Article
Orbital reconstruction with Biosprites hydroxyapatite implant made in Vietnam and Bioceramic made in France: a comparative randomized study of 62 cases
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Published: | September 18, 2006 |
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Outline
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Objective
To evaluate the result of treatment and the tolerance (biocompatibity) of the Biosporites materials between the home-made products and the imported ones.
Methods
The prospective clinical study in 62 cases distributing randomly to 2 groups: 31 cases with Biosprites implant and 31 cases with Bioceramic implant. The outcomes between 2 groups were evaluated by variables as diplopia, restriction of ocular motility, enophthalmos, hypoglobus. Meanwhile, the tolerance of the porous alloplastic materials were investigated by variables as postoperative inflammation and duration of resolved inflammation. Mean postoperative follow-up was 3.2 months.
Results
There was no statistical significant difference in the outcome and the tolerance of porous alloplastic materials between the 2 groups (p>0.05) .Despite the fact that in the group 1 using Biosporites implant, a case of aseptic abscess showed good result after being replaced by the Bioceramic implant. Besides, the 2 cases in the group 1 underwent partial removal of Biosporites implant migrating forward. No severe postoperative complication was noticed.
Conclusions
The Biosporites materials, made from the coral of the sea in Vietnam, have the same good result and the same biocompatibility as the Bioceramic materials. With the great difference of price (12USD/300USD), the Biosporites can be used widely for the low-income patients in Vietnam. Besides implant materials, many factors involve on the outcome of orbital reconstruction such as operative technique, duration from injury to surgery, severity of orbital deformation.