Ferdiansyah Mahyudin and Heppy Chandra Waskita and Dwikora Novembri Utomo and Heri Suroto and Tri Wahyu Martanto (2019) Uji Biokompabilitas pada Implan Orthopedi Antara Implan Impor, Implan Lokal dari Material Impor, dan Prototipe Stainless Steel 316L dari Material Lokal. Qanun Medika, 3 (1). pp. 7-13. ISSN 2548-9526

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Abstract

Demands of orthopedic implants are increasing in Indonesia, but its production are limited and still imported. Stainless steel, especially 316L is one of metal that is used commonly. This research evaluates biocompatibility of stainless steel 316L implant prototype, local implant manufactured using imported stainless steel, and imported stainless steel implant. Cytotoxicity test used mesenchymal human cell with MTT assay. Irritation test, acute toxicity/pyrogenicity test, and implantation test used 24 Wistar rats respectively which were assigned to 4 groups. We evaluate Draize score, weight and rectal temperature changes, and fibrous capsule ring thickness. Cytotoxicity test shows viable cell percentage in stainless steel 316L implant prototype, local implant, and imported implant are 83.7%, 87.5%, and 83.7% respectively. Comparison test using One Way ANOVA shows no significant difference between 3 groups (p>0.05). Iritation test results in 3 groups are grade 0 (no edema and no erythema). Acute toxicity/pyrogenicity test shows no statistically significant difference (p>0.05) among all groups. There is also no significant difference (p>0.05) of fibrous capsule ring thickness on 1 and 4 weeks after implantation. Based on ISO for medical test guide, stainless steel 316L implant prototype is safe and has similar biocompatibility test result compared to local and imported implant.

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