Uji Biokompabilitas pada Implan Orthopedi Antara Implan Impor, Implan Lokal dari Material Impor, dan Prototipe Stainless Steel 316L dari Material Lokal

Ferdiansyah Mahyudin, Heppy Chandra Waskita, Dwikora Novembri Utomo, Heri Suroto, Tri Wahyu Martanto

Abstract

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.

Keywords                   : stainless steel 316L, biocompatibility, orthopaedic implant

Correspondence to    : ferdiansyah@fk.unair.ac.id

 

ABSTRAK

Kebutuhan implan orthopedi terus meningkat di Indonesia, namun produksinya terbatas dan sebagian besar masih impor dari luar negeri. Stainless steel, utama 316L adalah salah satu metal yang sering digunakan. Penelitian ini mengevaluasi biokompatibilitas dari prototipe implan stainless steel 316L, implan lokal yang diproduksi menggunakan stainless steel impor, dan implan stainless steel impor. Uji sitotoksisitas menggunakan sel mesenkim human dengan MTT assay. Uji iritasi, uji pirogenositas, dan uji implantasi menggunakan 24 tikus Wistar yang terbagi dalam 4 grup. Kami mengevaluasi skor Draize, perubahan berat dan temperatur rektal, dan ketebalan fibrous capsule ring. Uji sitotoksisitas menunjukkan persentase viabilitas sel pada prototipe stainless steel 316L, implan lokal, dan implan impor berturut-turut adalah 83,7%; 87,5%; dan 83,7%. Uji komparasi dengan One Way Anova tidak menunjukkan perbedaan signifikan diantara 3 grup (p>0,05). Hasil uji iritasi 3 grup menunjukkan grade 0 (tidak ada edema dan eritema). Uji pirogenositas tidak menunjukkan perbedaan signifikan pada semua grup (p>0,05). Tidak ada perbedaan signifikan (p>0,05) pula pada ketebalan fibrous capsule ring di minggu ke 1 dan 4 setelah implantasi. Berdasarkan ISO untuk pedoman uji di bidang medis, prototipe stainless steel 316L aman dan memiliki kesamaan hasil uji biokompatibilitas bila dibandingkan dengan implan lokal dan impor.

Kata kunci              : stainless steel 316L, uji biokompatibilitas, implan orthopaedi

Korespondensi       : ferdiansyah@fk.unair.ac.id

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DOI: http://dx.doi.org/10.30651/jqm.v3i1.1612