after tripleosteotomy are cogent arguments against this measure. The bad results of tripleosteotomy are well explained by simple biomechanic causes.
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