CHARITÉ Versus ProDisc: A Comparative Study of a Minimum 3-Year Follow-up
CHARITÉ Versus ProDisc: A Comparative Study of a Minimum 3-Year Follow-up
复制标题
CHARITÉ 与 ProDisc：至少 3 年随访的比较研究
作者：
C. Shim;Sang;Hoseung Shin;Han;Won;B. Jung;G. Choi;Y. Ahn;Seungcheol Lee;Ho Yeon Lee
研究设计。回顾性研究。目标。评价和比较CHARITÉ和ProDisc的临床和放射学结果。背景资料摘要。没有临床报告比较CHARITÉ和ProDisc。方法。在61例接受全椎间盘置换术的患者中，有57例患者随访超过3年。33例患者使用CHARITÉ， 24例患者使用ProDisc。对52例患者进行了MRI随访。评估临床和放射学数据，包括活动范围（ROM）和替代节段的突面退变，以及相邻节段的椎间盘退变。结果。CHARITÉ组和ProDisc组的Oswestry残疾指数（ODI）评分改善率分别为78.9%和75.8%。视觉模拟量表（VAS）疼痛评分CHARITÉ组平均改善72%，ProDisc组平均改善74.2%。两组患者ODI评分和VAS评分的改善率均无统计学差异。36.4%的CHARITÉ和32%的ProDisc出现了切面退化。在CHARITÉ和ProDisc中分别有19.4%和28.6%的椎间盘退变发生在指数水平以上的相邻水平。两组间关节突关节及相邻节段椎间盘退化率无显著差异。更换后节段的ROM保存良好，但ProDisc的L5-S1的ROM明显少于CHARITÉ。结论。虽然CHARITÉ组和ProDisc组的临床结果都相当好，但无论使用何种器械，在相当数量的患者中，指数水平的小面关节和相邻水平的椎间盘显示退行性过程加重，这引起了对全椎间盘置换术可能的晚期后果的关注，特别是关于小面关节和相邻节段疾病。
Study Design. A retrospective study. Objectives. To evaluate and compare clinical and radiologic outcomes of the CHARITÉ and ProDisc. Summary of Background Data. There is no clinical report comparing CHARITÉ and ProDisc. Methods. Among a total of 61 patients who underwent total disc replacement, 57 patients followed more than 3 years were enrolled. The CHARITÉ was used in 33 patients and ProDisc in 24. MRI follow-up was possible in 52 patients. Clinical and radiologic data including range of motion (ROM) and facet degeneration of the replaced segment, and degeneration of the disc at the adjacent level were evaluated. Results. Mean percentage improvement of Oswestry Disability Index (ODI) score was 78.9% in the CHARITÉ group and 75.8% in ProDisc group. The mean improvement of the Visual Analogue Scale (VAS) pain score was 72% in the CHARITÉ and 74.2% in ProDisc. There was no statistical difference between 2 groups in improvement rates either of the ODI scores and VAS scores. Degradation of the facets was seen in 36.4% of the CHARITÉ and 32% of the ProDisc. Degradation of disc degeneration at the adjacent level above the index level was seen in 19.4% in the CHARITÉ and 28.6% in the ProDisc. The degradation rates of facet joints and disc at adjacent segment between the 2 groups were not significantly different. Segmental ROM of the replaced segments was well preserved, but ROM of L5–S1 of the ProDisc was significantly less than that of the CHARITÉ. Conclusions. While clinical outcomes of both CHARITÉ and ProDisc groups were fairly good, the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of patients, regardless of the device used, raising concerns of possible late consequences of total disc replacement, especially regarding facet arthrosis and adjacent segment disease.