Zavras Athan G, Federico Vincent P, Butler Alexander J, Nolte Michael T, Dandu Navya, Phillips Frank M, Colman Matthew W
Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA.
Global Spine J. 2024 Jan;14(1):322-346. doi: 10.1177/21925682231172982. Epub 2023 Apr 26.
Systematic Review and Meta Analysis.
This study sought to compare patient-reported outcomes, success, complications, and radiographic outcomes directly and indirectly between different cervical total disc arthroplasty (TDA) devices and anterior cervical discectomy and fusion (ACDF).
Patients of prospective randomized controlled trials of 1-level cervical TDA with a minimum of 2 years follow up were identified in the literature. A frequentist network meta-analysis model was used to compare each outcome across the different TDA devices included and ACDF using the mixed effect sizes.
15 studies were included for quantitative analysis, reporting the outcomes of 2643 patients with an average follow-up was 67.3 months (range: 24-120 months), 1417 of whom underwent TDA and 1226 of whom underwent ACDF. Nine TDA devices were compared to ACDF, including the Bryan, Discover, Kineflex, M6, Mobi-C, PCM, Prestige ST, ProDisc-C, and Secure-C cervical prostheses. Several devices outperformed ACDF for certain outcomes, including Visual Analog Scale (VAS) Arm, Physical Component Score of the Short-Form Health Survey (SF PCS), neurological success, satisfaction, index-level secondary surgical interventions (SSI), and adjacent level surgeries. Cumulative ranking of each intervention assessed demonstrated the highest performance with the M6 prosthesis ( = .70), followed by Secure-C ( = .67), PCM ( = .57), Prestige ST ( = .57), ProDisc-C ( = .54), Mobi-C ( = .53), Bryan ( = .49), Kineflex ( = .49), Discover ( = .39), and ACDF ( = .14).
Cervical TDA was found to be superior on most outcomes assessed in the literature of high-quality clinical trials. While most devices demonstrated similar outcomes, certain prostheses such as the M6 were found to outperform others across several outcomes assessed. These findings suggest that the restoration of near-normal cervical kinematics may lead to improved outcomes.
系统评价与荟萃分析。
本研究旨在直接和间接比较不同颈椎全椎间盘置换术(TDA)装置与颈椎前路椎间盘切除融合术(ACDF)之间患者报告的结局、成功率、并发症及影像学结局。
在文献中识别出至少随访2年的1节段颈椎TDA前瞻性随机对照试验的患者。采用频率学派网状荟萃分析模型,使用混合效应量比较纳入的不同TDA装置与ACDF的各项结局。
纳入15项研究进行定量分析,报告了2643例患者的结局,平均随访67.3个月(范围:24 - 120个月),其中1417例接受TDA,1226例接受ACDF。将9种TDA装置与ACDF进行比较,包括Bryan、Discover、Kineflex、M6、Mobi - C、PCM、Prestige ST、ProDisc - C和Secure - C颈椎假体。在某些结局方面,几种装置优于ACDF,包括视觉模拟量表(VAS)上肢评分、简短健康调查问卷的身体成分评分(SF PCS)、神经功能成功率、满意度、索引节段二次手术干预(SSI)及相邻节段手术。对每种干预措施评估的累积排名显示,M6假体表现最佳(= 0.70),其次是Secure - C(= 0.67)、PCM(= 0.57)、Prestige ST(= 0.57)、ProDisc - C(= 0.54)、Mobi - C(= 0.53)、Bryan(= 0.49)、Kineflex(= 0.49)、Discover(= 0.39)和ACDF(= 0.14)。
在高质量临床试验文献中评估的大多数结局方面,颈椎TDA被发现更具优势。虽然大多数装置显示出相似的结局,但在评估的多个结局方面,某些假体如M6被发现优于其他假体。这些发现表明,恢复接近正常的颈椎运动学可能会带来更好的结局。