Institute of Medical and Biological Engineering, University of Leeds, UK.
Spine (Phila Pa 1976). 2012 Apr 20;37(9):E528-34. doi: 10.1097/BRS.0b013e31823cbd6e.
An in vitro study of the wear rates of the CHARITÉ lumbar total disc replacement (TDR).
To investigate the effect of anterior-posterior shear on the in vitro wear rates of the CHARITÉ lumbar TDR.
Current standards prescribe only 4-degrees of freedom (DOF) inputs for evaluating the in vitro wear of TDRs, despite the functional spinal unit incorporating 6 DOF. Anterior-posterior shear has been highlighted as a significant load, particularly in the lumbar spine. A previous study investigated the effect of an anterior-posterior shear on the ProDisc-L, finding that wear rates were not significantly different from 4-DOF wear tests.
Six CHARITÉ lumbar discs were mounted in a 5 active DOF spine wear simulator and tested under 4-DOF (ISO18192) conditions. Six further CHARITÉ lumbar discs were tested under 5-DOF conditions, consisting of 4-DOF conditions plus an anterior-posterior shear displacement of +2/-1.5 mm. The displacement was decreased and then increased by a factor of 2 to investigate the effect of the magnitude of displacement. Micro-computed tomographic scans of the discs were taken before and after wear testing, and the height loss of the discs was calculated. These were compared with the same measurements taken from explanted CHARITÉ discs, micro-computed tomography scanned at another institution.
Wear rates for 4 DOF (12.2 ± 1.0 mg/MC) were not significantly different from 4-DOF tests on the ProDisc-L. Wear rates were significantly increased (P < 0.01) for "standard" 5-DOF conditions (22.3 ± 2.0 mg/MC), decreased 5 DOF (24.3 ± 4.9 mg/MC), and increased 5 DOF (29.1 ± 7.6 mg/MC). The height loss of the explants and in vitro tested discs were not significantly different (P > 0.05).
The addition of anterior-posterior shear to wear testing inputs of the CHARITÉ lumbar TDR increases the wear rate significantly, which is in direct contrast to the previous 5-DOF testing on the ProDisc. This study highlights the importance of clinically relevant testing regimens, and that test inputs may be different for dissimilar design philosophies.
CHARITÉ 腰椎整体置换椎间盘的磨损率的体外研究。
研究前-后剪切对 CHARITÉ 腰椎 TDR 体外磨损率的影响。
目前的标准仅规定了用于评估 TDR 体外磨损的 4 个自由度(DOF)输入,尽管功能脊柱单元包含 6 个 DOF。前-后剪切已被强调为一种重要的载荷,特别是在腰椎。先前的一项研究调查了前-后剪切对 ProDisc-L 的影响,发现磨损率与 4-DOF 磨损试验没有显著差异。
将 6 个 CHARITÉ 腰椎椎间盘安装在 5 个主动 DOF 脊柱磨损模拟器中,并在 4-DOF(ISO18192)条件下进行测试。另外 6 个 CHARITÉ 腰椎椎间盘在 5-DOF 条件下进行测试,由 4-DOF 条件加前-后剪切位移+2/-1.5mm 组成。通过将位移减小然后增加 2 倍来研究位移幅度的影响。在磨损试验前后对椎间盘进行微计算机断层扫描,并计算椎间盘的高度损失。将这些与从 CHARITÉ 椎间盘取出的相同测量值进行比较,并在另一机构进行微计算机断层扫描。
4-DOF(12.2±1.0mg/MC)的磨损率与 ProDisc-L 的 4-DOF 测试没有显著差异。“标准”5-DOF 条件(22.3±2.0mg/MC)的磨损率显著增加(P<0.01),降低 5-DOF(24.3±4.9mg/MC)和增加 5-DOF(29.1±7.6mg/MC)。离体测试椎间盘和植入物的高度损失没有显著差异(P>0.05)。
在前-后剪切力的作用下,CHARITÉ 腰椎 TDR 的磨损率显著增加,这与之前对 ProDisc 的 5-DOF 测试结果直接相反。本研究强调了临床相关测试方案的重要性,并且对于不同设计理念的测试输入可能不同。