St. Joseph's University Medical Center, Department of Orthopaedic Surgery, 703 Main Street, Paterson, NJ 07503, USA.
St. Joseph's University Medical Center, Department of Orthopaedic Surgery, 703 Main Street, Paterson, NJ 07503, USA.
Spine J. 2021 Nov;21(11):1830-1838. doi: 10.1016/j.spinee.2021.04.018. Epub 2021 Apr 30.
Although highlighted in joint arthroplasty studies, long-term outcomes between differing biomaterial composites, such as metal-on-metal (MoM) and metal-on-plastic (MoP) in anterior cervical disc replacement (ACDR) have not been thoroughly investigated.
The purpose of this study was to evaluate the patient-reported clinical outcomes, overall reoperation rates, complications, and rates of ASD of MoM versus MoP artificial discs in two-level ACDR for the treatment of cervical DDD.
STUDY DESIGN/SETTING: Meta-analysis and systematic review.
Nine hundred eighty patients (442 MoM, 538 MoP) across seven studies.
Patient reported clinical outcomes (NDI, VAS-n, VAS-a), overall reoperation rates, complications, and rates of ASD.
A systematic search strategy of three electronic databases (PubMed, CINAHL Plus, and SCOPUS) was conducted utilizing terms related to two-level ACDR. All studies included had a sample size of >10 patients, had a minimum 5-year follow-up, and reported data on adjacent segment disease. Cadaver studies, non-English manuscripts, articles with less than 5-year follow-up and studies in which only single-level ACDR was investigated were excluded. A total of seven studies were included in this analysis. Studies were analyzed for demographic data, clinical outcome scores (NDI, VAS-neck, and VAS-arm), overall reoperation rates, complications, and rates of ASD. A random-effects model of meta-analysis was used for groups that were determined to be heterogenous and a fixed-effects model was utilized for groups that were not. An overlap of 95% confidence intervals suggests no statistically significant difference at the p<.05 level.
Seven studies were included with data on 980 patients (442 MoM, 538 MoP). The study population was 52.84% female, with a mean age of 48.01 years, and a mean follow-up of 85.66 months. The mean improvement in NDI was 34.42 (95% CI, 32.49-36.36) and 29.72 (95% CI, 27.15-32.29) for the MoM and MoP groups, respectively. The mean improvement in VAS-neck was 11.20 (95% CI, 10.69-11.70) and 8.78 (95% CI, 7.81-9.74) for the MoM and MoP groups, respectively. The mean improvement in VAS-arm was 10.73 (95% CI, 9.83-11.63) and 8.49 (95% CI, 7.59-9.39) for the MoM and MoP groups, respectively. 3.85% (95% CI, 2.40-6.10) of patients who underwent ACDR with a MoM implant required reoperation compared to 5.33% (95% CI, 3.68-7.65) of patients with a MoP implant. Heterotopic ossification and dysphagia were the most common complications in both groups. The MoM cohort showed a higher incidence of HO (72.62% vs. 21.07%), but a lower incidence of dysphagia (0.96% vs. 16.31%) compared to the MoP cohort. The MoM cohort had a larger proportion of patients with ASD who underwent subsequent surgery at an adjacent level (7.89% MoM versus 1.91% MoP).
Our present meta-analysis suggests that the use of MoM artificial discs in two-level ACDR results in superior clinical outcome score improvement, but higher rates of ASD requiring secondary surgery compared to MoP discs after a follow-up period of 5 years or more.
虽然在关节置换研究中得到了强调,但金属对金属(MoM)和金属对塑料(MoP)等不同生物材料复合材料在颈椎前路椎间盘置换(ACDR)中的长期结果尚未得到彻底研究。
本研究的目的是评估在治疗颈椎退行性椎间盘疾病的双节段 ACDR 中,MoM 与 MoP 人工椎间盘的患者报告临床结果、总体再次手术率、并发症和 ASD 发生率。
研究设计/设置:荟萃分析和系统回顾。
来自 7 项研究的 980 名患者(MoM 组 442 名,MoP 组 538 名)。
患者报告的临床结果(NDI、VAS-n、VAS-a)、总体再次手术率、并发症和 ASD 发生率。
对三个电子数据库(PubMed、CINAHL Plus 和 SCOPUS)进行了系统搜索策略,使用与双节段 ACDR 相关的术语。所有纳入的研究样本量均>10 例,随访时间>5 年,并报告了邻近节段疾病的数据。排除了尸体研究、非英语文献、随访时间<5 年以及仅研究单节段 ACDR 的研究。共有 7 项研究纳入了本分析。分析了研究的人口统计学数据、临床结果评分(NDI、VAS-颈和 VAS-臂)、总体再次手术率、并发症和 ASD 发生率。确定为异质性的组采用随机效应模型的荟萃分析,而不是异质性的组采用固定效应模型。95%置信区间的重叠表明在 p<.05 水平没有统计学上的显著差异。
本荟萃分析纳入了 7 项研究,共 980 名患者(MoM 组 442 名,MoP 组 538 名)。研究人群中 52.84%为女性,平均年龄为 48.01 岁,平均随访时间为 85.66 个月。MoM 组和 MoP 组的 NDI 平均改善分别为 34.42(95%CI,32.49-36.36)和 29.72(95%CI,27.15-32.29)。MoM 组和 MoP 组的 VAS-颈平均改善分别为 11.20(95%CI,10.69-11.70)和 8.78(95%CI,7.81-9.74)。MoM 组和 MoP 组的 VAS-臂平均改善分别为 10.73(95%CI,9.83-11.63)和 8.49(95%CI,7.59-9.39)。与 MoP 组相比,接受 MoM 植入物的 ACDR 患者中有 3.85%(95%CI,2.40-6.10)需要再次手术,而接受 MoP 植入物的患者中有 5.33%(95%CI,3.68-7.65)。异位骨化和吞咽困难是两组最常见的并发症。MoM 队列的 HO 发生率较高(72.62% vs. 21.07%),但吞咽困难发生率较低(0.96% vs. 16.31%)。与 MoP 队列相比,MoM 队列中 ASD 患者比例较高,需要在相邻水平进行后续手术(7.89% MoM 与 1.91% MoP)。
我们目前的荟萃分析表明,在 5 年或更长时间的随访后,与 MoP 人工椎间盘相比,双节段 ACDR 中使用 MoM 人工椎间盘可获得更好的临床结果评分改善,但 ASD 发生率更高,需要二次手术。