Following our previous experimental studies on the performance of macroporous biphasic calcium phosphate (MBCP) in canine mastoid cavities, we used this material in patients requiring surgical intervention. Twenty-two cases were selected, and in eight specific cases a biopsy specimen was taken. Histologic, ultrastructural, and microanalysis studies were performed. This study demonstrates the effectiveness of MBCP implants as bone graft substitutes for mastoid cavity obliteration. Clinical evaluation of the series and histologic and ultrastructural results demonstrated the bioactivity and osteo-conduction of this material, with partial transformation of MBCP granules into lamellar bone after several months.
Bone reconstruction is still a matter of concern in middle ear surgery despite the large number of surgical techniques proposed. Combination of biphasic calcium phosphate bioceramics with human fibrin sealant forms a moldable material easy to apply for bone reconstruction. Since 1986, we have been using this composite for reconstruction of mastoid cavities during chronic otitis media surgery. Granules of ceramic provide immediate mechanical stability and later on, promote osseoinduction when fibrin sealant forms a strong bond between granules enhancing the wound healing process. After checking feasibility, efficacy and tolerance through a controlled study on dogs by filling mastoid cavities, we started a clinical series comprising yet 66 mastoid reconstructions. A retrospective data analysis on 63 patients with an average follow up of 42 months including 12 histological controls confirms the stability of bone reconstruction with a remarkable tolerance of the skin in contact. Biopsies confirmed progressive replacement of material by lamellar newly formed bone. Mastoid cavities have a randomed shape making complex bone reconstruction procedure and their filling by the composite constitutes an easy way and represents a highly satisfactory procedure. The authors considered that this should be explored in other indications of bone surgery.
The biocompatibility of vitreous carbon and carbon fibre reinforced carbon (CFRC) as middle ear implants was investigated. In separate animal model systems, vitreous carbon was implanted in the middle ear of 20 DA rats for up to 6 months, whilst 3 varieties of CFRC (basic or crude, ultrasonically cleaned, glazed) were implanted in 98 guinea-pig middle ears for up to 4 months. Tissue reactions to implantation were assessed by means of stereoscopic and standard light microscopy, and scanning electron microscopy with chemical analysis facilities (EDAX, WDAX). Vitreous carbon and glazed CFRC were considered suitable for human implantation and a trial of the latter was started in 23 patients (14 partial, 9 total ossicular implants). At 9 months, only 52% of the implants were still in situ; 40% had been extruded and 8% had elicited inflammatory responses which would undoubtedly result in extrusion. Carbon particle dissemination with carbon fibre destruction and exposure as a result of peroperative prosthesis drilling were considered the likely causes for the failure of this implant.
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