Review

Functional Testing and Evaluation Tactics of Artificial Cervical Disc Prosthesis In Vitro

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  • Center for Medical Device Evaluation,China Food and Drug Administration

Received date: 2017-12-20

  Revised date: 2018-02-08

  Online published: 2020-07-23

Abstract

Artificial cervical disc replacement which retains the movement of adjacent vertebral segments, reduce the stress level of adjacent segments, is conducive to preventing the degeneration of adjacent segments. At present, the domestic application of artificial cervical disc prosthesis is mainly imported products, most of domestic similar products are in the process of R&D and production. The in vitro evaluation methods of prosthetic cervical intervertebral disc prosthesis in vitro was presented, including subsidence, creep, expulsion, subluxation testing, dynamic and static compression, shear testing, wear testing. Combined with the biomechanical data of human cervical spine, the clinical safety and effectiveness of the product was evaluated. Based on the open data of the FDA on artificial cervical disc prosthesis, the results of in vitro functional tests of 5 different designs of artificial cervical disc prosthesis were analyzed and compared. The acceptable criterion for the in vitro evaluation test of artificial disc prosthesis was discussed,which can provide a reference for the R&D of domestic products.

Cite this article

ZHANG Jiazhen,ZHAI Bao,MIN Yue,LIU Bin . Functional Testing and Evaluation Tactics of Artificial Cervical Disc Prosthesis In Vitro[J]. Journal of Tissue Engineering and Reconstructive Surgery, 2018 , 14(2) : 61 -66 . DOI: 10.3969/j.issn.1673-0364.a471

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