Medical Devices: Evidence and Research (Sep 2020)
The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety
Abstract
Annette Kienle,1 Nicolas Graf,1 Carina Krais,1 Hans-Joachim Wilke2 1SpineServ GmbH & Co. KG, Ulm 89077, Germany; 2Institute of Orthopaedic Research and Biomechanics, Ulm University Medical Centre, Ulm 89081, GermanyCorrespondence: Annette KienleSpineServ GmbH & Co. KG, Soeflinger Strasse 100, Ulm 89077, GermanyTel +49 731 3885 1946Fax +49 731 1590 975Email [email protected]: There are various cervical disc prostheses on the market today. They can be subdivided into implants with a ball-and-socket design and implants with a flexible core, which is captured between the implant endplates and sealed using various sheaths. Implants with an articulating surface are mostly metal-on-metal or metal-on-UHMWPE designs and, thus, do not allow for axial damping. The aim of this study is to provide mechanical safety and performance data of the MOVE-C cervical disc prosthesis which combines both an articulating surface and a flexible core.Materials and Methods: MOVE-C consists of a cranial and caudal metal plate made of TiAl6V4. The cranial plate is TiNbN coated on its articulating surface. The caudal plate has a fixed polycarbonate-urethane (PCU) core. The TiNbN coating is meant to optimize the wear behavior of the titanium endplate, whereas the PCU core is meant to allow for a reversible axial deformation, a pre-defined neutral zone and a progressive load-deformation curve in all planes.Results: Various standard testing procedures (for example, ISO 18192– 1 and ASTM F2364) and non-standard mechanical tests were carried out to prove the implant’s mechanical safety. Due to the new implant design, wear and creep testing was deemed most important. The wear rate for the PCU was in maximum 1.54 mg per million cycles. This value was within the range of the UHMWPE wear rates reported for other cervical disc prostheses (0.53 to 2.59 mg/million cycles). Also in the creep-relaxation test, a qualitatively physiological behavior was shown with a certain amount of remaining deformation but no failure.Conclusion: The mechanical safety of the MOVE-C cervical disc prosthesis was shown to be comparable to other cervical disc prostheses. Since PCU wear particles were elsewhere shown to be less bioactive than cross-linked UHMWPE particles, wear-related failure in vivo may be less frequent compared to other prostheses. This, however, will have to be shown in further studies.Keywords: disc arthroplasty, degenerative disc disease, cervical spine, polycarbonate-urethane, creep, wear
