Cervical Disc Arthroplasty: Rationale, Designs, and Results of Randomized Controlled Trials.

IF 1.7 Q2 SURGERY

International Journal of Spine Surgery Pub Date : 2024-02-27 DOI:10.14444/8586

Djani M Robertson, Andy Ton, Michael Brown, Shane Shahrestani, Emily S Mills, Jeffrey C Wang, Raymond J Hah, Ram K Alluri

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引用次数: 0

Abstract

Background: This review outlines clinical data and characteristics of current Food and Drug Administration (FDA)-approved implants in cervical disc replacement/cervical disc arthroplasty (CDR/CDA) to provide a centralized resource for spine surgeons.

Methods: Randomized controlled trials (RCTs) on CDR/CDA were identified using a search of the PubMed, Web of Science, and Google Scholar databases. The initial search identified 69 studies. Duplicates were removed, and the following inclusion criteria were applied when determining eligibility of RCTs for the current review: (1) discussing CDR/CDA prosthesis and (2) published within between 2010 and 2020. Studies without clinical data or that were not RCTs were excluded. All articles were reviewed independently by 2 authors, with the involvement of an arbitrator to facilitate consensus on any discrepancies.

Results: A total of 34 studies were included in the final review. Findings were synthesized into a comprehensive table describing key features and clinical results for each FDA-approved CDR/CDA implant and are overall suggestive of expanding indications and increasing utilization.

Conclusions: RCTs have provided substantial evidence to support CDR/CDA for treating single- and 2-level cervical degenerative disc disease in place of conventional anterior cervical discectomy and fusion.

Clinical relevance: This review provides a resource that consolidates relevant clinical data for current FDA-approved implants to help spine surgeons make an informed decision during preoperative planning.

Level of evidence: 5:

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颈椎椎间盘置换术：随机对照试验的原理、设计和结果。

背景：本综述概述了目前美国食品和药物管理局（FDA）批准的颈椎间盘置换术/颈椎间盘关节成形术（CDR/CDA）植入物的临床数据和特点，为脊柱外科医生提供了一个集中的资源：方法：通过搜索 PubMed、Web of Science 和 Google Scholar 数据库，确定了有关 CDR/CDA 的随机对照试验 (RCT)。初步搜索确定了 69 项研究。删除了重复的研究，在确定是否有资格纳入本次研究时，采用了以下纳入标准：(1) 讨论 CDR/CDA 假体；(2) 2010 年至 2020 年间发表。无临床数据或非 RCT 的研究被排除在外。所有文章均由两名作者独立审阅，并由一名仲裁员参与，以便就任何不一致之处达成共识：共有 34 项研究被纳入最终审查。研究结果汇总成一个综合表格，描述了每个经 FDA 批准的 CDR/CDA 植入物的主要特征和临床结果，总体上表明适应症在不断扩大，使用率在不断提高：RCT提供了大量证据支持CDR/CDA用于治疗单层和两层颈椎间盘退行性病变，以取代传统的颈椎前路椎间盘切除术和融合术：本综述提供了一个资源，整合了目前FDA批准的植入物的相关临床数据，以帮助脊柱外科医生在术前规划时做出明智的决定：5:

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来源期刊

International Journal of Spine Surgery Medicine-Surgery

CiteScore

3.10

自引率

0.00%

发文量

162

期刊介绍： The International Journal of Spine Surgery is the official scientific journal of ISASS, the International Intradiscal Therapy Society, the Pittsburgh Spine Summit, and the Büttner-Janz Spinefoundation, and is an official partner of the Southern Neurosurgical Society. The goal of the International Journal of Spine Surgery is to promote and disseminate online the most up-to-date scientific and clinical research into innovations in motion preservation and new spinal surgery technology, including basic science, biologics, and tissue engineering. The Journal is dedicated to educating spine surgeons worldwide by reporting on the scientific basis, indications, surgical techniques, complications, outcomes, and follow-up data for promising spinal procedures.