Epstein Nancy E, Agulnick Marc A
Clinical Professor of Neurosurgery, School of Medicine, State University of NY at Stony Brook, and Editor-in-Chief Surgical Neurology International NY and ℅ Dr. Marc Agulnick 1122 Frankllin Avenue Suite 106, Garden City, NY 11530, USA.
Assistant Clinical Professor of Orthopedics, NYU Langone Hospital, Long Island, NY, USA. 1122 Franklin Avenue Suite 106 Garden City, NY 11530.
Surg Neurol Int. 2022 Dec 2;13:565. doi: 10.25259/SNI_1028_2022. eCollection 2022.
BACKGROUND: We performed a focused review to determine the "non-inferiority", potential superiority, and relative safety/efficacy for performing cervical disc arthroplasty (CDA)/total disc replacement (TDR) in carefully selected patients vs. anterior cervical diskectomy/fusion (ACDF). Notably, CDA/TDR were devised to preserve adjacent level range of motion (ROM), reduce the incidence of adjacent segment degeneration (ASD), and the need for secondary ASD surgery. METHODS: We compared the incidence of ASD, reoperations for ASD, safety/efficacy, and outcomes for cervical CDA/TDR vs. ACDF. Indications, based upon the North American Spine Society (NASS) Coverage Policy Recommendations (Cervical Artificial Disc Replacement Revised 11/2015 and other studies) included the presence of radiculopathy or myelopathy/myeloradiculopathy at 1-2 levels between C3-C7 with/without neck pain. Contraindications for CDA/TDR procedures as quoted from the NASS Recommendations (i.e. cited above) included the presence of; "Infection…", "Osteoporosis and Osteopenia", "Instability…", "Sensitivity or Allergy to Implant Materials", "Severe Spondylosis…", "Severe Facet Joint Arthropathy…", "Ankylosing Spondylitis" (AS), "Rheumatoid Arthritis (RA), Previous Fracture…", "Ossification of the Posterior Longitudinal Ligament (OPLL)", and "Malignancy…". Other sources also included spinal stenosis and scoliosis. RESULTS: Cervical CDA/TDR studies in the appropriately selected patient population showed no inferiority/ occasionally superiority, reduced the incidence of ASD/need for secondary ASD surgery, and demonstrated comparable safety/efficacy vs. ACDF. CONCLUSION: Cervical CDA/TDR studies performed in appropriately selected patients showed a "lack of inferiority", occasional superiority, a reduction in the incidence of ASD, and ASD reoperation rates, plus comparable safety/efficacy vs. ACDF.
背景:我们进行了一项重点综述,以确定在精心挑选的患者中进行颈椎间盘置换术(CDA)/全椎间盘置换术(TDR)相对于前路颈椎间盘切除融合术(ACDF)的“非劣效性”、潜在优势以及相对安全性/有效性。值得注意的是,CDA/TDR旨在保留相邻节段的活动范围(ROM),降低相邻节段退变(ASD)的发生率以及二次ASD手术的需求。 方法:我们比较了颈椎CDA/TDR与ACDF的ASD发生率、ASD再次手术率、安全性/有效性及结果。依据北美脊柱协会(NASS)覆盖政策建议(2015年11月修订的颈椎人工椎间盘置换及其他研究),适应症包括C3 - C7之间1 - 2个节段存在神经根病或脊髓病/脊髓神经根病,伴有或不伴有颈部疼痛。NASS建议(即上述引用)中CDA/TDR手术的禁忌症包括存在;“感染……”、“骨质疏松症和骨质减少”、“不稳定……”、“对植入材料敏感或过敏”、“严重脊柱关节病……”、“严重小关节病……”、“强直性脊柱炎”(AS)、“类风湿性关节炎”(RA)、既往骨折……、“后纵韧带骨化”(OPLL)以及“恶性肿瘤……”。其他来源还包括椎管狭窄和脊柱侧弯。 结果:在适当选择的患者群体中进行的颈椎CDA/TDR研究显示无劣效性/偶尔有优势,降低了ASD发生率/二次ASD手术需求,且与ACDF相比安全性/有效性相当。 结论:在适当选择的患者中进行颈椎CDA/TDR研究显示出“无劣效性”、偶尔有优势、ASD发生率降低以及ASD再次手术率降低,并且与ACDF相比安全性/有效性相当。
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